Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

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Safety Pharmacology In Pharmaceutical Development And Approval

Providing detailed coverage of an emerging discipline within the pharmaceutical industry, Safety Pharmacology in Pharmaceutical Development and Approval lays out exactly the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery. The author addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.

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Good Laboratory Practice Regulations Vol 69

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation.

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Pharmaceutical Biotechnology

The textbook on Pharmaceutical Biotechnology provides comprehensively the fundamental concepts and principles in Biotechnology to expatiate and substantiate its numerous modern applications with regard to the spectacular development in the Pharmaceutical Industry. In a broader perspective, the students studying Biotechnology at undergraduate and postgraduate levels shall be grossly benefited by its well-planned systematically developed, structured, illustrated, expanded, elaborated, and profusely exemplified subject matter.It essentially comprise five major chapters, namely: Immunology and Immunological Preparations; Genetic Recombination; Antibiotics; Microbial Transformations; and Enzyme Immobilization. Besides, there are five auxiliary chapters, namely, Advent of Biotechnology; Biosensor Technology; Bioinformatics and Data Mining; Regulatory Issues in Biotechnology; and Safety in Biotechnology, which have been specifically included so as to stimulate the students, interest and broaden their horizon of knowledge and wisdom.The authors earnestly believe that the wide coverage of various topics mentioned above would certainly render Pharmaceutical Biotechnology to serve as an exclusive source of information`s, ideas, inspirations towards research, and finding newer possible practical solutions to problems encountered in the ever green pasture using knowledge of Biotechnology in the Pharmaceutical Industry. Contents Immunology and Immunological Preparations
Genetic Recombination
Microbial Transformations
Enzyme Immobilization
Advent of Biotechnology
Biosensor Technology
Bioinformatics and Data Mining
Regulatory Issues in Biotechnology
Safety in Biotechnology

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Advances in Chromatography, Volume 35

The rapidly expanding growth of the literature on chromatography, capillary electrophoresis, field flow fractionation, and other separation techniques makes it difficult for any individual to maintain a coherent view of progress in the field. Rather than attempt to read the avalanche of original research papers, investigators trying to preserve even a modest awareness of advances must rely upon authoritative surveys. Featuring reliable, up-to-the-minute reviews of major developments in chromatography and other separation techniques, this critically praised series separates the most important advances from an overabundance of supplementary materials.

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Impurities Evaluation of Pharmaceuticals

Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.

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Indoor Air Quality: A Guide for Facility Managers

Written in easy-to-understand, non-technical terms, this book can be both a ready reference and training guide. Covering each type of indoor air hazard, the author explains the basics of proper ventilation and the relationship of the HVAC system to indoor air quality. He examines fundamental procedures for maintaining good air quality, including filtration, control of humidity and moisture, and duct cleaning. A full chapter is devoted to recent developments and procedures for controlling toxic mold. Case studies, an HVAC glossary, and several helpful directories are also included. The guide provides a comprehensive account of indoor air quality hazards, their sources, and appropriate solutions.

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