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International Journal of Clinical Pharmacology and Therapeutics

Volumn 39, Issue 8, 2001, Pages 350-355

Limits of 80% - 125% for AUC and 70% - 143% for Cmax. What is the impact on bioequivalence studies?

(5) Hauck, W W a Parekh, A a Lesko, L J a Chen, M L a Williams, R L a

a THOMAS JEFFERSON UNIVERSITY (United States)

Author keywords

Bioequivalence; Confidence intervals; Sample size

Indexed keywords

GENERIC DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DIET RESTRICTION; DIETARY INTAKE; FOOD AND DRUG ADMINISTRATION; MAXIMUM ALLOWABLE CONCENTRATION; PHARMACOKINETICS; UNITED STATES;

EID: 0034906872 PISSN: 09461965 EISSN: None Source Type: Journal
DOI: 10.5414/CPP39350 Document Type: Article

Times cited : (36)

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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.