Bioequivalence studies: biometrical concepts of alternative designs and pooled analysis

Author:

Zintzaras E.,Bouka P.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference9 articles.

1. Chow S.C., Liu J.P. (1992): Design and analysis of bioavailability and bioequivalence studies.

2. Schuirmann D.J. (1990): Statistical evaluation of bioequivalence studies. In: Sharma K.N., Sharma K.K., Sen P. Eds. Generic Drugs, Bioequivalence and Pharmacokinetics, UCMS, Delhi, pp 119–125.

3. CPMP: Note for guidance on the investigation of bioavailability and bioequivalence. In: The Rules Governing Medicinal Products for Human Use in the Member States of the European Community, Volume III, Addendum No 2, Guidelines on the Quality, Safety & Efficacy of Medicinal Products for Human Use pp 149–168.

4. Metzler C.M. (1974): Bioavailability — a problem in equivalence. Biometrics, 30, 309–317.

5. Jones B., Kenward M.G. (1995): Design and Analysis of Crossover Trials. London: Chapman and Hall.

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