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

Author(s): Vivian Gray.

Journal Name: Recent Patents on Drug Delivery & Formulation

Volume 11 , Issue 1 , 2017

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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.

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Article Details

VOLUME: 11
ISSUE: 1
Year: 2017
Page: [3 - 4]
Pages: 2
DOI: 10.2174/1872211310666161117123632
Price: $58

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