tag:blogger.com,1999:blog-11781729591421157572024-03-13T13:59:39.102-07:00Pharmatext[Free Pharma E-Books]Unknownnoreply@blogger.comBlogger743125tag:blogger.com,1999:blog-1178172959142115757.post-68014430823009673552019-08-07T21:20:00.002-07:002019-08-07T21:21:25.216-07:00Commerce Ministry to Implement Online System for Tracing & Authentication of Export From April, 2020<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://1.bp.blogspot.com/-CmdLRc0POyM/XUui3UG4qDI/AAAAAAAAn00/TGytntdY1_QLU4cfhXxY5TvtBvmRpYAzgCLcBGAs/s1600/Drug_Export_from_India.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="340" data-original-width="501" height="271" src="https://1.bp.blogspot.com/-CmdLRc0POyM/XUui3UG4qDI/AAAAAAAAn00/TGytntdY1_QLU4cfhXxY5TvtBvmRpYAzgCLcBGAs/s400/Drug_Export_from_India.png" width="400" /></a></div>
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The Union Ministry of Commerce, through the Centre for Development of Advanced Computing (C-DAC), will implement online system for tracing and authentication of pharmaceutical export packages from April 1, 2020.</div>
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The online system is envisaged to help manufacturers and merchant traders to generate and utilise tertiary and secondary level coded data in a user-friendly manner. </div>
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“Industry is very happy with the government initiative which will solve problems for track and trace,” says Nipun Jain, chairman, SME panel, Pharmexcil.</div>
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Simplified tracing system for authentication of drug packages will act as a single window integrated system that will enable the tracing of an exported pharmaceutical product. It has the provision to upload product and production data.</div>
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It also has provisions to create virtual tertiary and secondary packages and generation of unique identification for manufacturers, merchant exporters (Labeler Code), products (Product Code), and Packages (Package Code- Primary, Secondary, Tertiary Packs). </div>
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It will also help in tracing of pharmaceutical product exported using Unique ID and QR Code. </div>
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System is based out of simplistic workflow and hence takes care of both manufacturers and merchant exporters. </div>
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With this system, tertiary and secondary packing will be taken care with their corresponding unique serial numbers and there is no need of duplication of SSCC and tertiary generated by proposed system.</div>
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The proposed system is for Indian government’s tracing and tracking mechanism for export purposes, therefore it is independent of the product coding systems used by a manufacturer.</div>
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It facilitates ease of tracking of packages and products using Unique ID. An App shall be provided to verify product details upon entering unique Id.</div>
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The proposed system shall provide feasibility of generation of primary codes from software to printing systems directly and avoid manual or third party intervention. E-sign of Government of India shall be used (Aadhar based) instead of digital signatures. For products verification, the listing may be taken from authentic source like SUGAM, Central Drugs Standard Control Organisation (CDSCO). </div>
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Unknownnoreply@blogger.com3tag:blogger.com,1999:blog-1178172959142115757.post-16302615665024958802019-03-15T04:22:00.000-07:002019-03-16T01:28:34.047-07:00"Digital Link Syntax” - A new #GS1 Standard for Product Authentication<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://2.bp.blogspot.com/-tzOzkKDgzt4/XIuKpL1aAoI/AAAAAAAAkJM/20w0gfqJFeot3LrdsgFkyAJ92cd9HV4CACLcBGAs/s1600/GS1_new_Standard.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="669" data-original-width="1000" height="267" src="https://2.bp.blogspot.com/-tzOzkKDgzt4/XIuKpL1aAoI/AAAAAAAAkJM/20w0gfqJFeot3LrdsgFkyAJ92cd9HV4CACLcBGAs/s400/GS1_new_Standard.jpg" width="400" /></a></div>
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GS1 has recently published their technical guideline for Verification Router service where they intended to provide a simple standardized lightweight messaging framework for verification of saleable return and enables wholesaler/distributor to determine what immediate action should be taken based on authentication check.</div>
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Under the Drug Supply Chain Security Act, beginning November 27, 2019, wholesaler distributors are required to verify the product identifier of returned product before placing them into inventory for resale. A manufacturer who receives a verification request from a repackager, wholesale distributor, or dispenser must respond to that request within 24 hours. Supply chain parties are expected to exchange information in “a secure, interoperable, electronic manner in accordance with the standards</div>
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GS1 advances with Digital Link Syntax</div>
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First time GS1 standard is including JSON as a message response syntax; it is also the first GS1 “Share” standard to leverage the new GS1 Digital Link (Web URI) standard for the request syntax.</div>
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GS1 technical standard to make use of the new GS1 Digital Link syntax in order to enable a basic automated authenticity check of a serialized product identifier with batch and expiry date via a lightweight web-based request/response message pair, initiated by a simple HTTP/HTTPS GET request and returning a lightweight machine-readable response message formatted in JavaScript Object Notation (JSON). </div>
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In current practice, a product is uniquely identified by following elements and encoded in GS1 2D DataMatrix barcode.</div>
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(01)00361414567894(17)220228(10)E1908672(21)721234567872</div>
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(01){gtin}(17){exp}(10){lot}(21){ser}</div>
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The GS1 Digital Link (Web URI) syntax provides an alternative way to express GTIN, serial number, lot/batch and expiry date within a single Web URI format. GS1 element strings can also be translated into a GS1 Digital Link Web URI with the following structure or URI template:</div>
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https://id.gs1.org/gtin/{gtin}/lot/{lot}/ser/{ser}?exp={exp}</div>
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where</div>
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{gtin}, {exp}, {lot} and {ser} are placeholders for the actual values, such as:</div>
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Example</div>
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https://id.gs1.org/gtin/00361414567894/lot/ E1908672/ser/721234567872?exp=220228</div>
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The GS1 Digital Link syntax is simply an alternative way of expressing a concatenation of one or more GS1 element strings but formatted in a way that functions as a web address. It is important to note that the GS1 Digital Link syntax does not require any changes whatsoever to current practices of marking products with GS1 barcodes, whether 1-D or 2-D; pharmaceutical packages will continue to be marked using GS1 DataMatrix symbols that encode the four elements above.</div>
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As part of the adoption strategy for GS1 Digital Link, GS1 is currently developing free open source translation functions (in JavaScript, PHP and Java) that will enable translation between GS1 element strings and the GS1 Digital Link / Web URI syntax, in both directions. This can then be included within the software / firmware of barcode scanners or further downstream, within information systems, so that the GS1 Digital Link / Web URI syntax can always be generated on demand, whenever it is required, without requiring any change to how GS1 identifiers are currently encoded and marked on product packaging. In other words, it will be possible to scan a set of four element strings (GTIN, Lot/Batch, Serial Number and Expiry Date) from an existing GS1 DataMatrix barcode on a product package, and have that GS1 element string translated into a GS1 Digital Link Web URI format whenever it is useful to do so.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-6770845086021776112018-07-19T00:18:00.001-07:002018-07-19T00:19:30.207-07:00The 5th Generation of Cephalosporins<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://2.bp.blogspot.com/-aP8I5GMClFs/W1A7ICa3jXI/AAAAAAAAcsQ/9jzxwMOMUkksaTJB_bD-dViDfvfIsm2OQCLcBGAs/s1600/5thgen.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="455" data-original-width="643" height="282" src="https://2.bp.blogspot.com/-aP8I5GMClFs/W1A7ICa3jXI/AAAAAAAAcsQ/9jzxwMOMUkksaTJB_bD-dViDfvfIsm2OQCLcBGAs/s400/5thgen.png" width="400" /></a></div>
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Since their discovery in the 1950s, cephalosporins have become one of the largest classes of antibiotics. The class is divided into generations or subclasses, which are grouped by chemical properties and subsequent generalized microbiologic spectra.</div>
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Cephalosporins have been used to treat a variety of infections, from mild to life-threatening; however, like all antibiotics, resistance has been identified in bacteria. This typically occurs when the medications bind to an active site serine that is located on all functional penicillin-binding proteins (PBPs). The resulting inactive enzyme slowly hydrolyzes the antibiotic so that it forms an inactive entity compared with the bacteria.1</div>
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To address antibacterial resistance, the Generating Antibiotic Incentives Now provision of the FDA Safety and Innovation Act (FDASIA; Public Law 112-144) created the designation of “qualified infectious disease products” (QIDPs).2 This status is granted to agents that are intended to treat dangerous or life-threatening infections caused by resistant, novel, or emerging pathogens or those listed within the FDASIA. The agents receive an additional 5 years of patent exclusivity and priority and fast-track FDA review. In 2015, <b>ceftolozane/tazobactam (Zerbaxa) became the fourth and ceftazidime/avibactam (Avycaz) became the fifth QIDP to receive FDA approval.3,4 Together, these new cephalosporins have been referred to as fifth-generation cephalosporins, or new-generation cephalosporins (NGCs).</b></div>
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<b>PHARMACOLOGY:</b></div>
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Both NGCs are bactericidal agents that bind to PBPs, the essential enzymes involved in the final step of cell wall biosynthesis in both Gram-positive and Gram-negative organisms. 1,3,4 Each is attached to a beta-lactamase inhibitor that does not possess clinically relevant in vitro activity against bacteria but does serve to protect the cephalosporin from degradation. Tazobactam, combined with the novel cephalosporin ceftolozane, is an irreversible inhibitor of class A penicillinases and class C cephalosporinases and forms covalent bonds to some chromosomal and plasma-mediated beta-lactamases. 2,6 Avibactam, a novel beta-lactamase inhibitor combined with ceftazidime, the established third-generation cephalosporin, inhibits class A penicillinases, extended-spectrum beta-lactamases (ESβLs), class C cephalosporinases, class D oxacillinases, and serine carbapenemases.1,5,7</div>
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<b>MICROBIOLOGY:</b></div>
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Ceftolozane/tazobactam and ceftazidime/avibactam have shown efficacy against a large number of pathogens. Both NGCs demonstrate in vitro activity against enterobacteriaceae in the presence of certain beta-lactamases and ES Ls and are effective against Pseudomonas aeruginosa, including some resistant isolates.6,7 Only ceftazidime/avibactam, however, is effective against Klebsiella pneumoniae carbapenemases. 7 Ceftolozane/tazobactam also has shown efficacy against Streptococcus species and the anaerobic pathogens Bacteroides fragilis and Fusobacterium species.6 Neither NGC is effective against the Enterococcus species and therefore may not provide adequate empiric coverage for all patients with a nitrate-negative urinalysis.</div>
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<b>THERAPEUTIC USE:</b></div>
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The NGCs are FDA approved for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and complicated intraabdominal infections (cIAIs).6,7 cIAIs include intraabdominal abscesses, peritonitis, gastric or duodenal perforation, intestinal perforation, appendicitis, cholecystitis, and diverticulitis. When treating cIAIs, metronidazole must be used with the NGCs to provide coverage against anaerobic organisms. The NGCs should be used only in patients 18 years old or older, when treating infections known or strongly suspected to be caused by susceptible organisms, and reserved for patients with no or limited antibacterial alternatives.</div>
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<b>DOSING AND ADMINISTRATION:</b></div>
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NGCs are parenteral antibiotics that are administered every 8 hours to adult patients with a creatinine clearance >50 mL/min.6,7 Dosing for each antibiotic is the same for the 2 approved indications. Ceftazidime/avibactam 2.5 g (2 g/0.5 g) should be infused during a 2-hour period, whereas ceftolozane/tazobactam 1.5 g (1 g/0.5 g) only requires a 1-hour infusion. The dose of ceftolozane/tazobactam is reduced with declining kidney function (creatinine clearance ≤50 mL/min), but the 8-hour frequency is unchanged. In contrast, decreased dosing and extended interval frequency are required for ceftazidime/avibactam when the creatinine clearance is ≤50 mL/min.</div>
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The duration of therapy differs between the 2 agents and by indication. A cUTI should be treated for at least 7 dayswith either NGC, although it may require up to 14 days with ceftazidime/avibactam.6,7 Patients with a cIAI should receive ceftolozane/tazobactam for 4 to 14 days or ceftazidime/ avibactam for 5 to 14 days. When used to treat cIAI, intravenous metronidazole 500 mg every 8 hours also should be administered.</div>
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<b>COMPARATIVE EFFICACY:</b></div>
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To the author’s knowledge, no head-to-head studies between the 2 NGCs have been conducted. The approvals of both NGCs for cIAIs were based on the results of similar large clinical trials of hospitalized patients in which the NGC plus metronidazole was compared with meropenem.6,7</div>
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Ceftolozane/tazobactam was evaluated in a multinational noninferiority study of 979 patients that assessed clinical response, defined as complete resolution or significant improvement in signs and symptoms of the infection 24 to 32 days after the first dose of the study drug.6 Ceftolozane/ tazobactam plus metronidazole was shown to be noninferior to meropenem in clinical response (83% vs 87.3%; observed difference, −4.3% [95% CI, −9.2% to 0.7%]). A subanalysis of Escherichia coli and K pneumoniae isolates used genotypic testing to identify ESβL groups in 9% of isolates, with clinical cure rates being similar between the groups.</div>
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Ceftazidime/avibactam also was evaluated in a multinational noninferiority study in combination with metronidazole compared with meropenem alone.7 The study enrolled 1058 patients to evaluate clinical cure, which had the same definition as previously noted for clinical response, but was evaluated at 28 to 35 days after enrollment. Ceftazidime/avibactam plus metronidazole also was shown to be noninferior to meropenem alone (81.6% vs 85.1%; observed difference, −3.5% [95% CI, −8.6% to 1.6%]). A subanalysis of genotypic testing for ESβLs also was conducted, with cure rates continuing to be similar between the 2 groups.</div>
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Ceftolozane/tazobactam was approved by the FDA for the treatment of cUTIs based on a multinational study of 1068 patients that compared cephalosporin with levofloxacin for 7 days.8 The primary endpoint was complete resolution or marked improvement of clinical symptoms and microbiological eradication at 7 days after the last dose of the medication. Ceftolozane/tazobactam was shown to have better efficacy compared with levofloxacin (76.9% vs 68.4%; observed difference, 8.5% [95% CI, 2.3%-14.6%]), but 26.5% of patients had isolates that were resistant to levofloxacin. Among the patients with levofloxacin-sensitive organisms, efficacy was similar between the 2 antibiotics (82.6% vs 79.7%; no 95% CI provided).</div>
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The approval of ceftazidime/avibactam for cUTIs was granted predominantly based on the results of previous studies on the efficacy and safety of ceftazidime alone forcUTIs7; the contribution of avibactam to the efficacy of the medication was supported by in vitro and animal studies.7 Ceftazidime/avibactam was compared with imipenem-cilastatin in a phase 2 randomized multicenter study of hospitalized patients with cUTIs caused by Gram-negative organisms. 9 The cure’s effectiveness was evaluated in 62 patients who were microbiologically evaluable 5 to 9 days after therapy, with a favorable microbiologic response similar between the groups (70.4% vs 71.4%; observed difference, −1.1% [95% CI, −27.2% to 25%]).</div>
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Ceftazidime/avibactam also was compared with doripenem in a postapproval phase 3 noninferiority study for 10 days (up to 14 days, if bacteremia was detected) in 1033 patients with cUTIs.10 Ceftazidime/avibactam was shown to be noninferior to doripenem in patient-reported symptomatic resolution at day 5 (70.2% vs 66.2%; observed difference, 4% [95% CI, −2.39% to 10.42%]) and combined symptomatic resolution and microbiological eradication at test of cure (71.2% vs 64.5%; observed difference, 6.7% [95% CI, 0.3%-13.12%]).</div>
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<b>ADVERSE EFFECTS:</b></div>
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Adverse effects (AEs) with NGCs typically are mild, but there are several common and serious AEs worth noting. Both agents cause nausea and diarrhea in ≥5% of patients.6-10 Ceftazidime/avibactam also may cause constipation, diarrhea, abdominal pain, dizziness, or anxiety.7 Ceftazidime alone has been associated with more serious central nervous system (CNS) AEs, including seizures, encephalopathy, and coma.7 AEs with ceftolozane/tazobactam include headache and pyrexia.6 </div>
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<b>DRUG–DRUG INTERACTIONS:</b></div>
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Minimal drug–drug interactions have been observed with the NGCs. Both tazobactam and avibactam are substrates of organic anion transporter 1 (OAT1) and OAT3 kidney transporters.6,7 Probenecid, an inhibitor of these transporters, can prolong the half-life of the beta-lactamase inhibitors, and coadministration is not recommended. Cytochrome activity is not affected at clinically relevant blood concentrations, but at supratherapeutic blood concentrations, tazobactam may inhibit cytochrome P450 1A2 (CYP1A2), CYP2D6, and CYP3A4, and avibactam may induce CYP2E1.</div>
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<b>SAFETY ISSUES:</b></div>
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Ceftolozane/tazobactam and ceftazidime/avibactam are less effective in patients with a baseline creatinine clearance of 30 to ≤50 mL/min.6,7 Creatinine clearance should be monitored daily in patients receiving these antibiotics, and alternative agents, if available, against the target organism should be considered in patients whose kidney function fallsconsistently within these parameters. Studies of both NGCs reported more AEs in geriatric patients.6,7 Clostridium difficile- associated diarrhea has been reported with both agents, with severity ranging from mild to fatal.6,7 Caution should be exercised when determining whether to use either antibiotic in a patient with a penicillin or other beta-lactamase allergy because of the risk of cross-reactivity.</div>
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Serious CNS reactions are known to occur with ceftazidime, especially in patients with decreased kidney function.7 Reactions include seizures, encephalopathy, coma, asterixis, myoclonia, and neuromuscular excitability. Ceftazidime/ avibactam should be avoided in patients with other risk factors for these CNS effects whenever possible. However, if the combination must be used in patients with a creatinine clearance ≤50 mL/min, then the dosage should be adjusted to lessen the risk of CNS reactions.7 </div>
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Both NGCs should be protected from exposure to light.6,7 Ceftazidime/avibactam can be stored at a controlled roomtemperature (77°F, with excursions 59°-86°F permitted).7 Once mixed in fluid, it is stable for 12 hours at temperatures ranging from 68° to 77°F and for 24 hours if refrigerated. Ceftolozane/tazobactam should be refrigerated until it is reconstituted. After dilution, ceftolozane/tazobactam can be stored at room temperature for a maximum of 24 hours or in the refrigerator for up to 7 days.6 </div>
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Marilyn Novell Bulloch, PharmD BCPS, is an associate clinical professor of pharmacy practice at the Auburn University School of Pharmacy and an adjunct assistant professor at the University of Alabama School of Medicine College of Community Health Sciences Department of Internal Medicine. She serves on multiple committees and in leadership positions for many local, state, and national pharmacy and interdisciplinary medical organizations.</div>
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Unknownnoreply@blogger.com40tag:blogger.com,1999:blog-1178172959142115757.post-25590302502155767752017-05-18T07:48:00.000-07:002017-05-19T00:29:01.489-07:00Pharma Book by Mohan Patidar Unlocked pdf<div dir="ltr" style="text-align: left;" trbidi="on">
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Full 300 Pages Pharma Book by Mohan Patidar Unlocked pdf. Password protected copy viral on WhatsApp.</div>
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<b style="text-align: left;"><a href="https://sabercathost.com/4T1u/PHARMA_BOOK_www.pharmatext.co.in.pdf" target="_blank">Download</a> [Updated Link]</b></div>
Unknownnoreply@blogger.com3tag:blogger.com,1999:blog-1178172959142115757.post-8026425310974382952016-03-14T21:03:00.002-07:002016-03-14T21:03:45.046-07:00Download Gazette of India on complete List of Banned Medicines <div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://www.scribd.com/doc/304775914/GSR-of-banned-FDC-products" style="text-decoration: underline;" title="View GSR of banned FDC products on Scribd">GSR of banned FDC products</a></div>
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Unknownnoreply@blogger.com7tag:blogger.com,1999:blog-1178172959142115757.post-36105674809597796212016-01-03T19:38:00.002-08:002016-01-03T19:38:38.884-08:00GSR 1011(E) Draft Gazette Regarding Revision in Fees<div dir="ltr" style="text-align: left;" trbidi="on">
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-66571740899225087892015-10-27T22:37:00.000-07:002015-10-27T22:37:14.796-07:00New EU GMP Annex 16 - Certification by a Qualified Person and Batch Release<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://3.bp.blogspot.com/-5yayPOP5ugE/VjBcUsGfKWI/AAAAAAAAYW4/rL1zjUVvLys/s1600/EU_Pharmatext.co.in.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="250" src="http://3.bp.blogspot.com/-5yayPOP5ugE/VjBcUsGfKWI/AAAAAAAAYW4/rL1zjUVvLys/s400/EU_Pharmatext.co.in.jpg" width="400" /></a></div>
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A new version of Annex 16: Certification by a Qualified Person and Batch Release has been published on EU Commission web page. Deadline for coming into operation is 15.April.2016.</div>
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Unknownnoreply@blogger.com2tag:blogger.com,1999:blog-1178172959142115757.post-1658714153336025252015-04-29T23:04:00.001-07:002015-04-29T23:04:54.949-07:00Directory of Pharmaceutical Manufacturing Units India<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-LKxeYmxrRfM/VUHDDeWWktI/AAAAAAAAX38/JZajxn3gtRA/s1600/image002.gif" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="http://1.bp.blogspot.com/-LKxeYmxrRfM/VUHDDeWWktI/AAAAAAAAX38/JZajxn3gtRA/s1600/image002.gif" height="320" width="266" /></a></div>
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The present publication entitled ‘Directory of Pharmaceutical Manufacturing Units in India’ presents names, addresses alongwith their telephone numbers, email/websites, wherever available, of 10563 pharmaceutical manufacturers across the country. These manufacturing units have been dichotomized into two broad camps viz. ‘Formulation’ and ‘Bulk Drugs’. Within each of the two classes, the units have been arranged state-wise and then alphabetically within each state/UT. The state-wise and class-wise number of these units is given at the Annexure.</div>
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<b>Disclaimer:</b></div>
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The names, addresses and other details of pharmaceutical manufacturing units contained herein do not purport to be an authentic version of these units. No claim or right will accrue to any person or body by virtue of any entry in this Publication.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-28415821896439480832015-03-31T04:27:00.001-07:002015-03-31T04:27:27.042-07:00Guidelines for Inspection of GMP Compliance by Ayurveda, Siddha & Unani Drug Industry<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://2.bp.blogspot.com/-T2I5-S7lan4/VRqCXedmwMI/AAAAAAAAXvg/6OMb5MHwln8/s1600/GMP_Ayurveda.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="http://2.bp.blogspot.com/-T2I5-S7lan4/VRqCXedmwMI/AAAAAAAAXvg/6OMb5MHwln8/s1600/GMP_Ayurveda.png" height="320" width="245" /></a></div>
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Drugs and Cosmetics Act 1940 and Rules thereunder provide for appointment of Inspectors of Ayurveda, Siddha & Unani (ASU) systems of medicines who play significant role in implementation</div>
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of Drugs & Cosmetics (D&C) Act 1940 and Rules thereunder. One of the important tasks of Inspectors working under the State Licensing Authority of ASU systems is inspection of ASU Drug manufacturing Units before issuing license to manufacture ASU drugs under the provisions of the D&C Act and Rules thereunder.</div>
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Training level and experience of Inspectors for the purpose of regulatory implementation varies because qualifications prescribed for Drug Inspectors of ASU drugs vary. The Inspector may be a graduate in Pharmacy/ Pharmaceutical Chemistry/ Medicine (with specialization in Clinical pharmacology or Microbiology) having undergone practical training in the manufacture of ASU drugs or having a Degree/Diploma in A/S/U systems of medicines or possessing Degree in Ayurveda Pharmacy as per the provisions of the Act and Rules thereunder. Under such circumstances when the qualifications and experience levels of inspectors vary, it is important to impart comprehensive knowledge of the D&C Act and Rules thereunder to the inspectors for facilitating uniform implementation of the Act. This is all more important as there is no induction training when the person with requisite qualification is assigned the job of an inspector. In many of the States, due to lack of dedicated manpower for enforcement of provisions of Drugs & Cosmetics Act, ASU doctors working in the Hospitals/ Dispensaries are designated as inspectors usually without any additional capacity building training specifically on analytical aspects. In such a situation this manual becomes even more essential.</div>
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This inspection manual covering various aspects about the qualifications, duties and responsibilities of inspectors will be a much needed helpful guide for orientation of ASU inspectors for proper discharge of their duties under D&C Act and Rules thereunder. The Guidelines for Inspection of GMP compliance by ASU drug industry are especially explained in detail for development of insight of the inspectors regarding interpretation and implementation of the Rules. This manual is expected to assist State Licensing Authorities to augment the regulatory capacities of inspectors and develop master trainers as well.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-32664691467155564862013-12-17T03:17:00.000-08:002013-12-17T03:17:29.277-08:00Drugs & Cosmetics (Amendment) Bill, 2013<div dir="ltr" style="text-align: left;" trbidi="on">
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Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-1178172959142115757.post-68675599450713642682013-12-13T23:51:00.002-08:002023-06-26T03:11:35.246-07:00Drug Delivery and Targeting: For Pharmacists and Pharmaceutical Scientists<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-9GejMNogiGc/UqwNQobCHxI/AAAAAAAATSI/I4R54MOU7BQ/s1600/ddtra.png" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://1.bp.blogspot.com/-9GejMNogiGc/UqwNQobCHxI/AAAAAAAATSI/I4R54MOU7BQ/s1600/ddtra.png" width="238" /></a></div>
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The advances in biotechnology and molecular biology over recent years have resulted in a large number of novel molecules with the potential to revolutionize the treatment and prevention of disease. However, such potential is severely compromised by significant obstacles to delivery of these drugs in vivo. These obstacles are often so great that effective drug delivery and targeting is now recognized as the key to effective development of many therapeutics. </div>
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Advanced drug delivery and targeting can offer significant advantages to conventional drugs, such as increased efficiency, convenience, and the potential for line extensions and market expansion. An accessible and easy-to-read textbook, Drug Delivery and Targeting for Pharmacists and Pharmaceutical Scientists is the first book to provide a comprehensive introduction to the principles of advanced drug delivery and targeting, their current applications and potential future developments, including:</div>
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*Methods to optimize therapeutic efficacy, and the related commercial implications</div>
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*Difficulties with drug absorption, unwanted distribution and premature inactivation / elimination</div>
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*Attempts to minimize toxicity or alter immunogenicity</div>
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*Methods to achieve rate-controlled drug release and effective drug targeting</div>
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*Novel and established routes of delivery </div>
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*Use of new generation technologies such as biosensors, microchips, stimuli-sensitive hydrogels and plasmid-based gene therapy</div>
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This volume is indispensable for pharmaceutical students, scientists and researchers.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-33658926274101953322013-12-13T23:41:00.002-08:002023-06-26T03:11:18.272-07:00Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products (Volume 4 of 6)<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://2.bp.blogspot.com/-JzszmU3lJQk/UqwLIC3mxaI/AAAAAAAATR8/5oGqNLBrCIs/s1600/formu.png" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://2.bp.blogspot.com/-JzszmU3lJQk/UqwLIC3mxaI/AAAAAAAATR8/5oGqNLBrCIs/s1600/formu.png" width="242" /></a></div>
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The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and the BASF book of generic formulations. Each entry begins with a fully validated scaleable manufacturing formula that includes compendial specification requirement for each ingredient, in-process controls for manufacturing and release of product, a summary of manufacturing process, and details of packaging.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-64452971393505796962013-12-13T23:22:00.001-08:002023-06-26T03:12:01.980-07:00Handbook Of Pharmaceutical Excipients, By Raymond C Rowe And Paul J Sheskey<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-HZDAsTfL9KE/UqwF8P1ycyI/AAAAAAAATRs/A72tq8vqAdw/s1600/pharexp.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://1.bp.blogspot.com/-HZDAsTfL9KE/UqwF8P1ycyI/AAAAAAAATRs/A72tq8vqAdw/s1600/pharexp.jpg" width="248" /></a></div>
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Pharmaceutical dosage forms contain both pharmacologically active compounds and excipients added to aid the formulation and manufacture of the subsequent dosage form for administration to patients. Indeed, the properties of the final dosage form (i.e. its bioavailability and stability) are, for the most part, highly dependent on the excipients chosen, their concentration and interaction with both the active compound and each other.</div>
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No longer can excipients be regarded simply as inert or inactive ingredients, and a detailed knowledge not only of the physical and chemical properties but also of the safety, handling and regulatory status of these materials is essential for formulators throughout the world. In addition, the growth of novel forms of delivery has resulted in an increase in the number of the excipients being used and suppliers of excipients have developed novel excipient mixtures and new physical forms to improve their properties. The Handbook of Pharmaceutical Excipients has been conceived as a systematic, comprehensive resource of information on all of these topics</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-35471155892492666792013-12-13T23:07:00.003-08:002023-06-26T03:14:31.180-07:00Pharmaceutical Preformulation And Formulation, By Mark Gibson<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-IZ9d2KYs4S4/UqwB76cenSI/AAAAAAAATRg/LkW9dLnFBNM/s1600/prepharma.png" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://1.bp.blogspot.com/-IZ9d2KYs4S4/UqwB76cenSI/AAAAAAAATRg/LkW9dLnFBNM/s1600/prepharma.png" width="221" /></a></div>
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This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry. Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses: candidate drug selection drug discovery and development preformulation predictions and drug selections product design to commercial dosage form biopharmaceutical support in formulation development and more.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-14117502247259867132013-12-13T22:51:00.002-08:002023-06-26T03:32:29.041-07:00Advanced Pharmaceutics: Physicochemical Principles<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://3.bp.blogspot.com/-1lNrHbHz3Dk/Uqv_EGpsAwI/AAAAAAAATRU/P4zmUXhhSpU/s1600/advance.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://3.bp.blogspot.com/-1lNrHbHz3Dk/Uqv_EGpsAwI/AAAAAAAATRU/P4zmUXhhSpU/s1600/advance.jpg" width="204" /></a></div>
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Discussing a comprehensive range of topics, Advanced Pharmaceutics: Physicochemical Principles reviews all aspects of physical pharmacy. The book explains the basic, mechanistic, and quantitative interpretation skills needed to solve physical pharmacy related problems. The author supplies a strong fundamental background and extensively covers thermodynamics, ionic equilibria, solutions and distribution, surface chemistry and colloids, kinetics, diffusion, and polymer science. </div>
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He outlines the latest research on diffusion through a membrane and the use of polymers in dosage forms.Packed with formulae and models, the book demonstrates the development of each and then describes the use of those models for a variety of formulation situations. The author's detailed explanation of the evolution of the formulae provides a clear understanding of when and how they are used. This bottom-up approach delineates the evolution of the formulae and gives a clear understanding of when and how they should be used. The book provides an in-depth review and analysis of dosage form design criteria that you can rapidly implement in your day-to-day work.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-8504015101915959612013-12-13T22:30:00.002-08:002023-06-26T03:11:43.065-07:00Modern Pharmaceutics Fourth Edition<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-JY_FCm_rwYw/Uqv546Q32AI/AAAAAAAATRE/HtUne1uhhfg/s1600/mpharma.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="http://1.bp.blogspot.com/-JY_FCm_rwYw/Uqv546Q32AI/AAAAAAAATRE/HtUne1uhhfg/s1600/mpharma.jpg" /></a></div>
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"Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration."</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-35990293713202108562013-12-13T22:14:00.003-08:002023-06-26T03:45:21.038-07:00Active Pharmaceutical Ingredients Development, Manufacturing And Regulation, By Stanley H. Nusim<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://3.bp.blogspot.com/-JYOSi_rMJZg/Uqvy_m2XRVI/AAAAAAAATQ0/nJevP8GE6lk/s1600/api.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://3.bp.blogspot.com/-JYOSi_rMJZg/Uqvy_m2XRVI/AAAAAAAATQ0/nJevP8GE6lk/s1600/api.jpg" width="210" /></a></div>
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Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-86055938930713243792013-12-12T23:43:00.004-08:002023-06-26T03:45:43.465-07:00Remington: The Science and Practice of Pharmacy [PDF]<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-SIwbuS75jGU/UqqXgRuDXkI/AAAAAAAATQE/YlsUDzfRHQE/s1600/remm.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="http://1.bp.blogspot.com/-SIwbuS75jGU/UqqXgRuDXkI/AAAAAAAATQE/YlsUDzfRHQE/s1600/remm.jpg" /></a></div>
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For over 100 years, Remington has been the definitive textbook and reference on the science and practice of pharmacy. This Twenty-First Edition keeps pace with recent changes in the pharmacy curriculum and professional pharmacy practice.</div>
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More than 95 new contributors and 5 new section editors provide fresh perspectives on the field. New chapters include pharmacogenomics, application of ethical principles to practice dilemmas, technology and automation, professional communication, medication errors, re-engineering pharmacy practice, management of special risk medicines, specialization in pharmacy practice, disease state management, emergency patient care, and wound care.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-71631511690933417722013-12-12T01:56:00.002-08:002023-06-26T04:02:47.214-07:00A Textbook Of Pharmaceutical Analysis, 3rd Edition<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://4.bp.blogspot.com/-zBDBUngBT30/UqmHmndmgkI/AAAAAAAATPI/lyEO97lMl38/s1600/kenneth.JPG" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://4.bp.blogspot.com/-zBDBUngBT30/UqmHmndmgkI/AAAAAAAATPI/lyEO97lMl38/s1600/kenneth.JPG" width="205" /></a></div>
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This book is a detailed, systematic treatment of analytically chemistry, focusing on drug analysis. It covers both classical techniques and modern approaches. It includes new sections on immunoassay, derivative formation, and statistical interpretation of data. Also includes an expanded treatment of liquid chromatography, as well as over 250 problems, many with solutions provided.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-66149757104242929002013-12-12T00:33:00.002-08:002023-06-26T03:14:01.144-07:00Martindale: The Complete Drug Reference, 36th Edition<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://3.bp.blogspot.com/-WxC4uiLI7yc/Uqly-MgmkmI/AAAAAAAATO4/iz-iy5xND9w/s1600/Martind.JPG" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://3.bp.blogspot.com/-WxC4uiLI7yc/Uqly-MgmkmI/AAAAAAAATO4/iz-iy5xND9w/s1600/Martind.JPG" width="211" /></a></div>
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This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-64575377460446289622013-12-10T23:37:00.002-08:002023-06-26T03:46:29.536-07:00Latest ICH Guidelines<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-PprTMyrvYUE/UqgMKnC-irI/AAAAAAAATN4/bACjjHbyFqI/s1600/32822c2423.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="http://1.bp.blogspot.com/-PprTMyrvYUE/UqgMKnC-irI/AAAAAAAATN4/bACjjHbyFqI/s1600/32822c2423.jpg" /></a></div>
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The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.</div>
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<b>Quality Guidelines:</b></div>
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Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.</div>
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<b>Safety Guidelines:</b></div>
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ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.</div>
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The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.</div>
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<b>Multidisciplinary Guidelines:</b></div>
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Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-65638930294109089952013-12-10T01:14:00.003-08:002023-06-26T03:35:29.284-07:00British Pharmacopoeia 2013<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://2.bp.blogspot.com/-VfW1ksjQ3qM/UqbK3Rh47wI/AAAAAAAATNI/Gs5Vk2rYLtM/s1600/bpbpbp.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://2.bp.blogspot.com/-VfW1ksjQ3qM/UqbK3Rh47wI/AAAAAAAATNI/Gs5Vk2rYLtM/s1600/bpbpbp.jpg" width="320" /></a></div>
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The British Pharmacopoeia (BP) 2013 is the leading collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.</div>
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<b>Global standards</b></div>
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Now used in over 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture and testing around the globe.</div>
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<b>Flexible access options</b></div>
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The BP 2013 package comprises five volumes of the British Pharmacopoeia 2013 and a single volume of the British Pharmacopoeia (Veterinary) 2013, along with a fully searchable CD-ROM and online access to provide you with flexible resources.</div>
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<b>New for 2013</b></div>
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Legally effective from 1 January 2013</div>
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41 new BP monographs</div>
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40 new European Pharmacopoeia monographs</div>
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619 amended monographs</div>
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6 new and 1 amended Infrared Reference Spectra</div>
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European Pharmacopoeia 7th edition material up to and including Supplement 7.5</div>
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Free in-year updates in January, April and July to harmonise with the European Pharmacopoeia</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-86336278078175273982013-12-09T23:36:00.003-08:002023-06-26T03:20:55.953-07:00Indian Pharmacopoeia 2010 [ 3 Volume Set - PDF ]<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://1.bp.blogspot.com/-vI0YQKte0ZQ/UqaxC_QMM8I/AAAAAAAATMo/-kTC81fatrs/s1600/IP2010.jpg" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="http://1.bp.blogspot.com/-vI0YQKte0ZQ/UqaxC_QMM8I/AAAAAAAATMo/-kTC81fatrs/s1600/IP2010.jpg" width="240" /></a></div>
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The 6th edition of the Indian Pharmacopoeia 2010 is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a plan and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about two years. It supersedes the 2007 edition but any monograph of the earlier edition that does not figure in this edition continues to be official as stipulated in the Second Schedule of the Drugs and Cosmetics Act, 1940. This edition would be effective from 1st September, 2010.</div>
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The Indian Pharmacopoeia 2010 is presented in three volumes. Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction, and the General Chapters. Volume II contains the General Notice, General Monographs on Dosage Forms, Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume III contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by Monographs on Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary products.</div>
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The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition. The number of monographs of Excipients, Anticancer drugs, Herbal products and Antiretroviral drugs have been increased in this edition. Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. A chapter on NMR is incorporated in Appendices. The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international requirements.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-71841700163444132062013-12-09T21:58:00.003-08:002023-06-26T03:42:06.753-07:00Medicinal Chemistry - By Ashutosh Kar<div dir="ltr" style="text-align: left;" trbidi="on">
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This is the forth edition of a book written to serve both as a useful textbook for undergraduate courses in medicine and pharmacology, and also as a handy reference title for industry professionals. Each of the 27 chapters is sub-divided into 3 sections: </div>
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(i) an introduction to the subject, </div>
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(ii) a chemical or pharmacological classification -– each category of compound importantly contains International Non-proprietory Names (INN), British Approved Names (BAN) and United States Approved Names (USAN) wherever applicable, chemical names and proprietory names. </div>
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(iii) the synthesis of various important members treated individually, a brief description of the synthesis, therapeutic applications of each compound, the necessary dosage applied in various diseases, and routes of administration. </div>
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The book also deals well with the comprehensive mechanism of actions of the structure -– activity -– relationships (SARs); thus aiding the students’ understanding. Clearly written, well referenced and fully up to date with recommended readings and self assessment questions, Prof. Kar has provided an accessible text book for students of medicinal chemistry. </div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1178172959142115757.post-6210952178274571332013-12-04T21:57:00.002-08:002013-12-04T21:57:45.242-08:00Boronic Acids: Preparation and Applications in Organic Synthesis and Medicine<div dir="ltr" style="text-align: left;" trbidi="on">
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For the first time, the whole field of organoboronic acids is presented in one comprehensive handbook.</div>
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Professor Dennis Hall, a rising star within the community, covers all aspects of this important substance class, including applications in chemistry, biology and medicine.</div>
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Starting with an introduction to the structure, properties, and preparation of boronic acid derivatives, together with an overview of their reactions and applications, the book goes on to look at metal-catalyzed borylation of alkanes and arenas, coupling reactions and rhodium-catalyzed additions of boronic acids to alkenes and carbonyl compounds. There follows chapters on copper-promoted C-O and C-N cross-coupling of boronic acids, recent applications in organic synthesis, as well as alpha-haloalkylboronic esters in asymmetric synthesis. Later sections deal with cycloadditions, organoboronic acids, oxazaborolidines as asymmetric inducers, and boronic acid based receptors and sensors. The whole is rounded off with experimental procedures, making this invaluable reading for organic, catalytic and medicinal chemists, as well as those working in organometallics.</div>
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<b><a href="http://rapidshare.com/share/785E2C758DA6B1A860875D99C2311EBD" target="_blank">Download</a></b></div>
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