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Research ArticleResearch

Assessing Similarity in Bioanalytical Methods

Jason J. Z. Liao, Yu Tian and Robert C. Capen
PDA Journal of Pharmaceutical Science and Technology January 2011, 65 (1) 55-62;
Jason J. Z. Liao
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  • For correspondence: Jason.Liao@tevausa.com
Yu Tian
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Robert C. Capen
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References

  1. 1.↵
    1. Finney D. J.
    Statistical Method in Biological Assay, 3rd ed.; C. Griffin: London, 1978.
    Google Scholar
  2. 2.↵
    1. Yang H.,
    2. Zhang L.,
    3. Cho I.
    Evaluation of parallelism testing methods in immunoassay. ASA Proceedings on Biometrics Section (CD-ROM) 2006, 456–460.
    Google Scholar
  3. 3.↵
    1. Hauck W. W.,
    2. Capen R. C.,
    3. Callahan J. D.,
    4. De M. J.,
    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 TextGoogle Scholar
  4. 4.↵
    1. Hauck W. W.,
    2. Singer R.,
    3. Callahann L. N.
    Summary of planned revisions to design and analysis of biological assays 〈111〉. Pharmacopeial Forum 2007, 33 (3), 580–581.
    OpenUrlGoogle Scholar
  5. 5.↵
    1. Callhan J.,
    2. Sajjadi N.
    Testing the null hypothesis for a specified difference—the right way to test for parallelism. Bioprocessing Journal 2003, Mar/Apr, 1–6.
    Google Scholar
  6. 6.↵
    1. Chow S. C.
    1. Schofield T. L.
    (2000), Assay Validation. In Encyclopedia of Biopharamceutical Statistics. (Chow S. C. ed.), 21–30. Marcel Dekker: New York.
    Google Scholar
  7. 7.↵
    1. Draper N. R.,
    2. Smith H.
    Applied Regression Analysis, 3rd ed.; Wiley series in probability and statistics: Texts and references section. An introduction to nonlinear estimation. Wiley: New York, 1998.
    Google Scholar
  8. 8.↵
    1. Dunn J. R.
    Comparison of Methods Used to Measure Parallelism. IBC Biological Assay Development & Validation Conference, San Francisco, CA, May 14–16, 2008.
    Google Scholar
  9. 9.↵
    1. Wood E. C.
    The theory of certain analytical procedures, with particular reference to micro-biological assays. Analyst (London), 1946, 71, 1–14.
    OpenUrlPubMedGoogle Scholar
  10. 10.↵
    1. Dmitrienko A.,
    2. Chuang-Stein C.,
    3. D'Agostino R.
    1. Boulanger B.,
    2. Devanaryan V.,
    3. Dewe W.,
    4. Smith W.
    Chapter 4. Statistical Considerations in Analytical Method Validation. In Pharmaceutical Statistics Using SAS®: A Practical Guide; Dmitrienko A., Chuang-Stein C., D'Agostino R., Eds.; SAS Institute Inc.: Cary, NC, 2007; pp 69–96.
    Google Scholar
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 65 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 1
January/February 2011
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Assessing Similarity in Bioanalytical Methods
Jason J. Z. Liao, Yu Tian, Robert C. Capen
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 55-62;
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    • 1. Introduction
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Assessing Similarity in Bioanalytical Methods
Jason J. Z. Liao, Yu Tian, Robert C. Capen
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 55-62;

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