Early Phase Drug Evaluation in Man

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John O'Grady, Otto I Linet
CRC Press, 2020 M02 3 - 737 pages
Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

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Contents

Organisation and Decision Making
97
Ethical and Legal Considerations
137
Measuring Drug Activity in Man
193
Assessment of Drug Effects on the Cardiovascular System ...
251
Assessment of Drug Effects on the Respiratory System ...
349
Assessment of Drug Effects on the Central Nervous System ...
377
Assessment of Drug Effects on the Gastrointestinal System ...
455
Assessment of Drug Effects on the Kidney
493
Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology ...
519
Assessment of Drug Activity in the Skin
551
Assessment of Drugs Used for the Treatment of Metabolic Disorders ...
599
Assessment of the Effects of Chemotherapeutic Agents ...
625
Assessment of Drugs Affecting the Inflammatory Process and Pain ...
655
Index
703
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About the author (2020)

John O'grady Medical Director May and Baker Pharmaceuticals Rhône-Poulenc Ltd Dagenham RMlO 7XS, UK and Visiting Professor of Clinical Pharmacology University of Vienna, Austria and Otto I. Linet Director of Clinical Development Unit 1 The Upjohn Company Kalamazoo, MI 49001, USA

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