Exploration of the potential impact of batch-to-batch variability on the establishment of pharmacokinetic bioequivalence for inhalation powder drug products.

ABSTRACT: Batch-to-batch variability in inhalation powder has been identified as a potential challenge in the development of generic versions. This study explored the impact of batch-to-batch variability on the probability of establishing pharmacokinetic (PK) bioequivalence (BE) in a two-sequence, two-period (2 × 2) crossover study. A model-based parametric simulation approach was employed, incorporating batch-to-batch variability through the relative bioavailability (RBA) ratio. In the absence of batch variability, recruiting a total of 48 subjects in a 2 × 2 crossover study with the reference formulation resulted in a 95% probability of concluding BE. However, this probability decreased to 80% with a 5% batch difference in RBA and further declined to 30% with a 10% batch difference. With a 10% bat

SUBMITTER: Li S 

PROVIDER: S-EPMC11812940 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature