Oral Biopharmaceutics Risk Assessment Framework (HP-00118034)
The University of Maryland Baltimore aims to conduct pharmaceutical research on drug product quality, specifically public standards for oral solid dosage forms (e.g. tablets and capsules) via in vitro dissolution testing. This survey study involves research. Your input will aid us to identify situations when it may be appropriate or not appropriate to require in vitro dissolution testing for a new batch of manufactured oral solid dosage forms (e.g. tablets and capsules), and how to justify the suitability of the in vitro dissolution testing method in terms of in vivo product performance.
Basic eligibility criteria: Adults with an interest in promoting public standards for oral solid dosage forms (e.g. tablets and capsules) via in vitro dissolution testing.
Survey Details
Take the online survey. The survey will take approximately 25 minutes to complete.
The deadline for taking the survey is Monday, March 16 2026 at 5 p.m. ET. Summary results will be shared with FDA and the public. No individual survey results will be shared with the FDA or the public.
View a PDF version of the Biopharmaceutics Risk Assessment Framework Survey.
View a PDF of Lawrence Yu’s recent presentation Perspectives on the Future State of Dissolution Testing.
Contact James Polli (Principal Investigator), jpolli@rx.umaryland.edu for more information, questions, or enrollment.