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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustryStatistical Methods for CMC Applications

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical... [In this chapter, we provide statistical methods that are useful in CMC applications. Our goal is to provide a description of these methods without delving deeply into the theoretical aspects. References are provided for the reader who desires a more in depth understanding of the material.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustryStatistical Methods for CMC Applications

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Publisher
Springer International Publishing
Copyright
© Springer International Publishing AG 2017
ISBN
978-3-319-50184-0
Pages
11 –113
DOI
10.1007/978-3-319-50186-4_2
Publisher site
See Chapter on Publisher Site

Abstract

[In this chapter, we provide statistical methods that are useful in CMC applications. Our goal is to provide a description of these methods without delving deeply into the theoretical aspects. References are provided for the reader who desires a more in depth understanding of the material.]

Published: Feb 17, 2017

Keywords: Analysis of variance; Bayesian analysis; Confidence intervals; Data reporting; Data rounding; Data transformations; Dependent measures; Equivalence testing; Hypothesis testing; Interaction effects; LOQ values; Mixed models; Multiple regression; Nonlinear models; Non-normal data; Prediction intervals; Quadratic effects; Regression analysis; Residual analysis; Statistical consulting; Statistical intervals; Tolerance intervals; Visualization of data

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