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Clinical Trial Biostatistics and Biopharmaceutical Applications

Clinical Trial Biostatistics and Biopharmaceutical Applications

Walter R. Young, Ding-Geng (Din) Chen

November 20, 2014

Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical...

Handbook of Bioequivalence Testing, Second Edition

Handbook of Bioequivalence Testing, Second Edition

Sarfaraz K. Niazi

October 29, 2014

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical...

Re-inventing Drug Development

Re-inventing Drug Development

Jeffrey S. Handen

October 28, 2014

The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection,...

Design and Analysis of Cross-Over Trials, Third Edition

Design and Analysis of Cross-Over Trials, Third Edition

Byron Jones, Michael G. Kenward

October 08, 2014

Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary...

Heterogeneous Catalysis: A Versatile Tool for the Synthesis of Bioactive Heterocycles

Heterogeneous Catalysis: A Versatile Tool for the Synthesis of Bioactive Heterocycles

K.L. Ameta, Ph.D., Andrea Penoni

September 13, 2014

For more than a century, bioactive heterocycles have formed one of the largest areas of research in organic chemistry. They are important from a biological and industrial point of view as well as to the understanding of life processes and efforts to improve the quality of life. Heterogeneous...

Pharmaceutical Industry Practices on Genotoxic Impurities

Pharmaceutical Industry Practices on Genotoxic Impurities

Heewon Lee

August 29, 2014

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by...

Rational Basis for Clinical Translation in Stroke Therapy

Rational Basis for Clinical Translation in Stroke Therapy

Giuseppe Micieli, Diana Amantea

August 27, 2014

Stroke remains one of the major causes of death and long-term disability worldwide. Currently, the only approved therapy for the acute treatment of this disease is thrombolysis, a strategy that can only be applied to a small percentage of patients due to its narrow therapeutic window. Unfortunately...

Project Management for Research and Development: Guiding Innovation for Positive R&D Outcomes

Project Management for Research and Development: Guiding Innovation for Positive R&D Outcomes

Lory Mitchell Wingate

August 05, 2014

Today’s leading organizations recognize the importance of research and development (R&D) to maintain and grow market share. If companies want to survive into the future, they must accelerate their R&D-to-market cycles or find themselves behind the competition.Project Management for Research...

Nanotechnology and Drug Delivery, Volume One: Nanoplatforms in Drug Delivery

Nanotechnology and Drug Delivery, Volume One: Nanoplatforms in Drug Delivery

José L. Arias

August 04, 2014

Pharmacotherapy is often limited by the inefficient activity and severe toxicity of drug molecules. Nanotechnology offers a revolutionary and definitive approach for the efficient delivery of drug molecules to non-healthy tissues and cells. This first volume of a series of two volumes analyzes the...

Biointeractions of Nanomaterials

Biointeractions of Nanomaterials

Vijaykumar B. Sutariya, Yashwant Pathak

July 29, 2014

An examination of the widespread application of nano materials in biology, medicine, and pharmaceuticals and the accompanying safety concerns, Bio-interactions of Nano Materials addresses the issues related to toxicity and safety of nano materials and nano systems. It covers the interactions in...

Chemical Reagents for Protein Modification, Fourth Edition

Chemical Reagents for Protein Modification, Fourth Edition

Roger L. Lundblad

July 22, 2014

The use of the chemical modification of proteins has evolved over the past 80 years, benefiting from advances in analytical, physical, and organic chemistry. Over the past 30 years, the use of chemical reagents to modify proteins has been crucial in determining the function and structure of...

Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools

Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools

Marc Lavielle

July 14, 2014

Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects ModelsMixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can...

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