Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current status of regulations on bioavailability and bioequivalence, including guidelines/guidances issued by the FDA, EMEA, and WHO. This edition addresses frequently asked questions and explores sample size determination, meta-analysis, and pharmacokinetics. It also offers a basic version of PharmaSoftware Solutions, Inc.’s BABE Solution 2008, with bioequivalence assessment for in vivo bioequivalence studies.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Medicinal & Pharmaceutical Chemistry
Reference

Translational medicine has become increasingly important in pharmaceutical research development. Translational Medicine: Strategies and Statistical Methods examines the critical decisions that must be made to successfully transition from basic to clinical science. With a review of existing processes, the book presents a detailed discussion of alternative research approaches that lead to faster and more accurate decisions on data. It provides insight on biomarker development in early phase clinical trials, integrates genomic and clinical databases for the establishment of medical predictive models in various diseases, and reviews the design and analysis for translating research findings.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Drug Design & Development
Reference
Professional

Taking into account the regulatory and scientific developments that have occurred since its predecessor, this third edition presents a comprehensive summary of the ever-expanding literature and research in the field. It focuses on regulatory requirements, current scientific and practical issues, and the statistical methodology of designing and analyzing bioequivalence studies. It contains four new chapters, along with several new and updated sections. This edition includes guidelines issued by the FDA, EMEA, and WHO, addresses frequently asked questions, and explores the key topics of sample size determination, meta-analysis, and pharmacokinetics.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Reference
Professional

This book explains how the formulas and procedures for sample size calculations can be used in a variety of clinical research and development stages. It presents real-world examples from several therapeutic areas to illustrate clinical and statistical concepts, interpretations, and interactions. The book also explores emerging topics in pharmaceutical research and development, including QT/QTc studies with time-dependent replicates and the use of propensity score analysis in nonrandomized or observational studies. This edition now provides sample size calculations for three major areas of clinical research: dose response studies, microarray studies, and Bayesian approaches.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Medicinal & Pharmaceutical Chemistry
Reference
Professional

Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing, focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods. The author compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. The book examines the stability analysis of a linear mixed effects model and stability analyses with discrete responses, multiple components, and frozen drug products. It also explores dissolution testing, current issues, and recent developments in stability studies.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Medicinal & Pharmaceutical Chemistry
Reference
Professional

One of the first books on the topic, Adaptive Design Methods Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures based on accrued data of ongoing clinical trials. The book also offers a well-balanced summary of current regulatory perspectives, recently developed statistical methods, and practical guidelines for choosing an optimal design. Providing a broad range of adaptive design methods that use both analytical and simulation approaches, this resource fills the need for a unified, comprehensive, and updated book in the clinical research and development of adaptive design and analysis.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Reference
Professional

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. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.
• Chapman & Hall/CRC Biostatistics Series
Statistics for the Biological Sciences
Clinical Implementation
Reference
Professional

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.
• Chapman & Hall/CRC Biostatistics Series
Clinical Implementation
Reference
Professional

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.
• Statistics: A Series of Textbooks and Monographs
Statistics for the Biological Sciences
Analysis & Pharmaceutical Quality
Clinical Implementation
Textbook
Undergraduate

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.
• Statistics: A Series of Textbooks and Monographs
Applied Mathematics
Textbook
Undergraduate