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- Title
Determination of Cohort Size for Studies of Bioequivalence Using Computer Modeling.
- Authors
Arnautov, V.; Reikhart, D.; Borisov, A.
- Abstract
The randomized crossover (2 × 2) protocol is a standard design for studies of bioequivalence, reducing intraindividual variability. Determination of cohort size for studies of bioequivalence is an important element in planning studies and must be evidence-based. The aim of the present work was to produce and validate an algorithm for determining the required cohort size for studies of bioequivalence using computer simulation. The proposed algorithm is based on a procedure for assessing the power of the statistical test for known numbers of observations, variance, and preset values of acceptable first-order error levels.
- Subjects
THERAPEUTIC equivalency in drugs; COMPUTER simulation; PHARMACOKINETICS; ALGORITHMS; STATISTICAL reliability
- Publication
Pharmaceutical Chemistry Journal, 2017, Vol 51, Issue 7, p528
- ISSN
0091-150X
- Publication type
Article
- DOI
10.1007/s11094-017-1648-6