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FDA's Final Guideline Standardizes Dissolution Testing For Highly Soluble Drugs

 
• By Joanne S. Eglovitch

FDA guidance aims to establish uniform dissolution testing methods for highly soluble immediate-release solid oral dosage forms.

Dissolution Testing In Pharmaceuticals

US FDA’s final guidance spells out how to use standard dissolution methods for new drug applications and abbreviated new drug applications for highly soluble immediate-release solid oral dosage forms. FDA said that the guidance should also facilitate the agency’s review of the data submitted in applications.

The guidance also describes when a standard release test may be used in lieu of extensive method development and acceptance...

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