An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence

Author:

Tothfalusi Laszlo,Endrenyi Laszlo

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference31 articles.

1. Haidar SH, Davit BM, Chen M-L, Conner D, Lee LM, Li QH, et al. Bioequivalence approaches for highly variable drugs and drug products. Pharm Res. 2008;25:237–41.

2. Hyslop T, Hsuan F, Holder DJ. A small sample confidence interval approach to assess individual bioequivalence. Stat Med. 2000;19(20):2885–97.

3. Tothfalusi L, Endrenyi L, Arieta AG. Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence. Clin Pharmacokinet. 2009;48:725–43.

4. FDA. Draft guidance for industry: statistical approaches to establishing bioequivalence. Rockville: Center for Drug Evaluation and Research (CDER); 2001.

5. FDA. Draft guidance for industry: bioequivalence recommendations for progesterone oral capsules. Silver Spring: Center for Drug Evaluation and Research (CDER); 2011.

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