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A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes
- 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...
- Subjects :
- Statistics and Probability
Mixed model
Computer science
media_common.quotation_subject
Bayesian probability
Pharmaceutical Science
01 natural sciences
010104 statistics & probability
03 medical and health sciences
0302 clinical medicine
Risk analysis (engineering)
Quality (business)
030212 general & internal medicine
0101 mathematics
Critical quality attributes
media_common
Subjects
Details
- ISSN :
- 19466315
- Volume :
- 10
- Database :
- OpenAIRE
- Journal :
- Statistics in Biopharmaceutical Research
- Accession number :
- edsair.doi...........3df71d8a0d8eacdcde176519e13ea8f4