- On November 2-3, 2017, PQRI and USP will hold the 3rd PQRI/USP Workshop on Implementation Status of ICH Q3D Elemental Impurities Requirements – Analytical and Risk Assessment Challenges. Registration will open soon.
- On March 22-24, 2017, FDA and PQRI held the 3nd FDA/PQRI Conference on Advancing Product Quality at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center in Rockville, MD USA. The 3rd FDA/PQRI Quality Conference brought together leaders from FDA, industry and academia to discuss key, critical topics in drug product quality. Presentations from the Conference are available. Click here for presentations.
- The PQRI Stability Shelf Life Working Group Paper Evaluating Current Practices in Shelf Life Estimation has been published in AAPS PharmSciTech and is available at this link.
- The PQRI Solubility, Permeability Review Paper – Evolution of Choice of Solubility and Dissolution Media after Two Decades of Biopharmaceutical Classification System has been published in the AAPS Journal and is available at this link.
- PQRI’s PODP Working Group’s paper Simulated Leaching (Migration) Study for a Model Container Closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs) has been published in the PDA Journal of Pharmaceutical Science and Technology. This publication is in support of the PODP WG’s forthcoming recommendations.
- On November 9-10, 2016, PQRI hosted a public Workshop: PQRI/USP Workshop on Implementation Status of ICH Q3D Elemental Impurities Requirements – Analytical and Risk Assessment Challenges. Click here to access presentations.
- On October 5 – 7, 2015, FDA and PQRI hosted a public conference “2nd FDA/PQRI Conference on Advancing Product Quality.” This Conference brought together regulatory, academic, and industry experts. Inputs from attendees will aid in future FDA guidance development. Click here to access the presentations. The report from the 2nd FDA/PQRI Conference has been published in The AAPS Journal, DOI 10.1208/s12248-016-9874-5.
- The PQRI BCS Class III Biowaiver Working Group recently published an article in Pharmaceutical Research.
- The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers. Parr, Alan; Hidalgo, Ismael J.; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario A.; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika S., August 2015, Pharmaceutical Research.
PQRI in the news:
- Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose
Apr 17, 2017
International Pharmaceutical Quality (IPQ)
- Building Consensus for E&L Testing Standards
Mar 02, 2016
By Rita C. Peters
Volume 40, Issue 3, pg 46–48