Statistical Design And Analysis Of Stability Studies

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Statistical Design and Analysis of Stability Studies

Shein-Chung Chow
Statistical Design and Analysis of Stability Studies Book PDF

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 352 pages
File Size : 50,5 Mb
Release : 2007-05-30
Category : Mathematics
ISBN : 1584889063

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Statistical Design and Analysis of Stability Studies by Shein-Chung Chow Pdf

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

Statistical Design and Analysis in Pharmaceutical Science

Shein-Chung Chow,Jen-pei Liu
Statistical Design and Analysis in Pharmaceutical Science Book PDF

Author : Shein-Chung Chow,Jen-pei Liu
Publisher : CRC Press
Page : 581 pages
File Size : 43,5 Mb
Release : 2018-10-03
Category : Mathematics
ISBN : 9781482273137

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Statistical Design and Analysis in Pharmaceutical Science by Shein-Chung Chow,Jen-pei Liu Pdf

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Statistical Design and Analysis in Pharmaceutical Science

Shein-Chung Chow,Jen-pei Liu
Statistical Design and Analysis in Pharmaceutical Science Book PDF

Author : Shein-Chung Chow,Jen-pei Liu
Publisher : CRC Press
Page : 580 pages
File Size : 47,7 Mb
Release : 1995-02-22
Category : Mathematics
ISBN : 0824793366

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Statistical Design and Analysis in Pharmaceutical Science by Shein-Chung Chow,Jen-pei Liu Pdf

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Statistical Design and Analysis of Clinical Trials

Weichung Joe Shih,Joseph Aisner
Statistical Design and Analysis of Clinical Trials Book PDF

Author : Weichung Joe Shih,Joseph Aisner
Publisher : CRC Press
Page : 240 pages
File Size : 44,7 Mb
Release : 2015-07-28
Category : Mathematics
ISBN : 9781482250503

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Statistical Design and Analysis of Clinical Trials by Weichung Joe Shih,Joseph Aisner Pdf

Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu

Design and Analysis of Bioavailability and Bioequivalence Studies

Shein-Chung Chow,Jen-pei Liu
Design and Analysis of Bioavailability and Bioequivalence Studies Book PDF

Author : Shein-Chung Chow,Jen-pei Liu
Publisher : CRC Press
Page : 758 pages
File Size : 45,6 Mb
Release : 2008-10-15
Category : Mathematics
ISBN : 9781420011678

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Design and Analysis of Bioavailability and Bioequivalence Studies by Shein-Chung Chow,Jen-pei Liu Pdf

Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Shein-Chung Chow
Encyclopedia of Biopharmaceutical Statistics Four Volume Set Book PDF

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 4057 pages
File Size : 45,9 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9781351110259

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by Shein-Chung Chow Pdf

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.

Design and Analysis of Clinical Trials with Time-to-Event Endpoints

Karl E. Peace
Design and Analysis of Clinical Trials with Time to Event Endpoints Book PDF

Author : Karl E. Peace
Publisher : CRC Press
Page : 616 pages
File Size : 41,5 Mb
Release : 2009-04-23
Category : Mathematics
ISBN : 9781420066401

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Design and Analysis of Clinical Trials with Time-to-Event Endpoints by Karl E. Peace Pdf

Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "noninformativeness" of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. After reviewing time-to-event endpoint methodology, clinical trial issues, and the design and monitoring of clinical trials, the book focuses on inferential analysis methods, including parametric, semiparametric, categorical, and Bayesian methods; an alternative to the Cox model for small samples; and estimation and testing for change in hazard. It then presents descriptive and graphical methods useful in the analysis of time-to-event endpoints. The next several chapters explore a variety of clinical trials, from analgesic, antibiotic, and antiviral trials to cardiovascular and cancer prevention, prostate cancer, astrocytoma brain tumor, and chronic myelogonous leukemia trials. The book then covers areas of drug development, medical practice, and safety assessment. It concludes with the design and analysis of clinical trials of animals required by the FDA for new drug applications. Drawing on the expert contributors’ experiences working in biomedical research and clinical drug development, this comprehensive resource covers an array of time-to-event methods and explores an assortment of real-world applications.

Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement

Iftekhar Khan
Design Analysis of Clinical Trials for Economic Evaluation Reimbursement Book PDF

Author : Iftekhar Khan
Publisher : CRC Press
Page : 339 pages
File Size : 51,8 Mb
Release : 2015-11-11
Category : Mathematics
ISBN : 9781466505483

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Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement by Iftekhar Khan Pdf

Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing

Controversial Statistical Issues in Clinical Trials

Shein-Chung Chow
Controversial Statistical Issues in Clinical Trials Book PDF

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 611 pages
File Size : 40,5 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 9781439849620

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Controversial Statistical Issues in Clinical Trials by Shein-Chung Chow Pdf

In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development (such as bioavailability/bioequivalence), bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems. Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia.

Design and Analysis of Clinical Trials for Predictive Medicine

Shigeyuki Matsui,Marc Buyse,Richard Simon
Design and Analysis of Clinical Trials for Predictive Medicine Book PDF

Author : Shigeyuki Matsui,Marc Buyse,Richard Simon
Publisher : CRC Press
Page : 400 pages
File Size : 48,9 Mb
Release : 2015-03-19
Category : Mathematics
ISBN : 9781466558168

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Design and Analysis of Clinical Trials for Predictive Medicine by Shigeyuki Matsui,Marc Buyse,Richard Simon Pdf

Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics—from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials. The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving. This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.

Quantitative Methods for Traditional Chinese Medicine Development

Shein-Chung Chow
Quantitative Methods for Traditional Chinese Medicine Development Book PDF

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 430 pages
File Size : 41,7 Mb
Release : 2015-12-01
Category : Health & Fitness
ISBN : 9781498766883

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Quantitative Methods for Traditional Chinese Medicine Development by Shein-Chung Chow Pdf

A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world’s most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency. It also contains an entire chapter of case studies and addresses critical issues in TCM development and FAQs from a regulatory perspective.

Methodologies in Biosimilar Product Development

Sang Joon Lee,Shein-Chung Chow
Methodologies in Biosimilar Product Development Book PDF

Author : Sang Joon Lee,Shein-Chung Chow
Publisher : CRC Press
Page : 329 pages
File Size : 55,9 Mb
Release : 2021-09-30
Category : Mathematics
ISBN : 9781000451948

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Methodologies in Biosimilar Product Development by Sang Joon Lee,Shein-Chung Chow Pdf

Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval. Key Features: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

Statistics In the Pharmaceutical Industry, 3rd Edition

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

Author : C. Ralph Buncher,Jia-Yeong Tsay
Publisher : CRC Press
Page : 512 pages
File Size : 49,6 Mb
Release : 2005-09-28
Category : Mathematics
ISBN : 0824754697

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

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Multiple Testing Problems in Pharmaceutical Statistics

Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz
Multiple Testing Problems in Pharmaceutical Statistics Book PDF

Author : Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz
Publisher : CRC Press
Page : 323 pages
File Size : 42,7 Mb
Release : 2009-12-08
Category : Mathematics
ISBN : 9781584889854

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Multiple Testing Problems in Pharmaceutical Statistics by Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz Pdf

Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c

Monte Carlo Simulation for the Pharmaceutical Industry

Mark Chang
Monte Carlo Simulation for the Pharmaceutical Industry Book PDF

Author : Mark Chang
Publisher : CRC Press
Page : 564 pages
File Size : 55,5 Mb
Release : 2010-09-29
Category : Mathematics
ISBN : 1439835934

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Monte Carlo Simulation for the Pharmaceutical Industry by Mark Chang Pdf

Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies. The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference. This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.