Review ArticleReview
Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation
Binbing Yu and Harry Yang
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 297-305; DOI: https://doi.org/10.5731/pdajpst.2016.007088
Binbing Yu
MEDIMMUNE LLC, GAITHERSBURG, MD
Harry Yang
MEDIMMUNE LLC, GAITHERSBURG, MD

Reference
- 1.↵USP. General Chapter 〈1033〉 Biological Assay Validation. The United States Pharmacopeia and The National Formulary; United States Pharmacopeial Convention: Rockville, MD, 2010.
- 2.↵
- Singer R.,
- Lansky D.,
- Hauck W.
- 3.↵FDA Draft Guidance for Industry Bioanalytical Method Validation (No. 78 FR 56718), 2013.
- 4.↵
- Kirkwood T. B.
- 5.↵
- Bohidar N. R.
- 6.↵
- Bohidar N. R.
- 7.↵
- Kirkwood T. B.
- 8.↵
- Reed G. F.,
- Lynn F.,
- Meade B. D.
- 9.↵
- Tan C. Y.
- 10.↵
- Gates I. V.,
- Zhang Y.,
- Shambaugh C.,
- Bauman M. A.,
- Tan C.,
- Bodmer J. L.
- 11.↵
- Attfield M. D.,
- Hewett P.
- 12.
- Steele J. M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation
Binbing Yu, Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 297-305; DOI: 10.5731/pdajpst.2016.007088
Jump to section
- Article
- Abstract
- Introduction
- Statistical Notes
- Simulation
- Estimation of Intermediate Precision
- A Simple Example
- Discussion
- Conflict of Interest Declaration
- Acknowledgements
- Appendix 1. Estimates of Mean and Variance Estimates for the Three Proposed Methods
- Appendix 2. Setting the Location and Scale Parameters ξ and ω for Simulation
- Appendix 3. Asymptotic Distribution of Geometric Mean of Y1, Y2, … , Yn
- Reference
- Figures & Data
- References
- Info & Metrics
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