Pharmaceutical Science Books

New and Published Books

1. Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

   Edited by Anurag S. Rathore, Gail Sofer

   Series: Biotechnology and Bioprocessing

   Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as...

   Published May 8th 2012 by CRC Press
2. Quantitative Pharmacology

   An Introduction to Integrative Pharmacokinetic-Pharmacodynamic Analysis

   By Johan Gabrielsson, Stephan Hjorth

   PKPD awareness is vital if we are to attempt to relate preclinical results to the acute and long term consequences in humans. The debate on whether preclinical findings can be translated to the human usage is still engaging scientists across industry, academia and regulatory bodies....

   Published May 6th 2012 by Swedish Pharmaceutical Press
3. Safety Pharmacology in Pharmaceutical Development

   Approval and Post Marketing Surveillance, Second Edition

   By Shayne C. Gad

   This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years...

   Published April 25th 2012 by CRC Press
4. Pharmacogenomics of Alcohol and Drugs of Abuse

   Edited by Amitava Dasgupta, Loralie J. Langman

   Pharmacogenomics is the basis of personalized medicine, which is said to be the medicine of the future. The same pharmacogenomics principles that are applicable for therapeutic drugs are also applicable for drugs of abuse. Understanding genetic variation in alcohol response is vital for...

   Published April 22nd 2012 by CRC Press
5. Regenerative Medicine, Stem Cells and the Liver

   By David C. Hay

   The liver is an amazing organ which performs a myriad of functions necessary for life. The regenerative capacity of the liver is captivating and has been recognized for centuries. However, when the liver is overwhelmed by insulting stimuli or is chronically damaged, the regenerative capability of...

   Published April 11th 2012 by Science Publishers
6. Handbook of Statistics in Clinical Oncology, Third Edition

   Edited by John Crowley, Antje Hoering

   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...

   Published March 25th 2012 by Chapman and Hall/CRC
7. Basic Pharmacokinetics, Second Edition

   By Mohsen A. Hedaya

   Series: Array

   Knowledge of pharmacokinetics is critical to understanding the absorption, distribution, metabolism, and excretion of drugs. It is therefore vital to those engaged in the discovery, development, and preclinical and clinical evaluation of drugs, as well as practitioners involved in the clinical use...

   Published February 8th 2012 by CRC Press
8. Randomized Clinical Trials of Nonpharmacological Treatments

   Edited by Isabelle Boutron, Philippe Ravaud, David Moher

   Series: Chapman & Hall/CRC Biostatistics Series

   Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval....

   Published December 18th 2011 by Chapman and Hall/CRC
9. Disposable Bioprocessing Systems

   By Sarfaraz K. Niazi

   Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the...

   Published December 18th 2011 by CRC Press
10. Fermentation Microbiology and Biotechnology, Third Edition

    Edited by E. M. T. El-Mansi, C. F. A. Bryce, Arnold L. Demain, A.R. Allman

    Fermentation Microbiology and Biotechnology, Third Edition explores and illustrates the diverse array of metabolic pathways employed for the production of primary and secondary metabolites as well as biopharmaceuticals. This updated and expanded edition addresses the whole spectrum of fermentation...

    Published December 11th 2011 by CRC Press