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...
Burdick, Richard K.; LeBlond, David J.; Pfahler, Lori B.; Quiroz, Jorge; Sidor, Leslie; Vukovinsky, Kimberly; Zhang, Lanju
2017-02-17 00:00:00
[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.]
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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustryStatistical Methods for CMC Applications
[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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