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.
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.
Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
Encyclopedia of Biopharmaceutical Statistics - Four Volume Set - 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 Encyclopedia of Biopharmaceutical Statistics - Four Volume Set write by Shein-Chung Chow. This book was released on 2018-09-03. Encyclopedia of Biopharmaceutical Statistics - Four Volume Set available in PDF, EPUB and Kindle. Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Biosimilar Clinical Development: Scientific Considerations and New Methodologies
Biosimilar Clinical Development: Scientific Considerations and New Methodologies - 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 Biosimilar Clinical Development: Scientific Considerations and New Methodologies write by Kerry B. Barker. This book was released on 2016-11-25. Biosimilar Clinical Development: Scientific Considerations and New Methodologies available in PDF, EPUB and Kindle. Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
Bayesian Methods in Pharmaceutical Research
Bayesian Methods in Pharmaceutical Research - 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 Bayesian Methods in Pharmaceutical Research write by Emmanuel Lesaffre. This book was released on 2020-04-15. Bayesian Methods in Pharmaceutical Research available in PDF, EPUB and Kindle. 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.
