Evaluation of the proposed FDA pilot dose-response methodology for topical corticosteroid bioequivalence testing

Pharmaceutical Research

Volumn 14, Issue 3, 1997, Pages 303-308

  Demana, Patrick H ^a   Smith, Eric W ^a   Walker, Roderick B ^a   Haigh, John M ^a   Kanfer, Isadore ^a  

^a RHODES UNIVERSITY   (South Africa)

Author keywords

Betamethasone 17 valerate cream; Chromameter; Human skin balancing assay; Pharmacodynamic modelling; Pilot dose response study

Indexed keywords

BETAMETHASONE VALERATE; LENOVATE; UNCLASSIFIED DRUG;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DOSE RESPONSE; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; INTERMETHOD COMPARISON; NORMAL HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; SKIN COLOR; TECHNIQUE; TOPICAL DRUG ADMINISTRATION; VASOCONSTRICTION;

ADMINISTRATION, TOPICAL; ANTI-INFLAMMATORY AGENTS; BETAMETHASONE 17-VALERATE; BIOLOGICAL AVAILABILITY; COLOR; DOSE-RESPONSE RELATIONSHIP, DRUG; EVALUATION STUDIES; FEMALE; GLUCOCORTICOIDS; HUMANS; MALE; MODELS, BIOLOGICAL; SKIN ABSORPTION; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030941982     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1012089803281     Document Type: Article

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