Showing posts with label Pharmaceutical Magazines. Show all posts
Showing posts with label Pharmaceutical Magazines. Show all posts
Express Pharma Digital Issue August 2025 - Revolutions In Injectables
IN THIS ISSUE COVER STORY
Revolutions In Injectables
EDITOR'S NOTE
Walking the talk on ESG, workplace safety
INTERVIEW
Dr Satish Wagh, Chairman, CHEMEXCIL, and founder, Supriya Lifescience
MARKET
Startups: India’s next big bet on pharma innovation?
Pretty risky: India's wellness boom and the missing rulebook
TECHNOLOGY
Digital twins: Revolutionizing vaccine trial site procurement in developing countries
STRATEGY
How patient suites are reshaping the future of clinical trials
RESEARCH
Can stem cell therapy cure diabetes?
POST EVENT
IIHMR University's annual convocation 2025 felicitates 423 graduates, highlights global recognition and academic excellence
Clinical Pharmacology & Therapeutics Journal ~ Volume 85, Issue 5, May 2009
This issue discusses drug delivery and how advances in the pharmaceutical sciences and other scientific fields have enabled substantial progress in this field. Targeting the best route or providing a variety of routes of drug administration presents an array of benefits, such as enhanced drug administration and bioavailability, improved patient acceptance and compliance, decreased toxicity, and precise therapeutic targeting. Technologies enabling drug delivery are now commonly used to create and extend markets, and the pharmaceutical industry is turning to drug delivery to extend the revenueearning lifetime of their biggest products. Growth opportunities for drug delivery systems extend into all therapeutic classes of pharmaceuticals and encompass a wide range of compounds and formulations, presenting many options in the world market. The discovery of better delivery systems in conjunction with the discovery of novel pharmacological compounds will advance disease diagnosis and treatment.
In This Issue
Top of pageRegulating combination products
The US Food and Drug Administration (FDA) guidance on medical devices ensures the safety, efficacy, and security of drugs released to the public. The introduction of combination products has convoluted the approach historically used by the FDA to regulate single-entity products. Lauritsen details the complications faced by the agency in regulating combination products and the most important issues that must be addressed. See page 468
Top of pageAppraising the safety and efficacy of drug-eluting stents
The use of drug-eluting stents (DESs) in procedures has significantly increased worldwide since their approval by the US Food and Drug Administration in 2003. Although DESs are considered superior to bare-metal stents, safety concerns remain in the wake of reports of late stent thrombosis and myocardial infarction. In response to these concerns, new-generation DESs have been approved and made available for use. Using published clinical data, Maluenda et al. appraise the safety and efficacy of several DESs. See page 474
Top of pageEffect of multiple alleles on efavirenz disposition
Efavirenz (EVF), a non-nucleoside reverse transcriptase inhibitor used for treatment of HIV-1 infection, is primarily metabolized by CYP2B6. Although CYP3A4/3A5 has also been associated with higher EVF exposure, the influence of CYP2A6 polymorphism on EVF pharmacokinetics has not yet been determined. Arab-Alameddine et al. discuss the impact of multiple alleles on EVF disposition. See page 485
Top of pageThe growing role of nanoparticles in brain tumor diagnosis and therapy
Nanoparticle-based contrast agents designed for use in diagnosing brain tumors using magnetic resonance imaging (MRI) are capable of providing better information on the extent of tumor. The potential to visualize portions of tumors usually not detectable with conventional MRI makes nanoparticles of interest for advancing the diagnosis, operative management, and adjuvant therapy of brain tumors. Orringer et al. discuss the application of nanoparticles to brain tumor diagnosis and therapy and the many reasons that nanoparticles offer the next frontier in the treatment of brain tumors. See page 531
Top of pageBiologics in cardiovascular regenerative medicine
Stem cell–based cardiovascular regenerative medicine plays an integral role in therapy aimed at achieving structural and functional repair of the myocardium. Although experience gained in the clinical setting has shown stem cell–based cardiovascular regenerative medicine to be feasible and safe, the structural and functional benefits of such therapy have not yet reached their full potential. The very low rate of cell retention by the recipient myocardial tissue justifies review of the accumulated data to guide future developments aimed at overcoming this limitation and achieving a better outcome of stem cell delivery. See page 548
Powder and Bulk Engineering International, May 2009
Powder and Bulk Engineering International [ISSN 1098-6480] is published six times a year in January, March, May, July, September, and November by CSC Publishing, Inc., 1155 Northland Drive, St. Paul, MN 55120 USA.
TOC:
TRADE SHOW PREVIEWS:
NPE2009 preview
MIXING AND BLENDING:
Selecting the correct mixer Carl Ewing
Glossary of mixing and blending terms
Equipment feature: Mixing and blending
ENGINEERING LITERATURE:
Bin level indicators
PARTICLE ANALYSIS:
Combining size and shape analyses for more precise particle characterization Nicolas Marchet
Equipment feature: Particle analysis
CONVEYING:
Aero conveyor: Gentle conveying for friable materials Nick Hayes
DEPARTMENTS:
Guest editorial
Industry news
Supplier notes
Events
Advertiser index
Product update
Chemical Engineering Magazine - April 2009
COVER STORY
34Cover Story Achema Defies Economic Odds Even in a recession year, over 180,000 visitors from 100 countries are anticipated at this triennial event
NEWS
13Chementator This new crystallizer reduced damage to larger crystals; Sonopolymerization as a means to manufacture composite nanoparticles; Reduce process consumables with this new separator; A less expensive way to make conductive coatings; A new standard for viscosity measurement; High-throughput screening accelerates glycerolto-chemicals research; A palladium catalyst makes primary amines in aqueous NH3; Optical fiber sensing gets an NSF boost; EPA proposes national reporting system for greenhouse gases; and more
24Newsfront Recycling Cathode Ray Tubes As CRTs become an obsolete form of video display technology, recycling their lead-filed glass is increasingly important
28Newsfront Digital Handover Headaches Electronic project handover has helped, but standardization with data and system compatibility remain
ENGINEERING
37Facts At Your Fingertips Energy Efficiency In Steam Systems This one-page guide explains the importance of efficient condensate handling in steam systems
42Feature Report Optimizing Pumping Systems Often overlooked, pump system efficiency makes a dramatic impact on process performance
46Feature Report Calculate Capital Costs Quickly Estimating capital costs early can prevent wasting money on dead-end projects
53Solids Processing Understanding Bends In Pneumatic Conveying Systems Despite their apparent simplicity, bends are often poorly understood and unless properly designed, they are potentially problematic
EQUIPMENT & SERVICES
40D-1, 40I-1Show Preview Achema Achema 2009 (Frankfurt am Main, Germany; May 11–15), the World’s largest assembly of chemical process industry professionals is approaching. With over 200,000 visitors and more than 3,500 exhibitors filling the exhibition grounds of Messe Frankfurt GmbH, this exhibition and congress on chemical engineering, environmental protection and biotechnology continues to be the flagship trade fair for the chemical process industries. This show preview contains a cross-section of the products and services that will be on display
61Focus Temperature Measurement & Control This three-way valve improves temperature control; Field-ready portable temperature monitor features three scales; Get industrial boiler measurements for consistent blowdown control; This module delivers a wide range of capabilities for temperature control; Measure flowrate and temperature with one instrument; New infrared sensor offers improved performance in harsh industrial environments; and more
COMMENTARY
5Editor’s Page Achema maintains influence This month, instead of focusing on a single comprehensive story or even a two-part series, our cover highlights Achema 2009, an important thread that weaves throughout the issue and beyond.
COMING IN MAY
Look for: Feature Reports on Design and Operation of Gravity Dryers; and Chemical Process Safety; Engineering Practice articles on Optimal Cooling Systems for Coastal Plants; ERP Packaging for Your EPC Contracting Business; and Treatment of Wastewater in a Delayed Coking Unit; A Focus on Heat Transfer; News articles on Batch Processing; and Petroleum Refining; Facts at Your Fingertips on Process Control; and more
Pharmaceutical Engineering - Jan/Feb 2009
Articles:
- Fundamentals of Bacterial Adhesion Applied Toward Infection Prevention: Focus on Two Case Studies
- ISPE Update
- Classified Advertising
- Advertiser’s Index
- Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management Using Visible Residue Limits for Cleaning
- Industry Interview Series: Senior Staff Members from China’s State Food and Drug Administration (SFDA)
- Beyond the Bell Curve: A Report on Managing Capital Project Risk
Quality Progress - June 2008
Far-SightedIn the first year nonprofit organizations could apply for the honor, Coral Springs became the first local government to take home a Baldrige award by proving it didn't emphasize the present at the expense of the future....
Customer Servicemen
Customer Feedback is a key component of improvement. The challenge has always been finding the most effective way of procuring it....
Incredible Journey
In response to personnel’s safety concerns and rising workers’ compensation costs, a team at Boeing’s C-17 site developed a solution to thwart injury and save money....
Two Are Better Than One
Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....
The True Test of Loyalty
The customer loyalty field has experienced much technological innovation, such as automated reporting portals and integration of attitudinal and behavioral data in customer relationship management applications, over the past decade....
Who's Keeping Score?
There’s one tool you won’t find for sale at Sears. One of the retail giant’s divisions has started using a quality management tool extensively to maintain and improve its own quality management system....
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Quality Progress - February 2008
Sharpen Your Auditing SkillsEffective audits require effective audit planning. One of the best tools to help guide both the planning and execution of an audit is the audit checklist....
Efficiency Gets a New Identity
This article demonstrates the impact RFID will have on existing supply chain processes and the improvements RFID implementation will bring by comparing the benefits of RFID with those of barcode for various supply chain entities. The increases in data cap..
Educating Engineers
Statistics is an indispensable tool for solving engineering problems. But many engineers are not exposed to problems that require the use of statistical methods until they start their professional careers....
Good Vibrations
Modern quality management principles define quality as customer satisfaction with product and service. SCGC has a web page where guitar owners can have questions about their guitars answered by Hoover or Roberts. With employee empowerment accompanying goo...
Launch to Quality
After using different quality methods with limited success, the Naval Surface Warfare Center, Indian Head Division, implemented lean Six Sigma in 2004. Through all of this, leadership demonstrated a steadfast commitment to fully implementing lean Six Sigm...
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Quality Progress - March 2008
A Framework for Business EthicsProfit maximization is, of course, the main and foremost objective for any commercial organization. Most modern organizations realize that to survive in today’s competitive arena, customers have to be satisfied....
A Gold Medal Solution
Additionally, the production team's performance wasn't meeting its organizational goals—including quality, timeliness, efficiency and cycle time—for continuous improvement. Internal stakeholders included those from in-plant manufacturing, safety, and prod...
The Remedy for a Data Dilemma
In 1994, Bellin Health volunteered for a pilot assessment managed jointly by the Baldrige National Quality Program and the Joint Commission. This assessment helped Bellin focus on developing an integrated measurement system....
Strong Foundation, Solid Future
In the wake of the scandals five years ago that shook consumer confidence in business leaders and the economy, I co-wrote an article about the resurgence of social responsibility on the corporate landscape and increased public awareness on the topic....
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Controlled Environments - November 2008
BIOLOGICAL SAFETY CABINETS: CONTROLLING CONTAMINATION David Phillips 16 ACHIEVING TRUE EH&S IN CONTROLLED ENVIRONMENTS
Matt Kopecky
CLEANROOM FACILITY CONSTRUCTION OPTIONS
REGULATORY FORUM:
PREDICTING THE FUTURE
Bikash Chatterjee
CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM
THINKING OUTSIDE THE BOX (OR AT LEAST OUTSIDE THE SEM)
Barbara Kanegsberg and Ed Kanegsberg
C4: CRITICAL CLEANING FOR CONTAMINATION CONTROL
MAYBE HEISENBERG WAS WRONG, AND EINSTEIN RIGHT?
John Durkee, Ph.D., P.E 9 EDITOR’S LETTER 25 PRODUCT FOCUS:
INSTRUMENTATION
BUSINESS MARKETPLACE
PENCIL IT IN
ADVERTISER INDEX
CleanRooms - Magazines (Jan 08 to Oct 08)
Magazine of contamination control and clean manufacturing for clean room professionals in the semiconductor, biotechnology, life sciences, and cosmetic manufacturing.The entire package of the year 2008 from January to September.
Regulatory Focus - September 2008
Where is our profession headed?
A Seat at the Table:
Managing Global Business Risk:
Mergers, Acquisitions and Operational Risk
The Regulatory Professional:A Jack of All Trades
Regulating Nanotechnology in the US & EU
Powder and Bulk Engineering International Sep/Oct-2008
Powder and Bulk Engineering International [ISSN 1098-6480] is pub -lished six times a year in January, March, May, July, September, and November by CSC Publishing, Inc., 1155 Northland Drive, St. Paul, MN 55120. After several years of not being published, Powder and Bulk Engineering International is back! ARTICLES:
Basic criteria for selecting a bagging system Walter Kersting
Case History: FFS bagging adds flexibility at feed plant
Case History: Conveyor dryers increase capacity, ensure quality at
Thai Luxe
A preview of new products on display at POWTECH 2008
POWTECH 2008 exhibitor list
DEPARTMENTS:
Industry news
Engineering literature: Bin Dischargers
Equipment feature: Bagging and Packaging
Equipment feature: Drying
Engineering literature: Rotary Airlocks
Product update
Supplier news
People news
Events
Advertiser index
Pharmaceutical Engineering - July/August 2008
Table of Contents: Articles Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process
by Kurt Yanagimachi, Corey Dodge, and Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
Case Study: Parenteral Facility Upgrade Project with Fill Line Install
by Keith Weseli and Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
Retrofitting CIP into API Plants
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, and Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.
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by Kurt Yanagimachi, Corey Dodge, and Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
Case Study: Parenteral Facility Upgrade Project with Fill Line Install
by Keith Weseli and Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
Retrofitting CIP into API Plants
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, and Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.
Download
Pharmaceutical Engineering - May/June 2008
Table of ContentsArticles
A Risk-Based Approach to Cleaning Validation using Visible Residue Limits
by Richard J. Forsyth and Jeffrey L. Hartman
This article describes the development of a Visible Residue Limits (VRL) program in a pharmaceutical manufacturing facility, including sample and viewing parameters. Opportunities for VRL implementation were identified in both pilot plant and manufacturing settings.
GAMP 5 Quality Risk Management Approach
by Kevin C. Martin and Dr. Arthur (Randy) Perez
This article describes how the GAMP 5 quality risk management strategy offers a pragmatic approach to computer systems compliance.
Creating Quality by Design/Process Analytical Technology (QbD/PAT) Management Awareness
by Christian Woelbeling and the Regional PAT COP from ISPE DACH Affiliate
This article summarizes the first four chapters of the PAT awareness document created by the PAT COP and explains how QbD/PAT management awareness can be created.
Industry Interview Series: Ruediger Dorn, Managing Director, Worldwide Pharmaceutical Industry, Microsoft
In this interview, Ruediger Dorn discusses Microsoft’s focus on the life sciences and the evolving relationship between plant operations and IT. Speaking from experience in auto manufacturing, he gives his thoughts on current challenges in the pharmaceutical industry.
Domain Methodology for Computer System Specification and Verification Applied to Manufacturing Execution Systems (MES)
by Joseph F. deSpautz and Gregory Ruklic
This article summarizes the domain methodology described in the GAMP® Good Practice Guide on Manufacturing Execution Systems currently under development.
Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System
by Gamal Amer
This article identifies ways to mitigate the risk associated with the manufacture of drug products.
On-line Exclusive Articles
Barrier Isolation History and Trends – 2006 Data
by Jack Lysfjord and Michael Porter
This article provides history and trends for automated fill finish for injectable drugs utilizing isolator technology.
GAMP 5 Debuts to a Record Breaking European Audience
by Gail Evans, ISPE Technical Documents Writer/Editor
Introduction to ICH: Essential Background to PQLI
by Dr. Kate E. McCormick, ISPE European Education Advisor
Global Regulatory News
Controlled Environments May 2008
Controlled Environments - a monthly magazine focused on clean room requirements for aspectic/sterile pharmaceutical & microelectronics manufacturing detailing latest developments in the technology, vista on the scientific background and much more.Download Link:
http://rapidshare.com/files/125318636/Cont_envir58.zip
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