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A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes

Authors :
Lingmin Zeng
Binbing Yu
Harry Yang
Source :
Statistics in Biopharmaceutical Research. 10:158-165
Publication Year :
2018
Publisher :
Informa UK Limited, 2018.

Abstract

To ensure the safety, efficacy, and quality, regulatory authorities require that multiple critical quality attributes of a drug must conform to certain specification limits. Manufacturers m...

Details

ISSN :
19466315
Volume :
10
Database :
OpenAIRE
Journal :
Statistics in Biopharmaceutical Research
Accession number :
edsair.doi...........3df71d8a0d8eacdcde176519e13ea8f4