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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Page 18
... evaluation . This latter study can also provide a valuable early indication of the effect of the NCE on liver metabolism , since liver enzyme induction or inhibition may be indicated by a decrease or increase in sleeping time ...
... evaluation . This latter study can also provide a valuable early indication of the effect of the NCE on liver metabolism , since liver enzyme induction or inhibition may be indicated by a decrease or increase in sleeping time ...
Page 19
... evaluation , although it is a general experience that the regulatory authorities are satisfied if such behavioural studies on the NCE are only conducted in rodents . Other secondary tests that are conducted under rare circumstances ...
... evaluation , although it is a general experience that the regulatory authorities are satisfied if such behavioural studies on the NCE are only conducted in rodents . Other secondary tests that are conducted under rare circumstances ...
Page 20
... evaluation in conscious dogs or rats . A more detailed evaluation of the effects of the NCE on renal function — for example , in conscious dogs - should be conducted if indicated in these preliminary tests . Inflammation The general ...
... evaluation in conscious dogs or rats . A more detailed evaluation of the effects of the NCE on renal function — for example , in conscious dogs - should be conducted if indicated in these preliminary tests . Inflammation The general ...
Page 21
... evaluation may provide useful preclinical information . Studies on platelet function ex vivo following administration of the NCE can also be determined ( Allan et al . , 1985 ) . The effects on other haematological parameters are ...
... evaluation may provide useful preclinical information . Studies on platelet function ex vivo following administration of the NCE can also be determined ( Allan et al . , 1985 ) . The effects on other haematological parameters are ...
Page 23
... evaluating both non - narcotic and narcotic analgesics . Proc . Soc . Exp . Biol . Med . , 95 , 729–31 Vernier , V. G. , Hanson , H. M. and Stone , C. A. ( 1962 ) . The pharmacodynamics of amitriptyline . In Nadine , J. H. and Moyer ...
... evaluating both non - narcotic and narcotic analgesics . Proc . Soc . Exp . Biol . Med . , 95 , 729–31 Vernier , V. G. , Hanson , H. M. and Stone , C. A. ( 1962 ) . The pharmacodynamics of amitriptyline . In Nadine , J. H. and Moyer ...
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