IPEC e-newsletter - Excipients Insight June 2014 - 30-06-14


Inside this issue


In brief: FDA adopts ICH document on dose uniformity

The US Food and Drug Administration (FDA) has issued a guidance document that aims to clarify the International Conference on Harmonisation's (ICH) Q4B guideline on the use of pharmacopoeial texts.

The document - entitled Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter  -  is "intended to avoid redundant testing by industry," according to the agency.

The guidance notes that the official pharmacopoeial texts of the three ICH regions - i.e. Ph. Eur. 2.9.40. Uniformity of Dosage Units; JP 6.02 Uniformity of Dosage Units; and USP General Chapter <905> Uniformity of Dosage Units - can be used as interchangeable in the ICH regions subject to certain conditions.




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