Novel low-cost approach for in-vitro determination of bioavailability for immediate release solid oral dosage forms
- At: 2014 FIP Congress in PSWC, Melbourne (Australia)
- Type: Presentation
- By: CECIL, Todd (USP, Chemical Medicines, Rockville, United States of America)
In-vitro dissolution testing provides the basis for a variety of approaches to limit the amount of clinical trials necessary to determine the acceptability of generic products. One of the most successful was the Biopharmaceutical Classificiation System (BCS) Biowaiver. Extensions of the principals of BCS have been proposed but all have met with.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.