A Simple Three-Step Procedure for Parametric and Nonparametric Assessment of Bioequivalence

Author:

Vuorinen Jouni,Turunen Jari

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Reference29 articles.

1. FDA. Guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design. Informal communication by the Division of Bioequivalence, Office of Generic Drugs, Rockville, MD; 1992.

2. Commission of the European Communities. CPMP Working Party on Efficacy of Medicinal Products. Note for guidance: Investigation of bioavailability and bioequivalence; 1991.

3. Anderson S, Hauck WW. Considerations of individual bioequivalence. J Pharmacokin Biopharm. 1990; 18(3): 259–273.

4. Hauck WW, Anderson S. Individual vs. average bioequivalence: when is average not sufficient. Proceedings of Bio-International ’94. Munich; 1994.

5. Schall R. A unified view of individual, population and average bioequivalence. Proceedings of Bio-International ’94. Munich; 1994.

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4. Some Conceptual Issues in the Evaluation of Average, Population, and Individual Bioequivalence;Drug Information Journal;2001-07

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