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Dissolution Testing in Drug Product Development: Workshop Summary Report.

Andreas Abend1, David Curran2, Jesse Kuiper3

  • 1Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA. andreas_abend@merck.com.

The AAPS Journal
|January 29, 2019
PubMed
Summary
This summary is machine-generated.

This workshop explored advanced dissolution testing and translational modeling for patient-centric drug development. Key outcomes focus on implementing clinically relevant specifications and novel quality control methods.

Keywords:
biopredictivebiorelevantclinically relevant dissolutiondiscriminating powersurrogate for dissolution

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Regulatory Science

Background:

  • The pharmaceutical industry faces challenges in implementing novel dissolution testing methods.
  • Conventional dissolution testing requires enhancement for robust drug product understanding.
  • Bridging exploratory dissolution approaches with end-product quality control is crucial.

Purpose of the Study:

  • To summarize discussions on dissolution and translational modeling strategies.
  • To foster dialogue between industry and regulatory agencies on drug product development.
  • To explore the implementation of clinically relevant dissolution specifications.

Main Methods:

  • Summarized proceedings from a 3-day workshop.
  • Included podium presentations on experimental dissolution setups and surrogate test methods.
  • Incorporated breakout session discussions on terminology and testing approaches.

Main Results:

  • Highlighted challenges in using novel dissolution setups for quality control.
  • Identified opportunities to replace conventional testing with surrogate methods.
  • Addressed the need for an in vitro-in vivo link for specifications.

Conclusions:

  • Emphasized the importance of Quality by Design (QbD) and advanced manufacturing technologies.
  • Stressed the need for consistent terminology in dissolution science.
  • Outlined strategies for integrating exploratory dissolution with end-product testing.