Drugs and the Pharmaceutical Sciences series is designed to enable the pharmaceutical scientist to stay abreast of the changing trends, advances and innovations associated with therapeutic drugs and that area of expertise and interest that has come to be known as the pharmaceutical sciences. The body of knowledge that those working in the pharmaceutical environment have to work with, and master, has been, and continues, to expand at a rapid pace as new scientific approaches, technologies, instrumentations, clinical advances, economic factors and social needs arise and influence the discovery, development, manufacture, commercialization and clinical use of new agents and devices.
Edited
By Ira R. Berry, Robert P. Martin
June 07, 2019
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by ...
Edited
By Paul G. Pearson, Larry C. Wienkers
May 21, 2019
This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug ...
Edited
By Anthony J. Hickey, Sandro R. da Rocha
May 01, 2019
This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to ...
By Marc B. Brown, Adrian C. Williams
March 11, 2019
The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in ...
Edited
By Graham P. Bunn
February 18, 2019
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. ...
Edited
By Isaac Ghebre-Sellassie, Charles E. Martin, Feng Zhang, James DiNunzio
March 16, 2018
The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix ...
Edited
By Mariko Morishita, Kinam Park
June 16, 2017
Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science who discuss the latest advances in biodrug delivery systems and associated techniques. The book discusses ...
Edited
By Terry Jacobs, Andrew A. Signore
June 27, 2016
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on ...
By 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 ...
Edited
By Leon Shargel, Isadore Kanfer
October 24, 2013
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory ...
Edited
By Krzysztof Jozwiak, W. J. Lough, Irving W. Wainer
April 23, 2012
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology. Topics include: The use of enzymes in the synthesis and ...
Edited
By Metin Celik
August 22, 2011
Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides...