Issue Date: May 23, 2013
Issued by: Center for Biologics Evaluation and Research
Topic(s):
Status: Final
Annex 13 Bulk Density and Tapped Density of Powders General Chapter
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.
Download the Guidance Document
