Zdrowie i gospodarka · 05/04/2010

FDA Releases Guidance on Harmonization of Pharmacopoeial Texts for Use in ICH Regions

The Food and Drug Administration (FDA) has made available a guidance document that outlines the results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from the United States, European, and Japanese pharmacopoeias, and recognizes the interchangeability between local regional pharmacopoeias to facilitate a common testing strategy across ICH regulatory regions.