Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

• cGMP compliance
• pre-approval inspections
• stability and bioequivalence testing
• packaging commodity development
• common difficulties in formulating drugs
• changes to aNDAs

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Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

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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.

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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.

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Competition Law and Patents: A Follow-on Innovation Perspective in the Biopharmaceutical Industry

In June 2005 the European Commission announced that it had fined AstraZeneca €60 million for misusing the patent system to delay entry of competitors thereby abusing its dominant position in contravention of Art. 82 EC. In October 2005 a complaint by six phone manufacturers was reported against Qualcomm, a chip manufacturer that owns patents over technology used in 3G handsets, alleging that Qualcomm refused to license essential patents on fair terms, and charged excessive royalties for its essential patents thereby acting anti-competitively. In December 2005 the Commission published a Discussion Paper on the Application of Art. 82 to Exclusionary Abuses. In February 2007 the Commission opened an investigation into Boehringer’s best selling drug last year, Spiriva, in relation to possible misuses of the patent system to exclude competition from the market.

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http://rapidshare.com/files/131260102/Compet_law_paten.zip

Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk

In the last several years, business leaders, policymakers, and inventors have complained to the media and to Congress that today's patent system stifles innovation instead of fostering it. But like the infamous patent on the peanut butter and jelly sandwich, much of the cited evidence about the patent system is pure anecdote--making realistic policy formation difficult. Is the patent system fundamentally broken, or can it be fixed with a few modest reforms? Moving beyond rhetoric, Patent Failure provides the first authoritative and comprehensive look at the economic performance of patents in forty years. James Bessen and Michael Meurer ask whether patents work well as property rights, and, if not, what institutional and legal reforms are necessary to make the patent system more effective.

Patent Failure presents a wide range of empirical evidence from history, law, and economics. The book's findings are stark and conclusive. While patents do provide incentives to invest in research, development, and commercialization, for most businesses today, patents fail to provide predictable property rights. Instead, they produce costly disputes and excessive litigation that outweigh positive incentives. Only in some sectors, such as the pharmaceutical industry, do patents act as advertised, with their benefits outweighing the related costs.

By showing how the patent system has fallen short in providing predictable legal boundaries, Patent Failure serves as a call for change in institutions and laws. There are no simple solutions, but Bessen and Meurer's reform proposals need to be heard. The health and competitiveness of the nation's economy depend on it.

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http://rapidshare.com/files/127775918/Patent_failure.zip

International Pharmaceutical Registration

The increasing globalization of pharmaceutical markets and continuing consolidation within the pharmaceutical industry have highlighted the challenges of rapidly evolving regulatory requirements and created a much greater appreciation of the need for regulatory awareness throughout the industry. This book provides a practical overview and guide to the complexities of international pharmaceutical registration. With individual country chapters written by experts within that country drawn from regulatory authorities, international pharmaceutical companies, and regulatory consultants, the book comprehensively covers regulations across the globe.

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http://rapidshare.com/files/65008233/Inter_Pharma_Rreg.zip

Practical Guide to the Care of the Medical Patient

If you need a practical, portable resource to get you through your internal medicine clerkship or residency, this book is the answer! It zeroes right in on the differential diagnoses, clinical findings, lab values, and treatment guidelines you need to diagnose and manage more than 225 disorders, signs, and symptoms...and makes them easy to access quickly! This 7th Edition covers 53 new differential diagnoses and 37 new topics...includes more color dermatology images...and features a more compact format for increased portability and ease of use.

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http://rapidshare.com/files/62225986/Care_of_the_Medical_Patient.zip

The Handbook of Patient Safety Compliance: A Practical Guide for Health Care Organizations

Written for virtually every professional and leader in the health care field, as well as students who are preparing for careers in health services delivery, this book presents a framework for developing a patient safety program, shows how best to examine events that do occur, and reveals how to ensure that appropriate corrective and preventative actions are reviewed for effectiveness. The book covers a comprehensive selection of topics including

• The link between patient safety and legal and regulatory compliance
• The role of accreditation and standard-setting organizations in patient safety
• Failure modes and effect analysis
• Voluntary and regulatory oversight of medical error
• Evidence-based outcomes and standards of care
• Creation and preservation of reports, data, and device evidence in medical error situations
• Claims management when dealing with patient safety events
• Full disclosure
• Patient safety in human research
• Managing confidentiality in the face of litigation
• Managing patient safety compliance through accountability-based credentialing for health care professionals
• Planning for the future

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http://rapidshare.com/files/62199078/Patient_Safety_Compliance.zip

Filing Patents Online: A Professional Guide

Securing a patent through the traditional paper process is slow and expensive. Market demands and the worldwide migration to online patent application systems require attorneys and inventors alike to become familiar with Wweb-based filing. Pursuing patents via the Internet is quicker and more affordable, and makes good business sense. Unfortunately, existing online patent software is cumbersome and difficult to master, forcing many inventors and attorneys to rely on outdated, expensive methods. Filing Patents Online: A Professional Guide provides patent attorneys, inventors, and businesses with a step-by-step guide for filing and pursuing patents electronically. This comprehensive analysis of online patent systems from around the world recommends the proper choices for filers, saving time and money and increasing the odds of success. By following the hands-on examples of real filings contained in this book and its accompanying media kit, you can harness the power of the Internet to research, plan, and write winning claims. Filing Patents Online can result in thousands of dollars in savings and a secured patent that will keep a company ahead of the competition.

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http://rapidshare.com/files/54853938/Filing_Patents_Online.zip