Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans

Clinical Pharmacology and Therapeutics

Volumn 59, Issue 3, 1996, Pages 265-267

  Choudary, J ^a   Contrera, J F ^a   DeFelice, A ^a   DeGeorge, J J ^a   Farrelly, J G ^a   Fitzgerald, G ^a   Goheer, M A ^a   Jacobs, A ^a   Jordan, A ^a   Meyers, L ^a   Osterberg, R ^a   Resnick, C ^a   Sun, C J ^a   Temple, R J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ADVERSE DRUG REACTION; ANIMAL EXPERIMENT; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HISTOPATHOLOGY; HUMAN; INTOXICATION; NONHUMAN; NOTE; PHARMACODYNAMICS; PRIORITY JOURNAL;

ANIMALS; DRUG TOXICITY; HUMANS; MALE; PHARMACEUTICAL PREPARATIONS; PHARMACOLOGY; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0029929516     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0009-9236(96)80003-8     Document Type: Note

References (0)