Biowaiver for generic products

• In: A7 - Regulatory facilitation of access to medicines on Wednesday, 3 September 2014, 12:15-13:45
• At: Bangkok (Thailand) (2014)
• Type: Presentation
• By: CRISTOFOLETTI, Rodrigo (Brazilian Health Surveillance Agency (ANVISA), Bioequivalence Department, Brasilia, Brazil)
• Abstract:

  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

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