Regulatory agencies have long recognized, that for some drug products, in vivo BA/BE may be self-evident, and, as such, will waive the requirement for in vivo evidence in certain circumstances (grant a biowaiver). The use of biowaivers is in the spirit of avoiding unnecessary human testing whenever possible and facilitate access to drugs. This course will focus on the various biowaivers types, the possibilities opened, but also the limitations. It will highlight the data needed and the way to present them.
Locally applied locally acting biowaivers
IVIVC based biowaivers
Data to support biowaivers
What to include in the dossier
Benefits of attending
Recognize when to use a biowaiver approach?
Analyse the available data and the chance of success
Learn how to construct a biowaiver dossier
Understand the various data needed and the key issues for biowaivers
Evaluate & optimise the biowaiver strategy in connection with product development