Integrated Pharmaceutics: Applied Preformulation, Product Design, And Regulatory Science

In this detailed text, Al-Achi, Gupta, and Stagner (pharmaceutics, Campbell U.) explain the process of pharmaceutical product design to graduate students in pharmacy, the pharmaceutical sciences, physical pharmacy, drug formulation, design, and biomedicine, as well as industry professionals. They address preformation, including the drug solubility and stability, thermodynamics, rheological aspects of formulation, interfacial science, bioavailability, and mathematical, statistical, and design-of-experiment concepts. The second part covers various types of product design, with discussion of the anatomical and bodily functions that affect delivery, advantages and disadvantages of the product, formulation design and dosage-form-specific preformulation, excipient compatibility, process design and analytical technologies, scale-up models and practices, container closure system design, risk management, in-process and final product attribute tests, and new drug application stability assessment programs. The last section addresses regulatory aspects, including US, European, and other international regulatory guidelines; generics, biosimilars, and over-the-counter drugs; accelerated drug approval and expedited access of new therapies, post-drug approval activities; drug master files and European dossiers; commissioning and qualifications; quality systems and controls; safety, toxicology, and pharmacogenomics; and advancing public health. New regulatory guidelines, such as quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, stability protocols, and the biopharmaceutical classification system, are incorporated throughout. Annotation c2013 Book News, Inc., Portland, OR (booknews.com)

ANTOINE AL-ACHI, PhD, CT (ASCP), is Associate Professor of Pharmaceutics in the College of Pharmacy & Health Sciences at Campbell University. He is also the former head of the Formulation Development Division of Campbell's Pharmaceutical Sciences Institute (CUPSI).

MALI RAM GUPTA, PhD, is Associate Professor of Pharmaceutical Sciences and Director of Pharmaceutical Education & Research Center (PERC) in the College of Pharmacy & Health Sciences. Prior to joining the faculty at Campbell University, he spent twenty-five years in various positions at Revlon, including director of quality control and assurance.

WILLIAM CRAIG STAGNER, PhD, RPh, is Professor of Pharmaceutical Sciences and Director of Campbell University's Center for Analysis of Pharmaceutical Biomaterials. Prior to joining the faculty at Campbell, he established the Pharmaceutics Department at Glaxo Research Institute.