International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs

International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs, Fifth Edition

Description:

This book contains the English language texts of all GMPs, regulations, guidelines, codes, and practices implemented by national and international regulatory authorities that govern the manufacture and testing of biotechnology-derived products, active pharmaceutical ingredients, and pharmaceuticals. Prepared with the cooperation of health authorities worldwide, this resource contains the GMPs in effect in 114 countries, plus GMP regulations of the World Health Organization, including the 1996 WHO GMPs, the European Union, the Association of South East Asian Nations, and the Pharmaceutical Inspection Convention.

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PART - 1

PART - 2

Significant Pharmaceuticals Reported in US Patents

Significant Pharmaceuticals Reported in US Patents
By Thomas F. DeRosa

Description:
This book identifies the next generation of pharmaceuticals reported in US Patents. This "hands-on" title provides explicit laboratory methods for preparing the most recent and effective medications. Each entry documents the biological testing protocols used to evaluate a drug and the significance of the current treatment agent over previous methods. Pharmaceuticals are included in this review only if at least two of the following criteria were met: Effectiveness in treating an illness, Innovative, ease of preparation, synergy with existing Medications.
Pharmaceuticals are reported for 27 separate classes of illness, including;
AIDS, Alzheimer's Disease, Cardiovascular Disorders, Diabetes, Epilepsy, Hepatitis C, Osteoporosis, Obesity and Sleep Disorders.
Significant Pharmaceuticals Reported in US Patents has been designed to be used as both a reference and synthetic guide for pharmaceutical, medicinal and organic chemists and graduate students.
Researchers working in other areas will also find the information valuable as in many instances intermediates or the next generation pharmaceutical are readily convertible into other industrial products including: anti-oxidants, chemical additives, herbicides, polymer precursors, water purification agents. Clear structural depictions of reagents and chemical transformations have been supplied to permit the identification of other future applications.

* Identifies next generation pharmaceuticals
* Provides practical preparation methods for each active agent and derivatives
* Documents the analytical characterization and biological testing results of active agents.

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Transport Processes in Pharmaceutical Systems

Transport Processes in Pharmaceutical Systems
By Gordon L. Amidon, Ping I. Lee, Elizabeth M. Topp

Description:

This cutting-edge reference clearly explains pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes, whole body kinetics, and drug release from polymer reservoirs and matrices to heat and mass transport in freeze-drying and hygroscopicity. Focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. Written by more than 30 international authorities in the field, Transport Processes in Pharmaceutical Systems · discusses the crucial relationship between the transport process and thermodynamic factors · analyzes the dynamics of diffusion at liquid-liquid, liquid-solid, and liquid-cultured cell interfaces · covers prodrug design for improving membrane transport · addresses the effects of external stimuli in altering some natural and synthetic polymer matrices · examines properties of hydrogels, including synthesis, swelling degree, swelling kinetics, permeability, biocompatibility, and biodegradability · presents mass transfer of drugs and pharmacokinetics based on mass balance descriptions · and more! Containing over 1000 references and more than 1100 equations, drawings, photographs, micrographs, and tables, Transport Processes in Pharmaceutical Systems is a must-read resource for research pharmacists, pharmaceutical scientists and chemists, chemical engineers, physical chemists, and upper-level undergraduate and graduate students in these disciplines.

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Cleanroom Technology: Fundamentals of Design, Testing and Operation

Cleanroom Technology: Fundamentals of Design, Testing and Operation
By W. Whyte

Description:

A cleanroom is a contamination-controlled environment and is essential in the industrial manufacture of many electronic, semiconductor, optical, pharmaceutical and medical products.

The use of cleanrooms for the manufacture of a large range of products such as microprocessors, CD players, lasers, pharmaceuticals and medical devices continues to grow and many companies are using cleanrooms for the first time. At the same time, new technology products that can only be produced in cleanrooms are being developed. This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with a introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards. Readers will benifit from the author's 35 years of experience in cleanroom technology R&D, consultancy and teaching. The text is complementary to the structure and content of Whyte's own and many in-house cleanroom courses in the electronics and pharmaceutical industries.
· Complementary to the highly successful Cleanroom Design, Second Edition and the forthcoming Cleanroom Testing and Running by the same author
· Presents the fundamentals and latest standards for the design, validation, testing and running of cleanroom systems
Pitched at introductory level and tailored to fulfil the training requirements of scientists and engineers new to cleanroom technology.

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Isolation Technology: A Practical Guide

Isolation Technology: A Practical Guide, Second Edition
By Tim Coles

Description:

The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: " Descriptions of and comments on new guidelines and standards " Technological advances - such as the new breed of sanitizing gas generators " Updates that reflect current thinking and new information Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.

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