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Mathematical and Statistical Skills in the Biopharmaceutical Industry

2019-07-15 Business & Economics
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Release : 2019-07-15
Genre : Business & Economics
Kind : eBook
Book Rating : 802/5 ( reviews)

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Book Synopsis Mathematical and Statistical Skills in the Biopharmaceutical Industry by : Arkadiy Pitman

Download or read book Mathematical and Statistical Skills in the Biopharmaceutical Industry written by Arkadiy Pitman. This book was released on 2019-07-15. Available in PDF, EPUB and Kindle. Book excerpt: Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Mathematical and Statistical Skills in the Biopharmaceutical Industry

2019-07-15 Business & Economics
Download Mathematical and Statistical Skills in the Biopharmaceutical Industry PDF Online Free

Author :
Release : 2019-07-15
Genre : Business & Economics
Kind : eBook
Book Rating : 237/5 ( reviews)

GET EBOOK


Book Synopsis Mathematical and Statistical Skills in the Biopharmaceutical Industry by : Arkadiy Pitman

Download or read book Mathematical and Statistical Skills in the Biopharmaceutical Industry written by Arkadiy Pitman. This book was released on 2019-07-15. Available in PDF, EPUB and Kindle. Book excerpt: Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Applied Statistics in the Pharmaceutical Industry

2013-11-09 Medical
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Release : 2013-11-09
Genre : Medical
Kind : eBook
Book Rating : 662/5 ( reviews)

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Book Synopsis Applied Statistics in the Pharmaceutical Industry by : Steven P. Millard

Download or read book Applied Statistics in the Pharmaceutical Industry written by Steven P. Millard. This book was released on 2013-11-09. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

2017-02-14 Medical
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Release : 2017-02-14
Genre : Medical
Kind : eBook
Book Rating : 860/5 ( reviews)

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Book Synopsis Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by : Richard K. Burdick

Download or read book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry written by Richard K. Burdick. This book was released on 2017-02-14. Available in PDF, EPUB and Kindle. Book excerpt: 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

2016-01-13 Medical
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Release : 2016-01-13
Genre : Medical
Kind : eBook
Book Rating : 583/5 ( reviews)

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Book Synopsis Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by : Lanju Zhang

Download or read book Nonclinical Statistics for Pharmaceutical and Biotechnology Industries written by Lanju Zhang. This book was released on 2016-01-13. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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