Challenges and Changes in Bioequivalence Studies

Helmut Schutz, CEO of BEBAC, joins 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. He 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 regulatory compliance. Helmut Schutz will be speaking at the upcoming Bioequivalence and Bioavailability Studies conference in Munich from 25th-27th October. For more information on this event and booking enquiries please visit the website: www.bioequivalenceevent.com, call freephone 0800 652 2363 or email enquire@iqpc.co.uk.