Research ArticleResearch
A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
Steven J. Novick, Elizabeth Christian, Erika Farmer and Max Tejada
PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 8-23; DOI: https://doi.org/10.5731/pdajpst.2019.011221
Steven J. Novick
1Department of Data Sciences and Quantitative Biology, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD; and
Elizabeth Christian
2Department of Bioassay Impurity and Quality, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Erika Farmer
2Department of Bioassay Impurity and Quality, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Max Tejada
2Department of Bioassay Impurity and Quality, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD

References
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- 4.↵U.S. Food and Drug Administration. Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics, 2015. FDA Web site. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf (accessed Jan 4, 2019).
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 1
January/February 2021
A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
Steven J. Novick, Elizabeth Christian, Erika Farmer, Max Tejada
PDA Journal of Pharmaceutical Science and Technology Jan 2021, 75 (1) 8-23; DOI: 10.5731/pdajpst.2019.011221
Jump to section
- Article
- Abstract
- 1. Introduction
- 2. Statistical Modeling
- 3. Example: Potency Bioassay
- 4. Detecting Atypical Data
- 5. Discussion
- Conflict of Interest
- Acknowledgments
- Supplementary Material 1: Data Tables
- Supplementary Material 2: Posterior/Prior Distributions
- Supplementary Material 3: Different Prior Distributions for the Transfer Study
- References
- Figures & Data
- References
- Info & Metrics
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