Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical...

Area of Science:

• Pharmaceutical Sciences
• Drug Development
• Regulatory Science

Background:

• Dissolution testing has transitioned from a simple end-product release test to a sophisticated tool over the last 30 years.
• The IQ Consortium Dissolution Working Group, representing various industry companies, provides current perspectives on its application.
• Modern drug development increasingly utilizes dissolution testing across the entire product lifecycle.

Purpose of the Study:

• To summarize the IQ Consortium Dissolution Working Group's views on the multifaceted roles of dissolution testing.
• To define and explain various dissolution approaches and their interrelationships.
• To discuss the application of dissolution testing in modern drug development and lifecycle management.

Main Methods:

• The article reviews established and emerging dissolution testing methodologies.
• It categorizes and defines quality control, biorelevant, and clinically relevant dissolution methods.
• The discussion encompasses the strategic deployment of these methods throughout drug product development.

Main Results:

• Dissolution testing is now a comprehensive set of tools applicable at multiple stages of a pharmaceutical product's life cycle.
• Different dissolution methods serve distinct purposes with unique advantages and limitations.
• Understanding these methods is crucial for effective drug development and lifecycle management.

Conclusions:

• Dissolution testing plays a critical role beyond end-product release, impacting development, registration, and commercialization.
• Biorelevant and clinically relevant dissolution methods offer enhanced insights into drug performance.
• Strategic application of diverse dissolution testing approaches optimizes pharmaceutical product lifecycle management.