Validation Strategies for InVivo Dissolution Test Methods

1
Validation Strategies for In-Vivo Dissolution
Test Methods

• AAPS In-Vitro Dissolution Focus Group Meeting
  29-Apr-2005

2
Vision Statement

• We will employ dissolution test methods that
  provide meaningful scientific data and yield
  appropriate decisions for pharmaceutical
  formulation development and for the release of
  pharmaceutical materials to assure their safety
  and effectiveness.

3
Goals and Objectives

• Agree on strategies for developing dissolution
  test methods.
• Establish minimum standards to ensure that the
  test methods are accurate, robust, and provide
  meaningful results.
• The standards can be implemented with reasonable
  resource investment.

4
Todays Situation

• Dissolution testing is to fulfill perceived
  regulatory requirements
• Test results often lack of in-vivo correlation or
  bio-relevance
• Lack of desired profile or rate of release
• Often strive for 100 release

5
Physical Test
Dissolution is a physical test to characterize
how drug is released from a dosage form. We
employ analytical measurements and a clock to
determine rates of release. Hence, it makes
sense to compartmentalize the two.
6
Recommendation

• Develop strategies for developing and validating
  dissolution test methods
• Compartmentalize (where appropriate) the physical
  test and the analytical test
• What to do next
• Identify action items