Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

The AAPS Journal
Sam H HaidarLawrence X Yu

Abstract

Various approaches for evaluating the bioequivalence (BE) of highly variable drugs (CV > or = 30%) have been debated for many years. More recently, the FDA conducted research to evaluate one such approach: scaled average BE. A main objective of this study was to determine the impact of scaled average BE on study power, and compare it to the method commonly applied currently (average BE). Three-sequence, three period, two treatment partially replicated cross-over BE studies were simulated in S-Plus. Average BE criteria, using 80-125% limits on the 90% confidence intervals for C (max) and AUC geometric mean ratios, as well as scaled average BE were applied to the results. The percent of studies passing BE was determined under different conditions. Variables tested included within subject variability, point estimate constraint, and different values for sigma(w0), which is a constant set by the regulatory agency. The simulation results demonstrated higher study power with scaled average BE, compared to average BE, as within subject variability increased. At 60% CV, study power was more than 90% for scaled average BE, compared with about 22% for average BE. A sigma(w0) value of 0.25 appears to work best. The results of this research...Continue Reading

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Citations

Jun 15, 2011·Journal of Neurology·Eugen TrinkaMartin Graf
Apr 14, 2011·Pharmaceutical Research·Mei-Ling ChenLawrence X Yu
Jan 27, 2012·Pharmaceutical Research·Robert A LionbergerLawrence X Yu
Aug 29, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Vangelis KaralisPanos Macheras
Oct 13, 2009·Clinical Pharmacokinetics·Laszlo TothfalusiAlfredo Garcia Arieta
Jun 7, 2013·Therapeutic Delivery·Xinyuan ZhangLawrence X Yu
Jun 12, 2012·Expert Opinion on Drug Metabolism & Toxicology·Vangelis Karalis, Panos Macheras
Aug 21, 2012·Statistics in Medicine·Jason J Z Liao, Patrick F Darken
Apr 24, 2013·Pharmaceutical Development and Technology·Shriram M PathakV Venkateswarlu
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Sep 13, 2014·Wiley Interdisciplinary Reviews. Computational Statistics·Shein-Chung Chow
Aug 29, 2019·Journal of Biopharmaceutical Statistics·Jason J Z Liao, Yifang Li
Dec 14, 2011·Pharmaceutical Statistics·Scott D Patterson, Byron Jones
Nov 20, 2014·Pharmaceutical Statistics·Liping Du, Leena Choi
Mar 21, 2012·Journal of Clinical Pharmacy and Therapeutics·S Li
Aug 30, 2017·Statistics in Medicine·Laszlo Tothfalusi, Laszlo Endrenyi
Jun 14, 2019·Pharmaceutical Statistics·Jordi Ocaña, Joel Muñoz
Feb 25, 2019·Journal of Pharmacokinetics and Pharmacodynamics·Laszlo Endrenyi, Laszlo Tothfalusi
Jan 25, 2018·European Journal of Clinical Pharmacology·Sophie I E KnahlMeinhard Kieser
Aug 2, 2011·International Journal of Pharmaceutics·Wenlei JiangLawrence X Yu

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