Early Phase Drug Evaluation in Man

Front Cover
CRC Press, 1990 M09 5 - 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

The Pharmacological Background
14
The Metabolic Background
25
The Toxicological Background
39
Animal Tests as Predictors of Human Response
63
International Regulatory Requirements
83
Regulatory Requirements in Japan
89
Industry
99
Decision Points in Human Drug Development
121
Measurement of CNS Effects
379
Drugs in Epilepsy
395
Hypnotics
421
Antipsychotic Agents
443
Measurement of Gastrointestinal Effects
457
Antiulcer Drugs
481
Diuretics 495 38 Diuretics
495
Measurement of Renal Sideeffects
508

Good Clinical Research Practice and Quality Assurance
127
Ethical Aspects of Research in Healthy Volunteers
139
Ethical Aspects of Research in Patients
150
Volunteers
195
Phase Patient Trials
214
The Assessment of Pharmacokinetics
229
Radiolabelled Metabolism Studies in Man
243
Antianginal Drugs
265
Antiarrhythmic Agents
288
Drugs for Heart Failure
313
Antithrombotic and Thrombolytic Drugs
326
Assessment of Respiratory Responses
351
Abortifacient Drugs 521 40 Abortifacient Drugs
521
Measurement of Skin Response to Drugs 553 42 Measurement of Skin Response to Drugs
566
Drugs Affecting Hair Growth
586
Assessment of Drugs Used for the Treatment of Metabolic
599
Antidiabetic Drugs
613
Antibacterial Drugs
627
Anticancer Drugs
644
Assessment of Drugs Affecting the Inflammatory Process and Pain
655
Antiinflammatory Drugs
674
Analgesics
689
Index
703
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