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Purpose and Description

The dissolution test is a primary quality control test which all products must pass to be on the market. With evolving dosage form types the dissolution test, or some may call the technology the in vitro release test, is constantly being improved or changed with newer equipment and methodology. Setting appropriate specifications for the test is a challenge for industry and the regulatory agencies. Harmonization of the dissolution test is an ongoing point of discussion, as is the calibration of the equipment. The in vitro and in vivo correlation is still a centerpiece for many discussions as to the ability of the test to predict bioequivalence.

The purpose of this focus group is to provide a forum for discussion across industry, regulatory agencies, and academia for development of useful and standardized methods to meet the challenges of new dosage forms and to improve or encourage innovation of new methodologies, provide a more in depth understanding of the IVIVC, and to encourage discussion of topics of interest.

Goals and Objectives

• Explore new technologies/equipment for in vitro release testing of novel dosage forms
• Explore in vitro release testing methods for dosage forms others that solid oral dosage forms
• Identify current method development problems and the associated dosage forms...
• Discussion of validation principles for new and standard methods
• Explore how the test may be more relevant to the human physiology
• Provide a forum for discussing the process for setting specifications
• Explore the use of dissolution testing in applying the BCS/biowaivers.
• Discuss the calibration parameters of all official apparatus.
• Harmonization of ICH and Pharmacopeias
• Statistics and modeling related to in vitro release and dissolution testing

As part of its global outreach imitative, AAPS dissolution focus group organized an AAPS-SFDA joint conference in Hangzhou, China on July 1-2, 2007. This conference was co-sponsored by AAPS and Zhejiang SFDA. Qingxi Wang, Vivian Gray, Lawrence Yu, Kailas Thakker, Rose Gao and Leonardo Allain attended this conference and gave speeches on various topics representing AAPS, with aim at providing training, sharing best practices and helping China to bridge with global pharmaceutical communities. The subjects covered were the generic drug NDA filing and approval process, the added value of the dissolution test utilizing the concepts of BCS, method development for novel dosage forms and semi-solids, and an overview of dissolution equipment and sources of error. Approximately 160 representatives from SFDA and industry attended this conference. The general feedback from attendees was very positive. The AAPS dissolution focus group will organize the similar forum at other emerging market in 2008 and years to come.

Presentations

• AAPS Workshop on Role of Dissolution in QbD and Drug Product Life Cycle, co-sponsored with the FDA, April 2008
• IVRDTFG Face-to-Face Meeting Notes, April 2007
• IVRDTFG Face-to-Face Meeting Slides, April 2007
• Highlights from the 2006 AAPS Annual Meeting
• Highlights from the 2005 AAPS Annual Meeting
• IVRDTFG Highlights, April 2005
• FDA Advisory Panel Presentations, May 3, 2005
• FDA Advisory Panel Briefing Document, May 3, 2005
• Future Challenges of the Dissolution/Performance Test
• Bioequivalence & In Vitro-In Vivo Correlations
• IVRD Meeting April 2005_Method Validations – Worrell
• IVRD Meeting April 2005_Method Challenges – Vivan
• IVRD Meeting April 2005_ Method Challenges – Mirza
• IVRD Meeting April 2005_Validation Strategies – Salt

Resources

• Dissolution Technologies
• Dissolution Testing of Immediate Release Solid Dosage forms
• Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
• SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
• SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
• Analytical Procedures and Methods Validation
• Drug Product: Chemistry, Manufacturing, and Controls Information
• FIP/AAPS Guidelines to Dissolution/in Vitro Release Testing of Novel/Special Dosage Forms

Steering Committee Teleconference Minutes

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