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

Hauck, W W; Parekh, A; Lesko, L J; Chen, M L; Williams, R L

Hauck, W W; Parekh, A; Lesko, L J; Chen, M L; Williams, R L.

Affiliation

Hauck WW; Biostatistics Section, Division of Clinical Pharmacology, Thomas Jefferson University, Philadelphia, PA 19107, USA. whauck@lac.jci.tju.edu

Int J Clin Pharmacol Ther ; 39(8): 350-5, 2001 Aug.

Article in En | MEDLINE | ID: mdl-11515710

Subject(s)

Pharmacokinetics; United States Food and Drug Administration; Area Under Curve; Fasting; Humans; Reference Values; Research Design; Sample Size; Therapeutic Equivalency; United States

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Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Pharmacokinetics Type of study: Prognostic_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Int J Clin Pharmacol Ther Year: 2001 Document type: Article

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