Early Phase Drug Evaluation in ManCRC 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 |
The Organisation of New Drug Evaluation in the Pharmaceutical | 99 |
The Role of Contract Research Units | 110 |
Drugs in Epilepsy | 395 |
Hypnotics | 421 |
Antipsychotic Agents | 443 |
Measurement of Gastrointestinal Effects | 457 |
Antiulcer Drugs | 481 |
Diuretics | 495 |
Measurement of Renal Sideeffects | 508 |
Abortifacient Drugs | 521 |
Good Clinical Research Practice and Quality Assurance | 127 |
Ethical Aspects of Research in Healthy Volunteers | 139 |
Ethical Aspects of Research in Patients | 150 |
The Assessment of Tolerance and Sideeffects in Nonpatient | 195 |
The Detection and Assessment of Adverse Reactions in Early | 214 |
The Assessment of Pharmacokinetics | 229 |
Radiolabelled Metabolism Studies in Man | 243 |
Antianginal Drugs | 265 |
Antiarrhythmic Agents | 288 |
Phase I Trials on Antihypertensive Drugs | 302 |
Antithrombotic and Thrombolytic Drugs | 326 |
Assessment of Respiratory Responses | 351 |
Measurement of CNS Effects | 379 |
Measurement of Skin Response to Drugs | 553 |
Drugs for Eczema | 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 |
703 | |
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Common terms and phrases
absorption acid action activity acute administration adverse agents animal antidepressant anxiety anxiolytic assay assessment asthma benzodiazepines bioavailability biological blood pressure cardiac output cells changes chronic Clin clinical research clinical trials compound concentration conducted consent coronary corticosteroids determine disease diuretics dosage dose drug development duration eczema effects of drugs efficacy enantiomers enzyme ethics committee evaluation excretion exercise factors function gastric gastrointestinal gastrointestinal tract glucose guidelines haemodynamic healthy volunteers human important increase induced inotropic intravenous investigator laboratory lesions levels measured metabolism metabolites method minoxidil monitoring myocardial normal NSAIDs oral pain parameters patients performed Pharm pharmaceutical pharmacodynamic pharmacokinetic pharmacological Phase I studies placebo plasma platelet potential preclinical predictive produce prostaglandin protocol receptor regulatory renal response risk safety scales Shuster side-effects skin specific subjects symptoms techniques therapeutic therapy tion tolerance toxicology treatment urine uterine viral visual analogue scales vivo