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 386
... activities and a decrease in alpha activity ; the second , by an increase in alpha activity and an increase in slow and fast activities . The former profile is indicative of sedative properties ; the latter , of activating properties ...
... activities and a decrease in alpha activity ; the second , by an increase in alpha activity and an increase in slow and fast activities . The former profile is indicative of sedative properties ; the latter , of activating properties ...
Page 460
... activity , Phase II by a period of irregular contractile activity followed by a characteristic propagated burst of contractions ( Phase III ) . To ensure registration of an adequate number of migrating motor com- plexes , as well as ...
... activity , Phase II by a period of irregular contractile activity followed by a characteristic propagated burst of contractions ( Phase III ) . To ensure registration of an adequate number of migrating motor com- plexes , as well as ...
Page 537
... activity ' and was expressed in Montevideo Units ( MU ) . Thus , MUS can be derived by summing all the individual active pressures in a given 10 min period or by multiplying mean active pressure by the mean frequency per 10 min over the ...
... activity ' and was expressed in Montevideo Units ( MU ) . Thus , MUS can be derived by summing all the individual active pressures in a given 10 min period or by multiplying mean active pressure by the mean frequency per 10 min over the ...
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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