United States Food and Drug Administration requirements for the approval of generic drug products

Journal of Clinical Psychiatry

Volumn 62, Issue SUPPL. 5, 2001, Pages 4-9

  Meyer, M C ^a  

^a UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLOZAPINE; GENERIC DRUG; NEUROLEPTIC AGENT;

BIOEQUIVALENCE; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MENTAL DISEASE; PRIORITY JOURNAL; REVIEW;

CLOZAPINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG APPROVAL; DRUGS, GENERIC; MENTAL DISORDERS; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035073507     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Subject-by-formulation interaction in bioequivalence: Conceptual and statistical issues
2. Normal volunteers should not be used for bioavailability or bioequivalence studies of clozapine