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Research ArticleResearch

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

Harry Yang
PDA Journal of Pharmaceutical Science and Technology January 2013, 67 (1) 53-62; DOI: https://doi.org/10.5731/pdajpst.2013.00902
Harry Yang
MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
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References

  1. 1.↵
    U.S. FDA Guidance for Industry on Process Validation: General Principles and Practices, 2011.
  2. 2.↵
    ICH Q8(R2). Pharmaceutical Development, 2006.
  3. 3.↵
    ICH Q9. Quality Risk Management, 2007.
  4. 4.↵
    ICH Q10. Pharmaceutical Quality Systems, 2007.
  5. 5.↵
    ICH Q11. Concept Paper, 2011.
  6. 6.↵
    FDA Guideline on General Principles of Process Validation. FDA: Rockville, MD, May, 1987.
  7. 7.↵
    1. Berger J. O
    . Statistical Decision Theory and Bayesian Analysis, 2nd ed.; Springer: New York, 2010.
  8. 8.↵
    1. Bayes T. R
    . An essay towards solving a problem in the doctrine of chances. Philos Trans. Roy. Soc. London 1763, 53, 370–418. Reprinted with an introduction by Barnard, G. Biometrika 1958, 45, 293–315.
    OpenUrlCrossRef
  9. 9.↵
    1. Spiegelhalter D. J.,
    2. Abrams K. R.,
    3. Myles J. P
    . Bayesian Approaches to Clinical Trials and Health-Care Evaluation; Wiley: Hoboken, NJ, 2004.
  10. 10.↵
    1. Hahn G. J.,
    2. Nelson W. A
    . survey of prediction intervals and their applications. J. Qual. Technol. 1973, 5 (4), 178– 188.
    OpenUrl
  11. 11.↵
    1. Agresti A
    . On logit confidence intervals for the odds ratio with small samples. Biometrics 1999, 55 (2), 597– 602.
    OpenUrlCrossRefPubMedWeb of Science
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PDA Journal of Pharmaceutical Science and Technology: 67 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 1
January/February 2013
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How Many Batches Are Needed for Process Validation under the New FDA Guidance?
Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 53-62; DOI: 10.5731/pdajpst.2013.00902

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How Many Batches Are Needed for Process Validation under the New FDA Guidance?
Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 53-62; DOI: 10.5731/pdajpst.2013.00902
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Keywords

  • Bayesian analysis
  • Life cycle approach
  • Process validation
  • Sample size
  • Validation batch

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