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Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability

Burmeister Getz Elise,Carroll Kevin J.,Christopher J. David,Morgan Beth,Haughie Scott,Cavecchi Alessandro,Wiggenhorn Christopher,Beresford Hayden,Strickland Helen,Lyapustina Svetlana

AAPS PharmSciTech（2021）

Cited 4|Views14
Key words
bioequivalence,pharmacokinetic,batch-to-batch variability,multiple-batch,type I error
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