In which cases can human studies be waived: The ground rules
- At: 2010 FIP Congress in Lisbon (Portugal)
- Type: Presentation
- By: DRESSMAN, Jennifer (Goethe University, Frankfurt am Main, Germany)
Although pharmacokinetic studies in humans represent the "gold standard" for establishing bioequivalence of drug products, several regulatory authorities (e.g. WHO, FDA, EMEA) have opened the way to alternative approaches. The methods are based on dissolution testing and thus represent savings in terms of both costs and unnecessary exposure of.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.