Early Phase Drug Evaluation in ManO'grady, Otto I. Linet 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. |
From inside the book
Results 1-3 of 73
Page 215
... adverse reactions causing termination , or pharmacological unwanted effects such as , for example , an extreme slowing of the AV - conduction time . However , it is possible that in some Phase I studies adverse reactions will occur that ...
... adverse reactions causing termination , or pharmacological unwanted effects such as , for example , an extreme slowing of the AV - conduction time . However , it is possible that in some Phase I studies adverse reactions will occur that ...
Page 217
... adverse event , several methods have been developed . The most reliable is the rechallenge , as described by Karch and Lasagna ( 1975 ) . By definition , a specific adverse event is described as drug - related if it disappears on ...
... adverse event , several methods have been developed . The most reliable is the rechallenge , as described by Karch and Lasagna ( 1975 ) . By definition , a specific adverse event is described as drug - related if it disappears on ...
Page 219
... adverse reactions , as single events , to events recorded in hospital records and in clinical follow - up of the patient's condition . An example of where record linkage may be useful is neutropenia or agranulocytosis . Hospital charts ...
... adverse reactions , as single events , to events recorded in hospital records and in clinical follow - up of the patient's condition . An example of where record linkage may be useful is neutropenia or agranulocytosis . Hospital charts ...
Other editions - View all
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 heart human important increase induced insulin intravenous investigator laboratory 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