Nonclinical Statistics for Pharmaceutical and Biotechnology Industries - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Nonclinical Statistics for Pharmaceutical and Biotechnology Industries write by Lanju Zhang. This book was released on 2016-01-13. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries available in PDF, EPUB and Kindle. 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
Statistics for Biotechnology Process Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Statistics for Biotechnology Process Development write by Todd Coffey. This book was released on 2018-05-16. Statistics for Biotechnology Process Development available in PDF, EPUB and Kindle. 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.
Applied Statistics in the Pharmaceutical Industry
Applied Statistics in the Pharmaceutical Industry - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Applied Statistics in the Pharmaceutical Industry write by Steven P. Millard. This book was released on 2001-07-01. Applied Statistics in the Pharmaceutical Industry available in PDF, EPUB and Kindle. 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.
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing write by Harry Yang. This book was released on 2016-11-30. Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing available in PDF, EPUB and Kindle. The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.
Statistical Thinking for Non-Statisticians in Drug Regulation
Statistical Thinking for Non-Statisticians in Drug Regulation - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Statistical Thinking for Non-Statisticians in Drug Regulation write by Richard Kay. This book was released on 2022-11-29. Statistical Thinking for Non-Statisticians in Drug Regulation available in PDF, EPUB and Kindle. STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.
