Controlling type 1 error rate for sequential, bioequivalence studies with crossover designs
Author:
Affiliation:
1. Amgen; Thousand Oaks California
2. University of North Carolina; Chapel Hill North Carolina
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/pst.1911/fullpdf
Reference19 articles.
1. FDA Guidance 2000b BA and BE studies for orally administered drug products: general considerations
2. FDA Guidance 2001 Statistical approaches to establishing bioequivalence
3. Sequential design approaches for bioequivalence studies with crossover designs;Potvin;Pharm Stat,2008
4. Additional results for sequential design approaches for bioequivalence studies with crossover designs;Montague;Pharm Stat,2012
5. Optimal adaptive sequential designs for crossover bioequivalence studies;Xu;Pharm Stat,2016
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2. Simple and high sample throughput LC/ESI-MS/MS method for bioequivalence study of prazosin, a drug with risk of orthostatic hypotension;Drug Development and Industrial Pharmacy;2022-09-02
3. 10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?;Pharmaceutical Research;2020-07
4. Two-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies;Statistics in Biopharmaceutical Research;2019-09-06
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