Biowaiver for generic products
- At: 2014 FIP Congress in Bangkok (Thailand)
- Type: Presentation
- By: CRISTOFOLETTI, Rodrigo (Brazilian Health Surveillance Agency (ANVISA), Bioequivalence Department, Brasilia, Brazil)
Background: New drugs have to be approved on the basis of safety and efficacy trials. For generic versions, these studies do not have to be repeated as long as the generic version has a similar pharmacokinetic profile to the innovator. In recent years it has also become possible under some circumstances to replace the pharmacokinetic study with a.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.