Biomedical Science


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Biomarker Analysis in Clinical Trials with R

1st Edition

Nusrat Rabbee
April 01, 2020

The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into...

Bayesian inference with INLA

1st Edition

Virgilio Gomez-Rubio
February 17, 2020

The integrated nested Laplace approximation (INLA) is a recent computational method that can fit Bayesian models in a fraction of the time required by typical Markov chain Monte Carlo (MCMC) methods. INLA focuses on marginal inference on the model parameters of latent Gaussian Markov random fields...

Estimands, Estimators and Sensitivity Analysis in Clinical Trials

1st Edition

Craig Mallinckrodt, Geert Molenberghs, Ilya Lipkovich, Bohdana Ratitch
February 10, 2020

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using...

Research Methods for Medical Graduates

1st Edition

Abhaya Indrayan
November 01, 2019

This book discusses the why and how of each step of data-based medical research that can provide basic information to emerging researchers and medical graduate students who write theses or publish articles. The chapters are arranged in the sequence of steps for data-based research. The research...

Elementary Bayesian Biostatistics

1st Edition

Lemuel A. Moyé
October 18, 2019

Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power. Presenting an introductory perspective to modern Bayesian...

Bayesian Applications in Pharmaceutical Development

1st Edition

Mani Lakshminarayanan, Fanni Natanegara
October 11, 2019

The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analyses such as the Bayesian approach are essential to...

Clinical Data Quality Checks for CDISC Compliance Using SAS

1st Edition

Sunil Gupta
October 07, 2019

Clinical Data Quality Checks for CDISC Compliance using SAS is the first book focused on identifying and correcting data quality and CDISC compliance issues with real-world innovative SAS programming techniques such as Proc SQL, metadata and macro programming. Learn to master Proc SQL’s subqueries...

Drug Interaction & Lethality Analysis

1st Edition

Marshall N. Brunden, Thomas J. Vidmar, Joseph W. McKean
August 27, 2019

First Published in 1988, Drug Interaction and Lethality Analysis offers a well-structured insight into the relationship between the chemicals we use in everyday life and the environment. With an abundance of references and detailed statistics, this book is highly recommended for students...

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

1st Edition

John O'Quigley, Alexia Iasonos, Björn Bornkamp
August 08, 2019

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of...

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach

1st Edition

Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce
July 16, 2019

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’...

Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies

1st Edition

Harry Yang, Steven Novick
July 11, 2019

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...

Textbook of Clinical Trials in Oncology: A Statistical Perspective

1st Edition

Susan Halabi, Stefan Michiels
May 16, 2019

There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for...