Keeping pace with the latest technologies in the field, this book describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, bioequivalence and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
"…interesting and varied reading….well written and edited. There is a good blend of authors from academia, the pharmaceutical industry, and the FDA….…useful for those working, or having an interest in generic pharmaceutical manufacture and regulation." - International Journal of Pharmaceutics
Leon Shargel, President, Applied Biopharmaceutics, Raleigh, NC and Affiliate Associate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, and was previously Vice President, Biopharmaceutics for Sandoz, Inc. (formerly Eon Labs)
He received his B.Sc. in Pharmacy and graduated Cum Laude from the University of Maryland, Baltimore, and his Ph.D. in Pharmacology with minors in Biochemistry and Drug Metabolism from George Washington University, Medical Center, Washington D.C. Besides being a licensed pharmacist, Dr. Shargel has published several major textbooks within the subject of pharmaceutical science, and has written over 100 papers and chapters specific to the field.
Dr. Shargel serves on the USP Biopharmaceutics Expert Committee, and is actively involved in teaching and consulting activities.
Isadore Kanfer, Professor of Pharmaceutics and the Dean and Head of the Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa
He has been Visiting Professor at the University of California, San Francisco and also at the University of North Carolina, Chapel Hill and spent several years in the pharmaceutical industry in Canada. Dr. Kanfer has written several book chapters and has contributed over 100 research publications and conference presentations in the areas of biopharmaceutics, bioavailability/bioequivalence and bioanalytical analysis. Dr. Kanfer has served on the editorial advisory board of the European Journal of Pharmaceutical Sciences and currently serves on the editorial board of the Journal of Pharmaceutical and Biomedical Analysis and is an associate editor of the Journal of Pharmacy and Pharmaceutical Sciences. He is a foundation member and past Chairman of the South African Academy of Pharmaceutical Sciences, a charter member of the American Association of Pharmaceutical Scientists, and has served on the Executive Committee of the Canadian Society for Pharmaceutical Sciences. He received his B.Sc.(Pharm), B.Sc.(Honours) and Ph.D. degrees from Rhodes University, South Africa.