Zdrowie i gospodarka · 09/01/2009

FDA Releases Guidance on Harmonization of Pharmacopoeial Texts for Parenteral Preparations

The Food and Drug Administration (FDA) has made available a guidance document that outlines the results of the International Conference on Harmonisation (ICH) Q4B evaluation of the Test for Extractable Volume of Parenteral Preparations General Chapter, harmonized text from the United States, European, and Japanese pharmacopoeias, and provides recognition of the three pharmacopoeial methods by the three ICH regulatory regions.