{"product_id":"9781420086355","title":"Generic Drug Product Development Solid Oral Dosage Forms, Second Edition","description":"\u003ch3\u003eDrugs and the Pharmaceutical Sciences\u003c\/h3\u003e\u003ch1\u003eGeneric Drug Product Development\u003c\/h1\u003e\u003ch2\u003eSolid Oral Dosage Forms, Second Edition\u003c\/h2\u003e\u003ch3\u003eLeon Shargel | Isadore Kanfer\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eMedical \/ Pharmacy\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\n\u003cp\u003eIn 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 concerns.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eGeneric Drug Product Development: Solid Oral Dosage Forms, Second Edition\u003c\/b\u003e presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.\u003cbr\u003e\u003cbr\u003eMajor topics discussed include:\u003c\/p\u003e\n\u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eActive pharmaceutical ingredients\u003c\/li\u003e \u003cli\u003eExperimental formulation development, including a new section on Quality by Design (QbD)\u003c\/li\u003e \u003cli\u003eScale-up\u003c\/li\u003e \u003cli\u003eCommercial product formulation\u003c\/li\u003e \u003cli\u003eQuality control and bioequivalence\u003c\/li\u003e \u003cli\u003eDrug product performance\u003c\/li\u003e \u003cli\u003eANDA regulatory process\u003c\/li\u003e \u003cli\u003ePost-approval changes\u003c\/li\u003e \u003cli\u003ePost-marketing surveillance\u003c\/li\u003e \u003cli\u003eLegislative and patent challenges \u003c\/li\u003e \u003c\/ul\u003e\n\u003cp\u003eThis second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.\u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e\n\u003cp\u003e\u003cstrong\u003eLeon Shargel, PhD\u003c\/strong\u003e is the manager and founder of Applied Biopharmaceutics, LLC, a pharmaceutical consulting firm. Dr. Shargel is also an Affiliate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore. He has wide experience in industry and academia and has more than 200 publications, including several leading textbooks in pharmaceutical education and the generic pharmaceutical industry. Dr. Shargel received his Ph.D. in pharmacology from the George Washington University, Medical Center, Washington, D.C., and his B.S. in pharmacy from the University of Maryland, Baltimore, MD.\u003c\/p\u003e\n\u003cp\u003eIsadore Kanfer, PhD is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999–2007), Rhodes University, Grahamstown, South Africa. Dr. Kanfer has been a visiting professor at the University of California-San Francisco and the University of North Carolina School of Pharmacy, Chapel Hill. He spent several years in the pharmaceutical industry in Canada and has written or contributed to several book chapters and more than 200 research publications and conference presentations. Dr. Kanfer received his B.Sc. in pharmacy and Ph.D. in pharmaceutics from Rhodes University, Grahamstown, South Africa. \u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e24 October 2013\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eCRC Press\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eCRC Press\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9781420086355\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePage Count: \u003c\/td\u003e\n\u003ctd\u003e397\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e24.88\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"CRC Press","offers":[{"title":"Default Title","offer_id":63541183086732,"sku":"9781420086355","price":279.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/lateknightbooks.com\/products\/9781420086355","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}