Pharmaceutical Science

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ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry

Itay Abuhav
March 29, 2017

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a...

Biosimilar Drug Product Development

Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
March 07, 2017

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug...

CRC World Dictionary of Palms: Common Names, Scientific Names, Eponyms, Synonyms, and Etymology (2 Volume Set)

Umberto Quattrocchi
February 22, 2017

From the Foreword Umberto Quattrocchi has brought us some amazing and useful works through the various dictionaries that he has compiled. This time it is for two very important plant families the palms and the cycads that are synthesized here in these two volumes. Each entry is fascinating not just...

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

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...

Methods in Comparative Effectiveness Research

Constantine Gatsonis, Sally C. Morton
February 07, 2017

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that...

Imaging in Photodynamic Therapy

Michael R. Hamblin, Yingying Huang
February 01, 2017

This book covers the broad field of cellular, molecular, preclinical, and clinical imaging either associated with or combined with photodynamic therapy (PDT). It showcases how this approach is used clinically for cancer, infections, and diseases characterized by unwanted tissue such as...

Drugs of Natural Origin: A Treatise of Pharmacognosy, Seventh Edition

Gunnar Samuelsson, Lars Bohlin
January 05, 2017

Drugs of Natural Origin is a unique multidisciplinary book suitable for undergraduate and graduate students and teachers in the area of natural product science, but also as a complementary book for disciplines like medicinal chemistry, biochemistry and pharmacology. The book can also serve society...

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...

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