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9780120455553

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In today's pharmaceutical industry, the analytical department plays a major role in the drug development process, providing accurate and precise data to support drug discovery, development, and market support. This handbook presents analytical research and development as a process-driven function assuring identity, safety, efficacy, purity, and quality of a product. Regulatory requirements and compliance are discussed as well as attempts to harmonize international regulatory authorities. Analytical techniques from the molecular to the bulk level, new drug discoveries, identification of impurities, various routes of administration, stability testing, and analytical documentation are all parts of the regulatory requirements during pre-approval inspections. This book is well referenced and indexed. Each of the 16 chapters is written by experts and illustrated with figures, tables, and graphs. Anyone involved with new drug development, production, and control in the pharmaceutical industry would fine this title useful as well as graduate students and faculty in these areas. This would be a good acquisition for a graduate or research chemical or pharmaceutical library. --E-Streams E-STREAMS Vol. 5, No. 6 - June 2002 On the whole this well written and thoroughly edited volume brings the reader up to date on a wide range of subjects pertaining to analytics in pharmaceutical industry. --Alexander Nezlin, CTS Chemical Industries Ltd, Kiryat Malachi, Israel

In today's pharmaceutical industry, the analytical department plays a major role in the drug development process, providing accurate and precise data to support drug discovery, development, and market support. This handbook presents analytical research and development as a process-driven function assuring identity, safety, efficacy, purity, and quality of a product. Regulatory requirements and compliance are discussed as well as attempts to harmonize international regulatory authorities. Analytical techniques from the molecular to the bulk level, new drug discoveries, identification of impurities, various routes of administration, stability testing, and analytical documentation are all parts of the regulatory requirements during pre-approval inspections.This book is well referenced and indexed. Each of the 16 chapters is written by experts and illustrated with figures, tables, and graphs. Anyone involved with new drug development, production, and control in the pharmaceutical industry would fine this title useful as well as graduate students and faculty in these areas. This would be a good acquisition for a graduate or research chemical or pharmaceutical library.--E-Streams E-STREAMS Vol. 5, No. 6 - June 2002On the whole this well written and thoroughly edited volume brings the reader up to date on a wide range of subjects pertaining to analytics in pharmaceutical industry.--Alexander Nezlin, CTS Chemical Industries Ltd, Kiryat Malachi, Israel

Author Information

Satinder Ahuja obtained his Ph.D. in analytical chemistry from the Philadelphia College of Pharmacy and Science. He serves as adjunct research professor at Pace University and is a consultant to pharmaceutical companies as president of Ahuja Consulting. Stephen Scypinski obtained his Ph.D. in analytical chemistry from Seton Hall University. He is director of analytical chemistry research and development department at R.W. Johnson Pharmaceutical Research Institute.

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