Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
Pharma Books
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Monday, April 29, 2013
International Pharmaceutical Registration Book
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.
Guidebook for Drug Regulatory Submissions
Destined to become every regulatory director's essential desktop companion
professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.
Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.
Wednesday, April 17, 2013
BANKER and RHODES - Modern Pharmaceutics
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.
Monday, April 15, 2013
DOWNLOAD LACHMAN & LIEBERMAN - The Theory and Practice of Industrial Pharmacy
The Book is uploaded on a Google Server and unlike other File Hosting Sites, it will Never be Deleted or Removed or Fail to Download unless removed or deleted by the uploader Himself
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Sunday, April 14, 2013
Download Encyclopedia of Toxicology e-book (Second Edition).
The second edition of the Encyclopedia of Toxicology continues its comprehensive survey of toxicology. This new edition continues to present entries devoted to key concepts and specific chemicals. There has been an increase in entries devoted to international organizations and well-known toxic-related incidents such as Love Canal and Chernobyl. Along with the traditional scientifically based entries, new articles focus on the societal implications of toxicological knowledge including environmental crimes, chemical and biological warfare in ancient times, and a history of the U.S. environmental movement.
The Principle of Toxicology (Second Edition Edited By Phillip L. Williams, Rober C. James & Stephen M. Roberts.
The field of toxicology has grown enormously since Industrial Toxicology: Safety and Health Applications in the Workplace was first published in 1985. And while the original edition was hugely popular among occupational health professionals, the time is ripe to address toxic agents not only in the industrial setting but also in the environment at large. Renamed Principles of Toxicology: Environmental and Industrial Applications, this new edition provides health protection professionals as well as environmental scientists with precise, up-to-date, practical information on how to apply the science of toxicology in both the occupational and environmental setting. Through contributions from leading experts in diverse fields
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