Literature DB >> 1526691

Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.

E Diletti1, D Hauschke, V W Steinijans.   

Abstract

For the two-period crossover design and a multiplicative model (logarithmic normal distribution) the decision procedure of choice is based on the inclusion of the shortest 90%-confidence interval for the ratio of expected medians for test and reference in the equivalence range. This inclusion rule is equivalent to the two one-sided tests procedure. Sample sizes based on the power of the latter have been given by Diletti et al. [1991] for an equivalence range of 0.8 to 1.25. Corresponding tables for the tighter equivalence range of 0.9 to 1.11 as well as for the wider range of 0.7 to 1.43 are given in this amendment.

Mesh:

Year:  1992        PMID: 1526691

Source DB:  PubMed          Journal:  Int J Clin Pharmacol Ther Toxicol        ISSN: 0174-4879


  2 in total

1.  A note on sample size determination for bioequivalence studies with high-order crossover designs.

Authors:  K W Chen; S C Chow; G Li
Journal:  J Pharmacokinet Biopharm       Date:  1997-12

2.  Generic products of antiepileptic drugs: a perspective on bioequivalence, bioavailability, and formulation switches using Monte Carlo simulations.

Authors:  Vangelis Karalis; Panos Macheras; Meir Bialer
Journal:  CNS Drugs       Date:  2014-01       Impact factor: 5.749

  2 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.