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Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms
Presents an analysis of advances in aqueous-based polymeric coatings used around the world, providing coverage of coated dosage forms, film defects, and the characterization of polymers. The second edition offers information on biodegradeable and sillicone-based elastomer dispersions, the physical and mechanical properties of polymeric films, and more.Download
Ophthalmic Drug Delivery Systems, Second Edition
Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.Download
Herbal Medicines, 3rd Edition
Herbal medicinal products are increasing in popularity in the developed world although there are many concerns about their quality, safety and efficacy. "Herbal Medicines" provides a comprehensive single source of scientifically rigorous, impartial information on over 150 of the most commonly used herbal medicinal products. This third edition has been extensively revised and updated. It aims to answer the questions raised for the healthcare professional by providing scientifically rigorous, impartial information on medical herbs.Download
Dietary Supplements 3rd Edition
The use of dietary supplements has continued to increase steadily in recent years with, for example, 40 per cent of UK adults said to be taking such supplements on a regular basis. Although they are widely used, the use of dietary supplements is controversial in relation to their efficacy and safety and much recent research has been published considering these questions. This comprehensive new edition of "Dietary Supplements" has been completed revised and updated to include the latest findings on the most commonly used dietary supplements. This edition contains 82 regularly structured monographs with information on: uses, action, safety (adverse effects, pregnancy, interactions), efficacy, and dosage; full revised and updated with findings from the recent literature on common supplements such as: aloe vera, calcium, creatine, glucosamine, selenium, and vitamin C; includes 10 monographs new to this edition on: methylsulfonylmethane (MSM), nickel, pcynogenol, phytosterols, psyllium, quercetin, resveratrol, silicon, tin and vanadium; considers regulations relating to dietary supplements in UK, Europe and the USA; and useful appendices include a summary of interactions with conventional medicines.Download
Nutraceuticals: A Guide for Healthcare Professionals, 2nd edition
Nutraceuticals are complementary medicines of natural origin. Usually obtained from a food source, they are sold as isolated, purified components in pharmacological doses for specific ailments. The international market for nutraceuticals is rapidly expanding and new research is constantly being conducted. New products are appearing on the market, some with novel therapeutic applications. This new edition of "Nutraceuticals" reflects these changes and has broadened its scope and coverage. This authoritative text assesses the medical and scientific evidence for the use of nutraceuticals for prevention or treating important disease states. It will be of value to practicing pharmacists, other healthcare professionals and complementary medicine practitioners.Download
Homeopathic Prescribing Pocket Companion
This is a concise pocket book of clinical applications providing pharmacists with instant information for patients/customers.This concise pocket book offers all the basic information that a pharmacist will ever need regarding homeopathic remedies. Part one provides a general introduction on homoeopathy and the related disciplines of anthroposophy, Biochemic Salt and flower therapy. Part two includes decision tree prescribing flowcharts supported by supplementary information to assist in choosing the appropriate homeopathic medicine to treat a range of conditions. For the busy pharmacist who wants a useful hands-on pocket guide to homeopathy - this is the perfect book.Download
Pharmaceutical Compounding and Dispensing
This is a revision guide for students giving bullet points of basic information on pharmaceutical compounding and dispensing followed by questions and answers."Fast Track" is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Pharmaceutical Compounding and Dispensing", this book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing.A Fast Track website will also be live at time of publication and will include MCQs, sample online content and much more.Download[Updated]
Tablet And Capsule Machine Instrumentation
A guide to all aspects of tablet and capsule machine instrumentation in pharmaceutical research, development and production.In order to produce a satisfactory tablet or capsule it is necessary to combine a sound formulation with a proper control of the tabletting or capsule filling process. These considerations involve the need to make accurate measurements and this text provides a practical guide to the techniques and applications of instrumentation used to make these measurements.This text provides a sound understanding of the principles and techniques involved, and of how data generated by instrumented machines can be applied to problems in pharmaceutical research, development and manufacture.It encompasses major advances in instrumentation methodology as well as in both tablet presses and capsule filling equipment. In particular there are new methods of measurement, the feeding of the output of instrumentation into computers has become routine, and instrumentation techniques have been expanded to tablet press simulators, automatic press control and capsule filling equipment.Download [Updated]
Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance
Worldwide, there are varying Codes of Practice/Conduct for the pharmaceutical industry that ensure the industry self-regulates to promote the appropriate use of medicines by operating in a professional, ethical and transparent manner and ensuring high standards.The aim of this book is to aid the understanding of the many pharmaceutical Codes of Practice/Conduct throughout the world. It contains an overview of the guidelines for the promotion of pharmaceutical products in all geographical areas.Each section includes a "general overview" providing a discussion on that particular Code of Practice and differences/similarities with other countries.Download
Physical Pharmacy
This is a revision guide for students giving bullet points of basic information on physical pharmacy followed by questions and answers.Fast Track is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Physicochemical Principles of Pharmacy", this title is a concise guide providing the physicochemical background to the design and use of pharmaceutical dosage forms.Download
Handbook of Pharmaceutical Excipients, 5th edition
This is an excellent book that contains every phamaceutical excipient that I have ever had the need to know about. I work for a dietary supplement manufacturer and we quite often get calls from customers that want to know all about all those "other ingredients" that are listed on product cartons. The book has a section for each excipient and each excipient has the following sections: Nonproprietary Names, Synonyms, Chemical Name and CAS Registry Number, Empirical Formula and Molecular Weight, Structural Formula, Functional Category, Applications in Pharmaceutical Formulation or Technology, Description, Pharmacopeial Specifications, Typical Properties, stability and Storage Conditions, Incompatibilities, Method of Manufacture, Safety, Handling Precautions, Regulatory Status, Pharmacopeias, Related Substances, Comments, Specific References, General References, and Authors. While I have a background in Biology, I found several of the sections to be easy to understand by several of our employees that do not have a science background. While, still, there was highly technical/scientific information as well. Each excipient's information is contained in 2-4 pages. The book is arranged alphabetically which makes finding information easy. In addition, it contains an index that is very well constructed. For example: If you are looking for an Emulsifying Agent, the index lists all the excipients that can be used for that purpose. I can't say enough how easy this book is to use. Its information is pared down to the essential text, and is chocked full of graphs, charts and microscopic photos of the excipients.Download
Stockley's Drug Interactions, 8th Edition
First published over twenty years ago, "Stockley's Drug Interactions" is still the most indispensable and authoritative international source of drug interaction information. Based upon the many thousands of published clinical papers and reports, it provides a series of detailed yet concise monographs designed for quick and easy reference. Each monograph contains a summary, clinical evidence for the interaction under discussion, its probable mechanism, clinical importance and management. Individual interactions are assembled alphabetically into chapters, grouped therapeutically, pharmacologically or individually. Both Recommended International Nonproprietary Names (rINN) and US Adopted Names (USAN) are used throughout the book.Download
Clean-in-Place for Biopharmaceutical Processes
An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.Download
Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007: aka the Orange Guide
Familiarly known as the "Orange Guide," this title combines the major pharmaceutical Regulations, Directives and guidance, which wholesalers and the pharmaceutical industry use as their main source when manufacturing and distributing medicinal products in the EU.Download [UPDATED]
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.Download
Aerosols Handbook: Measurement, Dosimetry, and Health Effects
As more attention is dedicated to understanding the occupational health risks associated with the industrial manufacture and use of nanotechnology, Aerosols Handbook: Measurement, Dosimetry, and Health Effects is a timely presentation of the latest research in the field of aerosol science. The book covers a multitude of topics on indoor, outdoor, and industrial aerosols, including aerosol measurement, deposition, particle size distribution, and biokinetic processes. Where harmful exposure to ultrafine particles may occur through inhalation, dermal contact, and ingestion, this book discusses how the size, shape, and chemical properties of particles affect aerosol deposition in the lungs, possibly other organs, and the overall toxicity. The book covers all relevant aspects of aerosols, from epidemiology to molecular biology, and emphasizes the importance of accurate aerosol measurement. The authors discuss Chernobyl accident and miners' lungs in detail to illustrate the effects of radioactive aerosols. The final section focuses on the health effects of specific aerosols, such as diesel aerosols and ultrafine particles. By converging research from both radioactive and non-radioactive aerosols, the editors give the book a unique and more complete perspective of how aerosols behave in the lungs. Aerosols Handbook: Measurement, Dosimetry, and Health Effects is an essential resource for those who study exposure, dosages, and toxicity to develop treatments for exposure, reduce air pollution, and establish better safety regulations, particularly in industries using nanotechnologies.Download
Engineers Guide to Pharmaceuticals Production
Most of the significant developments of medicines have occurred in the last 70 years and by a process of trial and error many plants and other substances have been used by man to produce certain pharmalogical effects. This book is a general introduction aimed at all those involved in the engineering stages required for the manufacture of the active ingredient (drugs & primary manufacture) and its dosage forms (secondary manufacture). Chapters also focus on the design of quality control laboratories, process development facilities and pilot plants as these all play a role in ensuring medicines are of an appropriate quality and have their own special problems for pharmaceutical products.Download
Industrial Water Pollution Control
Theory-to-practice guide to controlling industrial water pollution. In a thoroughly updated new edition that reflects both more stringent regulations and the new technologies developed to meet them, Industrial Water Pollution Control, Third Edition, by W.Wesley Eckenfelder, Jr., introduces you to environmentally-acceptable and cost-effective. state-of- the art methodologies. After an overview of the source and characteristics of industrial wastewaters, you learn about pre- and primary treatment processes...coagulation, precipitation and metals removal...aeration and mass transfer...aerobic biological oxidation and other biological wastewater treatment processes...adsorption...ion exchange...chemical oxidation...sludge handling and disposal...and other processes, including deep-well disposal, membrane process, and more. Specific examples and case histories from a variety of industries, including pulp and paper, chemical and pharmaceutical, textile, food products, and metal finishing, help you understand the application of these technologies to real-world industrial wastewater treatment.Download
Water Properties of Food, Pharmaceutical, and Biological Materials
Unique and informative, Water Properties of Food, Pharmaceutical, and Biological Materials is based on lectures and papers given by leading international researchers at the 9thInternational Symposium of the Properties of Water in Foods (ISOPOW 9) that took place in September 2004. Each chapter presents an authoritative account of the latest research on the physical and chemical properties of water in relation to the stability of food, pharmaceutical, and biological materials.
The first part of the text focuses on presentations given by invited speakers, whereas the second part is dedicated to oral presentations and discussions. Topics include the role of water in structural and functional properties, preserving biomolecule functionality in restricted water environments, and micro- and nano- techniques used for assessing water-solid interactions in food and drug development.
This book is an invaluable resource that synthesizes cutting-edge information with innovativeviewpoints from internationally esteemed researchers who participated in ISOPOW 2004
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Pharmacokinetics in Drug Discovery and Development
Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference. After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.Download
Protein-Based Films and Coatings
This volume presents the most up-to-date and detailed information available on protein-based biopolymer films and coatings. It provides a comprehensive overview of the design, technology, properties, functionality, and applications of biopolymer films and coatings (edible and inedible) from plant and animal proteins. Both widely commercialized and envisioned applications of protein films are discussed, including hard and soft gelatin capsules, microcapsules, collagen casings, and meat and produce coatings. Expert contributors provide thorough reviews of related interdisciplinary research and extensive lists of references. About the Editor: Aristippos Gennadios, Ph.D. is Senior Manager, Materials Science and Clinical Supplies, Product Development: US and Canada, Banner Pharmacaps Inc. (a Sobel NV Company) in High Point, North Carolina. He received his B.S. in Chemical Engineering from the National Technical University in Athens, Greece, his M.S. in Agricultural Engineering from Clemson University, and his Ph.D. in Agricultural and Biological Systems Engineering from the University of Nebraska in Lincoln. Dr. Gennadios is also Adjunct Associate Professor in the Department of Biological Systems Engineering at the University of Nebraska in Lincoln. He has authored or co-authored over 40 refereed publications and has been granted 2 U.S. patents.Download
Pharmaceuticals in the Environment: Sources, Fate, Effects and Risks
The study of pharmaceuticals in the environment as an area of research has only just taken off in recent years. Since the first edition was printed, many research articles on this subject have been published. It is exceedingly difficult for the individual, in particular those not acquainted with the field to establish trends and developments. Even specialists will appreciate this book, as it provides the reader with a well-founded up dated and enlarged overview that addresses the latest findings on the new topics in research.Following the resounding success of the first two editions, this new edition has been brought up to date and greatly extended. It includes the status of research, paying particular attention to sources and contamination of the environment, substance flows, effects, risk assessment and risk management. In line with the newest developments worldwide there are again contributions from well known and new international authors. This volume also caters for the new requirements confronting European and American researchers since publication of the second edition.
Jobs in the Drug Industry: A Career Guide for Chemists
This book is intended to help newly graduated chemists, particularly organic chemists, at all levels from bachelors to post-doctorates, find careers in the North American pharmaceutical industry. It will serve as a practical, detailed guiedbook for job seekers as well a reference work for faculty advisers, research supervisors, development officers, employment agents, and personnel managers in the industry. The book gathers in a single volume the fundamentals of getting an industrial job as a medicinal or process chemist, and covers all aspects of a chemist's job--scientific, financial, and managerial--within a pharmaceutical/biotechnology company. Other scientists looking for jobs as analytical or physical chemists and even biochemists and biologists will find the book useful. The valuable appendix is a unique compendium of 365 commercial, governmental, or non-profit institutions that comprise the North American pharmaceutical industry.Key Features
* Learn How To:
* Discover the 12 permanent, big-pharma jobs for B.S. chemists
* Use the 500+ company index to locate potential employers
* Track pharma openings with 190+ corporate and chemist-specific job banks
* Add industry veterans to your employment network
* Find the 50+ companies offering paid summer internships to students
* Include the one resume item that wins interviews for B.S. and M.S. chemists
* Express a knowledgeable preference for drug discovery or development
* Research over 360 drug companies through their Web sites
* Discover the 70+ firms offering stock purchase plans or stock options¾and which two represent big pharma
* Find out your salary offer in time to negotiate your wages.
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Microbiology, Fifth Edition
Prescott, Harley and Klein's 5th edition provides a balanced, comprehensive introduction to all major areas of microbiology. Because of this balance, Microbiology, 5/e is appropriate for students preparing for careers in medicine, dentistry, nursing, and allied health, as well as research, teaching, and industry. Biology and chemistry are prerequisites. The Fifth Edition has been updated extensively to reflect the latest discoveries in the field.Download
Pharmaceutical Marketing: A Practical Guide
Designed as a practical guide for the pharmaceutical industry, Pharmaceutical Marketing applies cutting-edge marketing concepts and tools to the real-world intricacies of marketing a heavily regulated product whose success is determined not by the actual end-user, but by various industry stakeholders. From creating a worldwide vision that cascades into local tactics to managing a drug portfolio or pricing a particular product, this book guides readers through developing, implementing, and auditing a successful marketing strategy geared specifically to the pharmaceutical industry. It provides graphs, tables, worksheets, pharmaceutical case studies, and a sample marketing strategy.Download
Liposomes : Rasional Design
This up-to-date reference covers the basics of liposomology, offering insights from over 30 scientists involved in its growth and considering the direction of future developments. Describes the liposome patent portfolio developed over the last 30 years! Outlining the procedures that bring liposome pharmaceuticals from laboratory to clinic, Liposomes · discusses the design of clinical trials · analyzes morphological diversity and functionality in gene delivery · highlights antitumor activities of lipids acting as second messengers · suggests how antibodies to cholesterol can be used therapeutically · explores applications of liposomes with high captured volumes · details the clinical detection of antilipid antibodies · addresses the lyophilization of liposomes · and more! With over 1400 references, tables, drawings, and photographs, Liposomes is suitable for industrial, clinical, and research pharmacists; pharmacologists; research and development scientists in the pharmaceutical, food, cosmetic, veterinary, agricultural, and chemical industries; biochemists; industrial, medicinal, organic, and pharmaceutical chemists; biophysicists; biotechnologists; microbiologists; molecular and cell biologists; and graduate students in these disciplines.Download
The Pharmacopoeia of the United States of America: Facsimile of the First Edition (1820)
The Pharmacopoeia of the United States of America: (The United States Pharmacopoeia). By General Medical Convention, United States Pharmacopeial Convention Committee of Revision, United States Pharmacopœial Convention, General Convention for the Formation of the American Pharmacopoeia, National Convention for Revising the Pharmacopoeia Published by United States Pharmacopoeial Convention, Inc., 1820-1975., 1820Download
Essentials of Pharmacy Law
This book examines the laws and regulations relating to the practice of pharmacy, and the regulation and control of drugs cosmetics, and medical devices. Most available pharmacy law texts thus far have been written by lawyers and present heavy, dense, legalistic reading that focuses on legal theory. Essentials of Pharmacy Law is written by a practicing pharmacist in clear, accessible, contemporary prose that concentrates on application. This user-friendly text is a compilation and commentary of selected federal laws and regulations pertaining to the general practice of pharmacy in the United States. It covers topics in a simple and concise format. Furthermore, case studies and review questions and a bulleted summary of key points make for easy reading and aid in comprehension. Essentials of Pharmacy Law will be extremely useful to senior pharmacy students preparing for the Multi-State Jurisprudence Exam (NABLEX MJPE). as well as the voluntary Pharmacist Competency Exam offered to practicing pharmacists. It alsoalso serves as a valuable reference for pharmacy students, practicing pharmacists seeking licensure by reciprocity and/or preparing for the MJPE, pharmacy technicians who are in need of a comprehensive update, and other interested healthcare professionals.Download
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form
Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features.Download
Laboratory Auditing For Quality and Regulatory Compliance
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.Download
Handbook of Pharmaceutical Analysis by HPLC, Volume 6
High pressure liquid chromatography frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening,* A complete reference guide to HPLC
* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development
* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
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Cosmetic Formulation of Skin Care Products
Specifically written to meet the needs of the cosmetic chemist and engineer, this reference outlines the latest technologies and issues pertinent to the development novel skin care products including advances in formulation and development, raw materials and active ingredients, compound testing, and clinical assessment. Organized by product category, then by body application area, this guide supplies all one needs to know to create effective skin care products for men and women in a diverse range of ethnic populations.Download
Environmental Monitoring for Cleanrooms and Controlled Environments
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.Download
Calibration in the Pharmaceutical Laboratory
Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable tool when setting out SOPs for balances and scales used throughout the manufacturing and testing process.Download
Sterile Product Facility Design and Project Management, Second Edition
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.Download
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries,
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second EditionSpanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
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Burger's Medicinal Chemistry and Drug Discovery, 6 Volume Set
This new sixth edition of Burger's Medicinal Chemistry and Drug Discovery offers several new and unique features. For the first time, an online version of this major reference work will offer updated content from the print edition and easy access. For the first time, all volumes are structured entirely according to content and published simultaneously to provide broad coverage of medicinal chemistry and drug discovery for new or experienced medicinal chemists, biologists, pharmacologists and molecular biologists. This includes a current and global perspective of drug design, and drug development.With expanded content from 69 chapters to over 100 chapters, this sixth edition of Burger's Medicinal Chemistry and Drug Discovery includes more than 50ew material. An entire section has been dedicated to cancer research. Areas included are those at the foreground of life science including:
* Proteomics
* Genomics
* Bioinformatics
* Combinatorial Chemistry
* High-Throughput Screening
* Blood Substitutes
* Allosteric Effectors as Potential Drugs
* COX Inhibitors
* Statins
* High-Throughput Pharmacology
* and More.
The new sixth edition of Burger's Medicinal Chemistry and Drug Discovery is a Memorial Edition to Professor Alfred Burger who published this major reference work in the first edition as "Medicinal Chemistry" in two volumes in 1951. Dr. Burger's research focused on analgesics, antidepressants and chemotherapeutic agents. He is one of the few academicians to have a drug, designed and synthesized in his laboratories and brought to market. Dr. Burger's contribution to the fields of medicinal chemistry and drug discovery are well renowned and documented. He received the Louis Pasteur Medal of the Pasteur Institute and the American Chemical Society Smissman Award.
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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.
Testing Computers Systems for FDA/MHRA Compliance
There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.Download
Lehninger Principles of Biochemistry, Fourth Edition
This is a medium-sized heavyweight classic, updated, honest and useful for physicians. The authors do not make a fuss about the wealth of data available in biochemistry, keep a cool attitude overall and somehow manage to inspire lay readers. Physicians benefit from it a lot, since the dreaded detail of molecular pathology is described at an amazing level of medical awareness and even clinical relevance. Molecular models are clear enough for the busy practitioner who has little if any real interest in the arcane wireframes of those nevertheless current substances involved in prescriptions. The print is fine, and readable, the pagesetting is minimalist but useful, and the index is workable. As for the biochemical material, in the original text of Lehninger, everything has been carefully updated, in order not to spoil the reader with the usual Big Pharma nonsense. Incredible as it may sound this is an independent book even in the Age of Virtual News. Highly Reccommended. In conclusion, here we have a book we will not buy for the beauty of our reference desk, even in the age of the instant reference.Download
European Pharmacopoeia, 4th edition
The European Pharmacopoeia is a single reference work for the quality control of medicines in Europe. Several legal texts make the European Pharmacopoeia mandatory:A Convention on the Elaboration of a European Pharmacopoeia ratified in 2003 by 31 European countries and the European Union; European Union directives 2001/83/EC and 2001/82/EC,on medicines for human use and for veterinary use, respectively, maintain the mandatory character of European Pharmacopoeia specifications on medicines as regards their qualitative and quantitative composition and the tests to be carried out on these medicines, the raw materials used in production and the intermediates of synthesis. All producers of medicines or substances for pharmaceutical use therefore must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe. The texts of the European Pharmacopoeia are legally binding and compliance is enforced by the administrative or juridical authorities. The national authorities of the member states are bound to apply them if necessary replacing any national monograph on the same subject.The 4th Edition consists of an initial volume 2002 (4.0) and a collection of 8 non-cumulative supplements (4.1) published three times a year following the decisions of each session of the European Pharmacopoeia Commission. With supplement 4.6, the 4th Edition comprises 1750 specific monographs, 285 general methods illustrated by figures or chromatograms and 2140 reagents. Every 4 months a new volume enters into force.
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