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A scientific rationale for choosing patients rather than normal subiects for Phase I studies
Author(s) -
Oates John A.
Publication year - 1972
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1972135part2809
Subject(s) - disposition , bioavailability , disease , intensive care medicine , medicine , adverse effect , drug , phase (matter) , pharmacology , risk analysis (engineering) , psychology , chemistry , social psychology , organic chemistry
The determination of safety and adverse effects in Phase I together with investigations on the disposition and bioavailability of the drug often provide a better scientific and ethical basis if conducted with knowledge of the dose required to produce the desired pharmacologic effect. Because certain pharmacologic effects are specific for the disease state, Phase I studies on stich drugs should be conducted only in carefully selected patients with the appropriate disease.