New Model–Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling-Reference-Cited by-同舟云学术

New Model–Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling

Published:2020-10-30 Issue:6 Volume:22 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Loingeville Florence^ORCID,Bertrand Julie,Nguyen Thu Thuy,Sharan Satish,Feng Kairui,Sun Wanjie,Han Jing,Grosser Stella,Zhao Liang,Fang Lanyan,Möllenhoff Kathrin,Dette Holger,Mentré France

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-020-00507-3.pdf

Reference24 articles.

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2. EMEA C. Note for guidance on the investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98, London; 2001.

3. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15(6):657–80.

4. Shen M, Machado SG. Bioequivalence evaluation of sparse sampling pharmacokinetics data using bootstrap resampling method. J Biopharm Stat. 2017;27(2):257–64.

5. Dubois A, Gsteiger S, Pigeolet E, Mentre F. 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. Pharm Res. 2010;27(1):92–104.

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