Parallelism in Practice: Approaches to Parallelism in Bioassays

References

1. 1.↵
   1. Finney D. J.

   Statistical Method in Biological Assay, 2nd ed.; Charles Griffin and Co.: London, 1964.
2. 2.↵
   Council of Europe. Statistical Analysis of Results of Biological Assays and Tests. In European Pharmacopoeia, 7th ed.; Council of Europe: Strasbourg, France, 2011; pp 551–579.
3. 3.↵
   1. Callahan J. D.,
   2. Sajjadi N. C.

   Testing the null hypothesis for a specified difference—the right way to test for parallelism. Bioprocessing J. 2003, 2, 71–77.

   OpenUrl
4. 4.↵
   1. Hauck W. W.,
   2. Capen R. C.,
   3. Callahan J. D.,
   4. De Muth J. E.,
   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.

   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.↵
   United States Pharmacopeial Convention. <1032> Design and Development of Biological Assays. In First Supplement to USP 35-NF 30; United States Pharmacopeial Convention: Rockville, MD, 2012; pp 5160–5174.
7. 7.↵
   United States Pharmacopeial Convention. <1033> Biological Assay Validation. In First Supplement to USP 35-NF 30; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2012; pp 5174–5185.
8. 8.↵
   United States Pharmacopeial Convention. <1034> Analysis of Biological Assays. In First Supplement to USP 35-NF 30; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2012; pp 5186–5200.
9. 9.↵
   1. Gottschalk P. G.,
   2. Dunn J. R.

   The five-parameter logistic: a characterization and comparison with the four-parameter logistic. Anal. Biochem. 2005, 343 (1), 54–65.

   OpenUrlCrossRefPubMedWeb of Science
10. 10.↵
    1. McCullagh P.,
    2. Nelder J. A.

    Generalized Linear Models, 2nd ed.; Chapman and Hall: London, 1989.
11. 11.↵
    1. Jonkman J. N.,
    2. Sidik K.

    Equivalence testing for parallelism in the four-parameter logistic model. J. Biopharm. Stat. 2009, 19 (5), 818–837.

    OpenUrlPubMed
12. 12.↵
    1. Yang H.,
    2. Zhang L.

    Evaluations of parallelism testing methods using ROC analysis. Stat. Biopharm. Res. 2012, 4 (2), 162–173.

    OpenUrl