This book examines statistical methods which might be critically vital to Chemistry, Manufacturing, and Management (CMC) actions. Statistical strategies are introduced with a deal with functions distinctive to the CMC in the pharmaceutical business.
The audience consists of statisticians and different scientists who’re accountable for performing statistical analyses inside a CMC setting. Fundamental statistical ideas are addressed in Chapter 2 adopted by functions to particular subjects associated to growth and manufacturing. The mathematical stage assumes an elementary understanding of statistical strategies. The flexibility to make use of Excel or statistical packages corresponding to Minitab, JMP, SAS, or R will present extra worth to the reader.
The motivation for this book got here from an American Affiliation of Pharmaceutical Scientists (AAPS) brief course on statistical strategies utilized to CMC functions introduced by 4 of the authors. One in all the course contributors requested us for reference book, and the solely book really useful was written over 20 years in the past by Chow and Liu (1995). We agreed newer book would serve a necessity in our business.
Since we started this undertaking, an edited book has been printed on the similar matter by Zhang (2016). The chapters in Zhang talk about statistical strategies for CMC in addition to drug discovery and nonclinical growth. We consider our book enhances Zhang by offering extra detailed statistical analyses and examples.
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