Early Phase Drug Evaluation in ManJohn 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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Results 1-5 of 88
Page v
... Decision Making 8. The Organisation of New Drug Evaluation in the Pharmaceutical 97 Industry Y. Champey 99 9. The Role of Contract Research Units 110 A. P. Fletcher 10 . Decision Points in Human Drug Development 121 R. D. Mamelok and ...
... Decision Making 8. The Organisation of New Drug Evaluation in the Pharmaceutical 97 Industry Y. Champey 99 9. The Role of Contract Research Units 110 A. P. Fletcher 10 . Decision Points in Human Drug Development 121 R. D. Mamelok and ...
Page ix
... decision making in drug development . This is indeed an area where months , if not years , could be saved by more imaginative management . It is pleasing to see the comprehensive approach that John O'Grady and Otto Linet have adopted ...
... decision making in drug development . This is indeed an area where months , if not years , could be saved by more imaginative management . It is pleasing to see the comprehensive approach that John O'Grady and Otto Linet have adopted ...
Page x
... decision to be made to progress to the later , comprehensive , stages of drug development . Increasingly there is concern about the time delays in developing modern drugs and debate about ethical aspects of clinical trials . Both topics ...
... decision to be made to progress to the later , comprehensive , stages of drug development . Increasingly there is concern about the time delays in developing modern drugs and debate about ethical aspects of clinical trials . Both topics ...
Page 3
... or cell culture , isolation and purification steps . A decision to develop new drugs often depends on the results of ' screening ' , which involve testing of new drugs using whole animals or 3 1: The Pharmaceutical Background.
... or cell culture , isolation and purification steps . A decision to develop new drugs often depends on the results of ' screening ' , which involve testing of new drugs using whole animals or 3 1: The Pharmaceutical Background.
Page 4
... decision is made to develop a compound , usually the first step is to prepare a reasonable quantity of drug substance so that multidisciplinary approach to early investigation and development can begin . In order for a new drug to be ...
... decision is made to develop a compound , usually the first step is to prepare a reasonable quantity of drug substance so that multidisciplinary approach to early investigation and development can begin . In order for a new drug to be ...
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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absorption acid action activity acute administration adverse agents analgesic animal antidepressant anxiety anxiolytic assay assessment asthma benzodiazepines bioavailability biological blood pressure cardiac output cells changes chronic Clin clinical research clinical trials compound concentration consent coronary corticosteroids determine disease diuretics dosage dose drug development duration eczema effects of drugs efficacy enantiomers enzyme ethics committee evaluation excretion exercise experimental factors function gastric gastrointestinal gastrointestinal tract glucose guidelines healthy volunteers heart human important increase induced inhibition insulin intravenous investigator laboratory levels measurement metabolism metabolites method minoxidil monitoring myocardial normal NSAIDs oral pain parameters patients performed Pharm pharmaceutical pharmacodynamic pharmacokinetic pharmacological placebo plasma platelet potential preclinical predictive produce prostaglandin protocol receptor regulatory renal response rheumatoid arthritis risk safety scales Shuster side-effects skin specific studies subjects symptoms techniques therapeutic therapy tion tolerance toxicology treatment urine uterine visual analogue scales vitro vivo