Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry
DOWNLOAD
Download Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry
DOWNLOAD
Author : Richard K. Burdick
language : en
Publisher: Springer
Release Date : 2017-02-14
Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry written by Richard K. Burdick and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-14 with Medical categories.
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.
Nonclinical Statistics For Pharmaceutical And Biotechnology Industries
DOWNLOAD
Author : Lanju Zhang
language : en
Publisher: Springer
Release Date : 2016-01-13
Nonclinical Statistics For Pharmaceutical And Biotechnology Industries written by Lanju Zhang and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-13 with Medical categories.
This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
Statistics For Biotechnology Process Development
DOWNLOAD
Author : Todd Coffey
language : en
Publisher: CRC Press
Release Date : 2018-05-16
Statistics For Biotechnology Process Development written by Todd Coffey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-16 with Mathematics categories.
Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.
Basic Statistics And Pharmaceutical Statistical Applications
DOWNLOAD
Author : James E. De Muth
language : en
Publisher: CRC Press
Release Date : 2014-04-28
Basic Statistics And Pharmaceutical Statistical Applications written by James E. De Muth and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-28 with Mathematics categories.
Building on its best-selling predecessors, Basic Statistics and Pharmaceutical Statistical Applications, Third Edition covers statistical topics most relevant to those in the pharmaceutical industry and pharmacy practice. It focuses on the fundamentals required to understand descriptive and inferential statistics for problem solving. Incorporating
The Management Of Chemical Process Development In The Pharmaceutical Industry
DOWNLOAD
Author : Derek Walker
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-03
The Management Of Chemical Process Development In The Pharmaceutical Industry written by Derek Walker and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-03 with Medical categories.
Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.
Biocatalysis For The Pharmaceutical Industry
DOWNLOAD
Author : Junhua (Alex) Tao
language : en
Publisher: John Wiley & Sons
Release Date : 2009-07-23
Biocatalysis For The Pharmaceutical Industry written by Junhua (Alex) Tao and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-07-23 with Science categories.
Biocatalysis is rapidly evolving into a key technology for the discovery and production of chemicals, especially in the pharmaceutical industry, where high yielding chemo-, regio-, and enantioselective reactions are critical. Taking the latest breakthroughs in genomics and proteomics into consideration, Biocatalysis for the Pharmaceutical Industry concisely yet comprehensively discusses the modern application of biocatalysis to drug discovery, development, and manufacturing. Written by a team of leading experts, the book offers deep insight into this cutting edge field. Covers a wide range of topics in a systematic manner with an emphasis on industrial applications Provides a thorough introduction to the latest biocatalysts, modern expression hosts, state-of-the-art directed evolution, high throughput screening, and bioprocess engineering Addresses frontier subjects such as emerging enzymes, metabolite profiling, combinatorial biosynthesis, metabolic engineering, and autonomous enzymes for the synthesis and development of chiral molecules, drug metabolites, and semi-synthetic medicinal compounds and natural product analogs Highlights the impact of biocatalysis on green chemistry Contains numerous graphics to illustrate concepts and techniques Biocatalysis for the Pharmaceutical Industry is an essential resource for scientists, engineers, and R&D policy makers in the fine chemical, pharmaceutical, and biotech industries. It is also an invaluable tool for academic researchers and advanced students of organic and materials synthesis, chemical biology, and medicinal chemistry.
Applied Statistics In The Pharmaceutical Industry
DOWNLOAD
Author : Steven P. Millard
language : en
Publisher: Springer
Release Date : 2010-12-01
Applied Statistics In The Pharmaceutical Industry written by Steven P. Millard and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-01 with Medical categories.
Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.
The Chemical And Pharmaceutical Industry In China
DOWNLOAD
Author : G. Festel
language : en
Publisher: Springer Science & Business Media
Release Date : 2005-12-05
The Chemical And Pharmaceutical Industry In China written by G. Festel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-12-05 with Business & Economics categories.
A detailed examination of China’s increasingly important chemical and pharmaceutical industry. Numerous case studies describe how western companies, such as BASF, Bayer, Bicoll, Ciba, Degussa, DSM and Novartis are managing their market entry in China.
Bayesian Methods In Pharmaceutical Research
DOWNLOAD
Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-15
Bayesian Methods In Pharmaceutical Research written by Emmanuel Lesaffre and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-15 with Medical categories.
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.
Statistics For Biotechnology Process Development
DOWNLOAD
Author : Todd Coffey
language : en
Publisher: CRC Press
Release Date : 2018-05-16
Statistics For Biotechnology Process Development written by Todd Coffey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-16 with Mathematics categories.
Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.