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Recent Patents on Drug Delivery & Formulation


ISSN (Print): 1872-2113
ISSN (Online): 2212-4039

Opinion Article

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

Author(s): Vivian Gray

Volume 11, Issue 1, 2017

Page: [3 - 4] Pages: 2

DOI: 10.2174/1872211310666161117123632

Price: $65


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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