Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry

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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 Book PDF

Author : Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
Publisher : Springer
Page : 379 pages
File Size : 45,6 Mb
Release : 2017-02-14
Category : Medical
ISBN : 9783319501864

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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 Pdf

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

Lanju Zhang
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries Book PDF

Author : Lanju Zhang
Publisher : Springer
Page : 698 pages
File Size : 42,7 Mb
Release : 2016-01-13
Category : Medical
ISBN : 9783319235585

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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by Lanju Zhang Pdf

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.

Basic Statistics and Pharmaceutical Statistical Applications

James E. De Muth
Basic Statistics and Pharmaceutical Statistical Applications Book PDF

Author : James E. De Muth
Publisher : CRC Press
Page : 838 pages
File Size : 54,8 Mb
Release : 2014-04-28
Category : Mathematics
ISBN : 9781466596740

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Basic Statistics and Pharmaceutical Statistical Applications by James E. De Muth Pdf

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

Statistics for Biotechnology Process Development

Todd Coffey,Harry Yang
Statistics for Biotechnology Process Development Book PDF

Author : Todd Coffey,Harry Yang
Publisher : CRC Press
Page : 358 pages
File Size : 40,5 Mb
Release : 2018-05-16
Category : Mathematics
ISBN : 9781498721417

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Statistics for Biotechnology Process Development by Todd Coffey,Harry Yang Pdf

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.

Bayesian Methods in Pharmaceutical Research

Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger
Bayesian Methods in Pharmaceutical Research Book PDF

Author : Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger
Publisher : CRC Press
Page : 547 pages
File Size : 48,8 Mb
Release : 2020-04-15
Category : Medical
ISBN : 9781351718677

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Bayesian Methods in Pharmaceutical Research by Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger Pdf

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

Todd Coffey,Harry Yang
Statistics for Biotechnology Process Development Book PDF

Author : Todd Coffey,Harry Yang
Publisher : CRC Press
Page : 402 pages
File Size : 48,5 Mb
Release : 2018-05-16
Category : Mathematics
ISBN : 9781351646345

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Statistics for Biotechnology Process Development by Todd Coffey,Harry Yang Pdf

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

Steven P. Millard,Andreas Krause
Applied Statistics in the Pharmaceutical Industry Book PDF

Author : Steven P. Millard,Andreas Krause
Publisher : Springer
Page : 0 pages
File Size : 42,7 Mb
Release : 2010-12-01
Category : Medical
ISBN : 144193166X

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Applied Statistics in the Pharmaceutical Industry by Steven P. Millard,Andreas Krause Pdf

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.

Specification of Drug Substances and Products

Christopher M. Riley,Thomas W. Rosanske,George L. Reid
Specification of Drug Substances and Products Book PDF

Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
Publisher : Elsevier
Page : 696 pages
File Size : 48,7 Mb
Release : 2020-07-23
Category : Science
ISBN : 9780081028254

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Specification of Drug Substances and Products by Christopher M. Riley,Thomas W. Rosanske,George L. Reid Pdf

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Bayesian Analysis with R for Drug Development

Harry Yang,Steven Novick
Bayesian Analysis with R for Drug Development Book PDF

Author : Harry Yang,Steven Novick
Publisher : CRC Press
Page : 310 pages
File Size : 42,5 Mb
Release : 2019-06-26
Category : Mathematics
ISBN : 9781351585941

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Bayesian Analysis with R for Drug Development by Harry Yang,Steven Novick Pdf

Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

Biosimilars

Hiten J. Gutka,Harry Yang,Shefali Kakar
Biosimilars Book PDF

Author : Hiten J. Gutka,Harry Yang,Shefali Kakar
Publisher : Springer
Page : 709 pages
File Size : 46,5 Mb
Release : 2018-12-13
Category : Medical
ISBN : 9783319996806

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Biosimilars by Hiten J. Gutka,Harry Yang,Shefali Kakar Pdf

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Dosage Form Design Parameters

Anonim
Dosage Form Design Parameters Book PDF

Author : Anonim
Publisher : Academic Press
Page : 810 pages
File Size : 53,5 Mb
Release : 2018-07-25
Category : Medical
ISBN : 9780128144220

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Dosage Form Design Parameters by Anonim Pdf

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Statistics In the Pharmaceutical Industry, 3rd Edition

Charles Ralph Buncher,Jia-Yeong Tsay
Statistics In the Pharmaceutical Industry 3rd Edition Book PDF

Author : Charles Ralph Buncher,Jia-Yeong Tsay
Publisher : CRC Press
Page : 606 pages
File Size : 49,7 Mb
Release : 1993-11-17
Category : Mathematics
ISBN : 0824790731

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Statistics In the Pharmaceutical Industry, 3rd Edition by Charles Ralph Buncher,Jia-Yeong Tsay Pdf

This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.

The Management of Chemical Process Development in the Pharmaceutical Industry

Derek Walker
The Management of Chemical Process Development in the Pharmaceutical Industry Book PDF

Author : Derek Walker
Publisher : John Wiley & Sons
Page : 424 pages
File Size : 47,8 Mb
Release : 2008-03-03
Category : Medical
ISBN : 9780470259504

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The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker Pdf

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.

The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries

T Cochrane
The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries Book PDF

Author : T Cochrane
Publisher : Elsevier
Page : 0 pages
File Size : 40,9 Mb
Release : 2029-01-01
Category : Medical
ISBN : 1908818360

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The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries by T Cochrane Pdf

Innovative new technology now allows the measurement and collection of data throughout many manufacturing processes previously unavailable. The The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries is a starting point for anyone who has been tasked to use technology to measure and collect data to gain an understanding of their processes in order to improve and control lengthy, complex supply chains in the pharmaceutical industry. It is a practical guide on how to apply statistical process control (SPC) within the pharmaceutical industry. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way. This book delivers a way of viewing data that is both simple and easy to understand and relates to our understanding of the world in which we work. The first book to describe SPC in the pharmaceutical and biotechnology industries Highly practical approach Contains many case studies showing the application of SPC

Case Studies in Bayesian Methods for Biopharmaceutical CMC

Paul Faya,Tony Pourmohamad
Case Studies in Bayesian Methods for Biopharmaceutical CMC Book PDF

Author : Paul Faya,Tony Pourmohamad
Publisher : CRC Press
Page : 423 pages
File Size : 41,7 Mb
Release : 2022-12-15
Category : Mathematics
ISBN : 9781000824865

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Case Studies in Bayesian Methods for Biopharmaceutical CMC by Paul Faya,Tony Pourmohamad Pdf

The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia • Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems