Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 13: Bulk Density and Tapped Density of Powders General Chapter.

摘要

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. This annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).