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.
Recent Patents on Drug Delivery & Formulation
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.
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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
DOI https://dx.doi.org/10.2174/1872211310666161117123632 |
Print ISSN 1872-2113 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-4039 |