Model-Based Approach for Designing an Efficient Bioequivalence Study for Highly Variable Drugs.

ABSTRACT: The statistical procedures as outlined by the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) guidelines for bioequivalence testing of highly variable drugs (HVDs) are complex. Additionally, the sample size is affected by clinical study designs or practical real-world problems, such as dropout rate or study budget. To overcome these difficulties, we propose a model-based approach for the selection of a study design with a sample size that satisfies the bioequivalence criteria using simulation studies based on a pharmacokinetic (PK) model. The designed approach was implemented using a simulation procedure considering some conventionally measured factors, such as geometric mean ratio and within-subject coefficient of variation, with various PK information

SUBMITTER: Song E 

PROVIDER: S-EPMC8624447 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature