Challenges and Changes in Bioequivalence Studies
Helmut Schutz, CEO of BEBAC, joins Helen Winsor from Pharma IQ, to talk about the challenge of sample sizes in bioequivalence studies. The interview explores the idea of literature data versus pilot studies, the key issue of optimum sample size estimation, and the viability of cost-cutting. Schutz also tackles the subject from a regulatory perspective - looking at the main challenges in gaining regulatory approval for biosimilars and the different approaches used in the past to ensure regul...
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