The Drugs and 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.
Handbook of Drug Metabolism
Novel Drug Delivery Systems
The Pharmaceutical Regulatory Process
Randall J. Mrsny, Ann Daugherty
October 10, 2019
Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide...
Paul G. Pearson, Larry C. Wienkers
October 07, 2019
This timely, expanded new edition is the definitive handbook for experienced drug metabolism and pharmaceutical scientists and those new to the field.Written by internationally renowned authors, it provides integrated, comprehensive coverage of fundamental aspects of drug metabolism and the...
Maik W. Jornitz
July 12, 2019
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, 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...
Gregory E. Hardee, J. Desmond Baggo
June 19, 2019
This up-to-the-minute Second Edition of an incomparable resource describes in detail the bases for developing dosage forms for use in animals-highlighting the data necessary to meet regulatory approval.Demonstrates the successful characterization, control, and registration of new veterinary...
June 19, 2019
A comprehensive treatment of the science, technology, and regulation of rate-controlled administration of therapeutic agents, with coverage of the basic concepts, fundamental principles, biomedical rationales, and potential applications. This revised and updated edition (first in 1982) incorporates...
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...
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...