Modified technique used in human bioassay of four butyrophenone derivatives in psychoneurotic patients

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Abstract
Too often, following animal and acute human pharmacologic studies, insufficient information is available for the efficient and safe design of an adequately controlled double blind study in man. The single blind human bioassay of psychopharmacologic drugs, utilizing a spectrum of clinical conditions, may provide a rough estimate of the dose‐response relationship for clinical improvement, the dose‐response relationship for toxic effects, and an estimate of diagnostic categories in which potential usefulness may be established by double blind evaluation. This procedure avoids the expense of large numbers of toxicologic studies and provides the first screening for actual rejection of a drug from more complex and expensive thorough clinical investigation. The use of the modified technique is illustrated by studies with four butyrophenone derivatives (R‐1625, R‐1647, R‐1892, and R‐2167) in 151 patients. The dose‐response curves for these drugs, including the ED50 and the TD50 of each, were obtained in psychoneurotic outpatients and were found to correlate well with the ED50 for animal conditioned avoidance behavior block and with the LD50 in mice.

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