"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "
"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research ...
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds.
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for ea...
This work details the statistical inference of linear models including parameter estimation, hypothesis testing, confidence intervals, and prediction. The authors discuss the application of statistical theories and methodologies to various linear models such as the linear regression model, the analysis of variance model, the analysis of covariance model, and the variance components model.
This work details the statistical inference of linear models including parameter estimation, hypothesis testing, confidence intervals, and prediction....
Offers a 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.
Offers a unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development, emphasizing biopharmaceutic...
Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies...
Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds...
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...
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 d...
Taking 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 bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.
New to the Third Edition
Four new chapters that present a thorough account...
Preeminent Experts Update a Well-Respected Book
Taking into account the regulatory and scientific developments that have occurred s...
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...
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good ...
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.
New to the Second...
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA s recent draft guidance, a new edition...
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.
Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the...
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to...
