Pharmaceutical Science

Clinical Trials

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

4th Edition

Shein-Chung Chow
August 13, 2018

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...

Analytical Similarity Assessment in Biosimilar Product Development

1st Edition

Shein-Chung Chow
August 01, 2018

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of...

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R

1st Edition

Jianrong Wu
June 18, 2018

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with...

Handbook of Statistics in Clinical Oncology

3rd Edition

John Crowley, Antje Hoering
September 12, 2017

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been...

Sample Size Calculations in Clinical Research

3rd Edition

Shein-Chung Chow, Jun Shao, Hansheng Wang, Yuliya Lokhnygina
August 30, 2017

Praise for the Second Edition: "… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size...

CRC Handbook of Sample Size Guidelines for Clinical Trials

1st Edition

Jonathan J. Shuster
July 27, 2017

The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size...

Cluster Randomised Trials

2nd Edition

Richard J. Hayes, Lawrence H. Moulton
June 27, 2017

Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against...

Clinical Trial Optimization Using R

1st Edition

Alex Dmitrienko, Erik Pulkstenis
June 07, 2017

Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as...

A Practical Guide to Managing Clinical Trials

1st Edition

JoAnn Pfeiffer, Cris Wells
May 19, 2017

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site...

Clinical Trial Data Analysis Using R and SAS

2nd Edition

Ding-Geng (Din) Chen, Karl E. Peace, Pinggao Zhang
May 03, 2017

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it …The...

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials

1st Edition

Toshiro Tango
February 16, 2017

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The...

Bioequivalence and Statistics in Clinical Pharmacology

2nd Edition

Scott D. Patterson, Byron Jones
December 20, 2016

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and...

Conferences

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