Comparative evaluation of US food and drug administration and pharmacologically guided approaches to determine the maximum recommended starting dose for first-in-human clinical trials in adult healthy men

Journal of Clinical Pharmacology

Volumn 51, Issue 12, 2011, Pages 1655-1664

  Imam, Md Tarique ^a   Venkateshan, S P ^b   Tandon, Monika ^b   Saha, Nilanjan ^b   Pillai, K K ^a  

^a HAMDARD UNIVERSITY   (India)

^b RANBAXY LABORATORIES LTD   (India)

Author keywords

clinical pharmacology; clinical research; clinical trials; pharmacokinetics drug metabolism; pharmacology

Indexed keywords

ARIPIPRAZOLE; CELECOXIB; DESVENLAFAXINE; ENTECAVIR; FOSAMPRENAVIR; MOXIFLOXACIN; PARICALCITOL; RABEPRAZOLE; ROSUVASTATIN; THALIDOMIDE;

ACCURACY; ALLOMETRY; ANIMAL EXPERIMENT; ARTICLE; BRAIN WEIGHT; CLINICAL STUDY; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED STUDY; DOG; DRUG CLEARANCE; DRUG DISTRIBUTION; FOOD AND DRUG ADMINISTRATION; HAPLORHINI; INFORMATION RETRIEVAL; MAXIMUM LIFE SPAN POTENTIAL; MAXIMUM RECOMMENDED STARTING DOSE; NONHUMAN; PARAMETER; PHARMACODYNAMICS; PHARMACOLOGICALLY GUIDED APPROACH; PREDICTIVE VALUE; RAT; RECOMMENDED DRUG DOSE; RULE OF EXPONENT;

ADULT; ANIMALS; DOGS; DRUG EVALUATION, PRECLINICAL; HAPLORHINI; HUMANS; MALE; METABOLIC CLEARANCE RATE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RATS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 82955187888     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010387429     Document Type: Article

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