The 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.
Filtration and Purification in the Biopharmaceutical Industry, Third Edition
Pharmaceutical Extrusion Technology
Biosimilar Drug Product Development
Maik W. Jornitz
June 14, 2019
The third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of this field...
Paul G. Pearson, Larry C. Wienkers
May 27, 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...
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...
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...
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....
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...
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...
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...
Linda A. Felton
October 13, 2016
Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many...
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...
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...
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...