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In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop
Sandra Suarez-Sharp1,2, Andreas Abend3, Thomas Hoffelder4
1Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
The AAPS Journal
|May 21, 2020
Summary
Dissolution similarity testing is crucial for drug product decisions, but regulatory requirements vary. Harmonizing these methods, including the f2 factor, is essential for global pharmaceutical standards.
Area of Science:
- Pharmaceutical Sciences
- Regulatory Science
- Biostatistics
Background:
- Dissolution similarity testing is vital for drug product life cycle management and regulatory decisions.
- Current regulatory guidance incorporates mathematical approaches for dissolution profile similarity assessment.
- Divergent requirements for statistical methods like the f2 factor exist across different regulatory agencies.
Purpose of the Study:
- To highlight current practices in in vitro dissolution similarity assessment.
- To promote global harmonization of dissolution profile similarity evaluation methods.
- To discuss the 'what, how, and when' of dissolution similarity assessment in supporting drug product quality.
Main Methods:
- Summarized key points from podium presentations and breakout sessions of a dedicated workshop.
- Contrasted advantages and disadvantages of various statistical methods for similarity evaluation.
- Emphasized the importance of experimental design and clinically relevant specifications.
Main Results:
- Identified significant divergence in requirements for applying the f2 factor and other statistical approaches.
- Highlighted the critical role of experimental design in successful similarity evaluations.
- Underscored the need for aligning similarity evaluation with clinically relevant specifications.
Conclusions:
- There is a clear need for global harmonization in dissolution profile similarity assessment.
- Developing a robust, non-prescriptive decision tree is a key step towards harmonization.
- Standardized approaches will enhance the scientific basis for drug product quality decisions.
