Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry - Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky & Lanju Zhang

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

By Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky & Lanju Zhang

  • Release Date: 2017-02-14
  • Genre: Medical

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry.  

The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods.  The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader.

The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors.  One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995).  We agreed that a more recent book would serve a need in our industry.  

Since we began this project, an edited book has been published on the same topic by Zhang (2016).  The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development.  We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Comments:

12 Comments
Taylor Mackenzie
Amazing! I love this site
Aston Ayers
Only Signup is easy and free, finally I can read this book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry with good quality. Thank you!
Ashley Ann
Been waiting to download this book for months. and finally came out too
Cheryl Lynn
This book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry is very nice, with quick read and download
Erin Cochran Cole
Great selection and quality is better than many Book Store, no kidding.
Kyle Magner
yes, i am also through this to download books
Eric Mn
Yes this really works! Just got my free account
Terry Barnes
One of the best book I've seen this year!
Pastor Shahuano
Excited, Happy Reading guys !!!
Laura Velez Garcia
Thanks, I'm so glad to be reading this book
Wouter van der Giessen
Laura Velez Garcia yes same me too
Janet McCann
Sign up was really easy. Less than 1 minute I was hooked up