Bioequivalence Tests Based on Individual Estimates Using Non-compartmental or Model-Based Analyses: Evaluation of Estimates of Sample Means and Type I Error for Different Designs

Author:

Dubois Anne,Gsteiger Sandro,Pigeolet Etienne,Mentré France

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference40 articles.

1. FDA. Guidance for industry-statistical approaches to establishing bioequivalence. Technical report, FDA; 2001.

2. EMEA. Note for guidance on the investigation of bioavailability and bioequivalence. Technical report, EMEA; 2001.

3. Gabrielson J, Weiner D. Pharmacokinetic and pharmacodynamic data analysis: concepts and applications. Stockholm: Apotekarsocieteten; 2006.

4. Jusko WJ, Koup JR, Alván G. Nonlinear assessment of phenytoin bioavailability. J Pharmacokinet Biopharm. 1976;4:327–36.

5. Hayashi N, Aso H, Higashida M, Kinoshita H, Ohdo S, Yukawa E, et al. Estimation of rhG-CSF absorption kinetics after subcutaneous administration using a modified Wagner-Nelson method with a nonlinear elimination model. Eur J Pharm Sci. 2001;13:151–8.

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