Affiliation: | 1. Baxalta Innovations GmbH, a Takeda company, Vienna, Austria;2. Consultant, Berlin, Germany;3. BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Vienna, Austria;4. Bayer AG, Berlin, Germany;5. Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany;6. Austrian Medicines and Medical Devices Agency, Wien, Austria;7. Department of Mathematics and Statistics, Lancaster University, Lancaster, UK;8. Shire, a Takeda company, Lexington, Massachusetts, USA |