1. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification;Cder,2015
2. Dissolution testing of immediate release solid oral dosage forms;Cder,1997
3. Extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations;Cder,1997
4. SUPAC-IR: immediate-release solid oral dosage forms: scale-up and post-approval changes: chemistry, manufacturing and controls;Cder,1995
5. CDER patient-focused drug development;Cder,2019