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. |
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Page 20
... reported in the submission . Gastrointestinal System The effects of new compounds on gastric acid secretion in anaesthetised rats or specific measurements of gastrointestinal motility in rats or rabbits are usually only reported if the ...
... reported in the submission . Gastrointestinal System The effects of new compounds on gastric acid secretion in anaesthetised rats or specific measurements of gastrointestinal motility in rats or rabbits are usually only reported if the ...
Page 21
... reported . If the compound exhibits proinflammatory reactions , clearly this property should be reported and , if possible , examined in more detail , as an indication of a potential side - effect of the NCE . Platelet Function If ...
... reported . If the compound exhibits proinflammatory reactions , clearly this property should be reported and , if possible , examined in more detail , as an indication of a potential side - effect of the NCE . Platelet Function If ...
Page 545
... reported a subjective increase in bleeding associated with a fall in haemoglobin concentration ( Couzinet et al . , 1986 ) , and acute haemorrhage necessitating emergency curettage has also been reported ( Kovacs et al . , 1984 ...
... reported a subjective increase in bleeding associated with a fall in haemoglobin concentration ( Couzinet et al . , 1986 ) , and acute haemorrhage necessitating emergency curettage has also been reported ( Kovacs et al . , 1984 ...
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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