Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons

Author:

Gwaza Luther,Gordon John,Potthast Henrike,Welink Jan,Leufkens Hubert,Stahl Matthias,García-Arieta Alfredo

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference16 articles.

1. World Health Organization (2006) Annex 7: multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO technical report series 937: WHO expert committee on specifications for pharmaceutical preparations. WHO Press, Geneva, pp. 347–390

2. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) (2003) Bioavailability and bioequivalence. Studies for orally administered drug products-general considerations. CDER, Washington D.C.

3. Committee for Medicinal Products for Human Use (CHMP) (2010) Guideline on the investigation of bioequivalence. European Medicines Agency (EMA), London

4. Chow, S.C., Liu, J.P., (2000) Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York: Marcel Dekker.

5. Gwaza L, Gordon J, Welink J, Potthast H, Hansson H, Stahl M, et al (2012) (2012) Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO. Eur J Clin Pharmacol 68:1611–1618

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