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Addressing the Challenge of Developing a Physiologically Relevant Dissolution Test for Regulatory Purposes

[ Vol. 11 , Issue. 1 ]

Author(s):

Vivian Gray   Pages 3 - 4 ( 2 )

Abstract:


The challenge of developing a physiologically relevant dissolution test to satisfy regulatory agencies has pushed drug manufacturers to engage in “design of experiment” method development, which helps manufacturers address variability, dissolution medium, and surfactant use-all of which will influence dissolution.

Keywords:

Dissolution, design of experiments, variability, FDA guidances, method development, f2.

Affiliation:

Dissolution Technologies, Inc. Hockessin, Delaware ,DE



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