Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

EMA versus US-FDA regulatory requirements regarding bioequivalence of orally administered generics ***

Katja Heiss (Abschlußjahr: 2014)

Summary
Language: English
This master thesis provides an introduction to the field of bioequivalence studies, focussing on generic oral immediate-release and modified-release formulations with one chemical drug substance. After a short overview of the scientific background of bioequivalence, it summarizes the relevant regulations and guidelines issued by the European Medicines Agency and the United States Food and Drug Administration, pointing out similarities and differences in the recommendations. Additional attention is given to recommendations regarding oral locally applied drugs acting locally in the gastrointestinal tract. An approach is made to evaluate in a general manner as well as for specific selected drug substances and formulations, if a common study design can be found that supports a generic application according to the Directive 2001/83/EC, Article 10.1 in the European Union as well as an Abbreviated New Drug Application according to the Code of Federal Regulations, Title 21, Section 314.94 in the United States of America. Furthermore, a short outlook is provided regarding currently ongoing scientific developments that might revolutionize the whole approach for establishing bioequivalence between two drug formulations.
Pages: 54, Annex: pages: 22