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

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

Volume: 11 Issue: 1

Author(s): Vivian Gray

Affiliation:

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

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.

Cite this article as:

Gray Vivian, Addressing the Challenge of Developing a Physiologically Relevant Dissolution Test for Regulatory Purposes, Recent Patents on Drug Delivery & Formulation 2017; 11 (1) . https://dx.doi.org/10.2174/1872211310666161117123632