Zdrowie i gospodarka · 28/05/2013

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

The FDA has made available a guidance document that outlines the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from the US, European, and Japanese pharmacopoeias, aiming to promote a common testing strategy across ICH regulatory regions.