Pharmaceutical Science

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Introduction to Market Access for Pharmaceuticals

Mondher Toumi
January 04, 2017

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market...

Sedimentation Velocity Analytical Ultracentrifugation: Discrete Species and Size-Distributions of Macromolecules and Particles

Peter Schuck
December 22, 2016

A follow-up to the experimental and instrumental aspects described in Basic Principles of Analytical Ultracentrifugation, the volume Sedimentation Velocity Analytical Ultracentrifugation: Discrete Species and Size-Distributions of Macromolecules and Particles describes the theory and practice of...

Bioequivalence and Statistics in Clinical Pharmacology, Second 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...

Advances in Pulmonary Drug Delivery

Philip Chi Lip Kwok, Hak-Kim Chan
December 20, 2016

The respiratory tract has been used to deliver biologically active chemicals into the human body for centuries. However, the lungs are complex in their anatomy and physiology, which poses challenges to drug delivery. Inhaled formulations are generally more sophisticated than those for oral and...

Poorly Soluble Drugs: Dissolution and Drug Release

Gregory K. Webster, Robert G. Bell, J. Derek Jackson
December 16, 2016

This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with...

Data and Safety Monitoring Committees in Clinical Trials, Second Edition

Jay Herson
December 13, 2016

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young...

Analyzing Longitudinal Clinical Trial Data: A Practical Guide

Craig Mallinckrodt, Ilya Lipkovich
December 06, 2016

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provide practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice. This book, with its example-oriented approach that includes numerous SAS and R code...

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Harry Yang
December 01, 2016

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and...

Cancer Inhibitors from Chinese Natural Medicines

Jun-Ping Xu
December 01, 2016

Nature is an attractive source of therapeutic and preventive compounds, and with such chemical diversity found in millions of species of plants, over 60% of currently used anticancer agents are derived from natural sources. Cancer Inhibitors from Chinese Natural Medicines summarizes new...

The Pharmaceutical Index: 2013 Worldwide NCEs

Pharmacodia (Beijing) Co.,Ltd.
November 28, 2016

An ideal drug candidate should possess good pharmacological activity, absorption, distribution, metabolism, excretion and toxicity properties. Historically, there are around 6,000 drugs being used in humans and approximately 3,000 still in clinical use, not including herbal medicines. This...

Clean Room Technology in ART Clinics: A Practical Guide

Sandro C. Esteves, Alex C. Varghese, Kathryn C. Worrilow
November 03, 2016

Regulatory agencies worldwide have issued directives or such requirements for air quality standards in embryology laboratories. This practical guide reviews the application of clean room technology or controlled environments specifically suited for Assisted Reproductive Technology (ART) Units. Its...

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance

Orlando Lopez
October 21, 2016

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based...