New USP Dissolution Performance Verification Standard: What, Where, and When

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Description

Recently the USP has released a series of Notices of Intent to Revise for Chapter <711>Dissolution. The major change in this revision is the replacement of the current PVT Prednisone RS, used to perform the USP required dissolution equipment Performance Verification Test (PVT), with a brand-new standard called the Dissolution Performance Verification Standard – Prednisone. The current USP FAQ page for this Notice of Intent to Revise lists the expected date for the revision to take effect as 01-May-2023, at which point the old Prednisone Reference material stops being valid for performing PVT testing, and the use of the DPVS becomes mandatory.

In view of the short timeframe and absolute nature of the change, the dissolution community has had a series of pressing questions regarding the implementation of this new standard. To help provide answers to these, the In-Vitro Release and Dissolution Testing (IVRDT) Community would like to organize an interactive event with the USP where a technical representative from the USP will introduce the DPVS and offer the latest update on implementation, protocols, timelines, etc. This representative will then be available to answer questions in a structured way from a panel representing a cross-section of our community or moderated questions from event attendees.

Learning Objectives:

What is the new USP DPVS Calibrator
How do I use it instead of the existing Prednisone
When does this mandatory validation change come into effect

Contributors

Mark Liddell, Ph.D.

Mark Liddell, Ph.D., Manager of Dosage Form Performance Laboratory for USP, leads the dosage form performance (DFP) laboratory at the Rockville headquarters of USP. The DFP laboratory is responsible for the overseeing the development and manufacture of performance verification test materials used to demonstrate the suitability of dissolution test apparatuses. He has worked for USP for more than 16 years. While at USP his work has focused on improving the reliability and reproducibility of compendial dissolution and drug release test methods. He has more than twenty-five years of experience conducting research focused on improving in vitro test methods for dosage forms and drug delivery systems. Mark earned his Bachelor of Science in Chemistry from Westminster College of Salt Lake City and his doctoral degree in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. Prior to joining USP Mark worked as a research assistant at the University of Cincinnati School of Pharmacy.

Thank you

Description

Contributors

Mark Liddell, Ph.D.