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Part XI. Exploratory trials of new drugs in man
Author(s) -
Pfeiffer Carl C.
Publication year - 1962
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/cpt196233397
Subject(s) - clinical trial , meprobamate , medicine , pharmacology , toxicity , clinical pharmacology , pharmacodynamics , exploratory research , exploratory analysis , pharmacokinetics , computer science , data science , sociology , anthropology
A necessary function of many laboratories in clinical pharmacology is the exploratory trial of chemicals in man. Studies can be initiated in man after minimal toxicity studies have been performed in animals, such as the LD50 in one or two species, subacute toxicity, autopsies on growing rats after 4 week trials, and pharmacodynamic trials in dogs. Adequate exploratory trials in man avoid double blind tests of drugs at ineffective dose levels such as occurred in a test of driver impairment with meprobamate and whisky in normal volunteers. The published answer of this study was "no impairment of driving skill," whereas the data obviously desired were to determine the mean oral dose level of either or both that will impair driving skill! It is not my purpose to discuss quantitative or statistically reliable pharmacologic experiments in man but rather to elaborate on our experiences with exploratory studies in normal subjects and patients.