The mission of the Biopharmaceutics Technical Committee is to identify, disseminate, and facilitate scientific and technical projects to address gaps in biopharmaceutical aspects of drug development and global regulatory guidance. The BTC will translate current and emerging ideas in the pharmaceutical field into proposals for implementing unbiased research projects and delivering results that impact regulatory policies. For more information about the BTC, see the attached flyer.
Copies of BTC Minutes are available upon request. Please contact the PQRI Secretariat for copies of minutes.
Reports and White Papers are available at Publications.
- Current Working Groups
- Working Group on Multiple level C IVIVC, level A IVIVC, and BE in defining clinically relevant specifications for IR and MR products
- Topical Drug Classification System (with PQRI MTC)
- Development of a Biopharmaceutics Classification System (BCS) for Pulmonary Drugs
- BTC Webinar Series, click here to view information and recordings from past webinars.
- Emerging Projects
- QbD Working Group: White paper on “Challenges to and Opportunities in Comprehensive QbD Implementation”
- BTC Benchmarking Survey
- Past Projects
- BCS Review Paper – Two Decades of the Biopharmaceutics Drug Classification System: An Update on Solubility and Dissolution (published July 2017)
- BCS Class III Biowaivers – Evaluation of commonly used excipients in IR solid dosage forms on the intestinal permeability of several BCS III drugs provides a basis to extend BCS biowavers to Class III drugs and supports a revision of the FDA guidance.
- The Sequential Design WG – Scientific and regulatory research in bioavailability and bioequivalence study designs provided support for FDA policies and guidances for in vitro and in vivo methodologies.