A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays

Reference

1. 1.↵
   Chapter 5.3. Statistical Analysis and Results of Biological Assays and Tests. In European Pharmacopoeia 7.0; 2008, pp 551–579.
2. 2.↵
   <1032> Design and Development of Biological Assays. In USP 35-NF 30; USP: Rockville, MD, 2012; pp 5160–5174.
3. 3.↵
   1. Healy M. J. R.

   Statistical Analysis of Radioimmunoassay Data. Biochem. J. 1972, 130 (1), 207–210.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Hauck W.W.,
   2. Capen R. C.,
   3. Callahan J. D.,
   4. Muth J. E. D.,
   5. Hsu H.,
   6. Lansky D.,
   7. Sajjadi N. C.,
   8. Seaver S. S.,
   9. Singer R. R.,
   10. Weisman D.

   Assessing Parallelism Prior to Determining Relative Potency. PDA J. Pharm. Sci. Technol. 2005, 59 (2), 127–137.

   OpenUrlAbstract/FREE Full Text
5. 5.↵
   1. Gottschalk P. G.,
   2. Dunn J. R.

   Measuring Parallelism, Linearity, and Relative Potency in Bioassay and Immunoassay Data. J. Biopharm. Stat. 2005, 15 (3), 437–463.

   OpenUrlCrossRefPubMed
6. 6.
   1. Prentice R. L. A.

   A Generalization of the Probit and Logit Methods for Dose-Response Curves. Biometrics 1976, 32 (4), 761–768.

   OpenUrlCrossRefPubMedWeb of Science
7. 7.
   1. Finney D. J.

   Statistical Methods in Biological Assays, 3rd ed.; Charles Griffin: London, 1978.
8. 8.
   1. Bates D. M.,
   2. Watts D. G.

   Nonlinear Regression Analysis and Its Applications. Wiley: New York, 1988.