The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
"synopsis" may belong to another edition of this title.
LEON SHARGEL is Manager, Applied Biopharmaceutics, LLC, Raleigh, North Carolina, USA. Dr. Shargel is also Affiliate Associate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA. He received his B.S. in Pharmacy from the University of Maryland, Baltimore, MD and his Ph.D. in Pharmacology from the George Washington University Medical Center, Washington D.C., USA. Dr. Shargel is a registered pharmacist and has written over 150 papers, chapters and several major textbooks within the subject of pharmaceutical science. He is also co-editor of Informa Healthcare’s Generic Drug Product Development: Bioequivalence Issues, Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product Development: Specialty Drug Products. Dr. Shargel currently serves on the USP Biopharmaceutics Expert Committee and is actively involved in teaching and consulting activities.
ISADORE KANFER is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999-2007), Rhodes University, Grahamstown, South Africa. He has been a visiting professor at the University of California, San Francisco, California, and the University of North Carolina School of Pharmacy, Chapel Hill, North Carolina, USA. Dr. Kanfer also spent several years in the pharmaceutical industry in Canada. He received his BSc(Pharmacy) degree and Ph.D. in Pharmaceutics from Rhodes University, Grahamstown, South Africa. Having written or contributed to several book chapters and more than 200 research publications and conference presentations, Dr. Kanfer is Co-Editor of Informa Healthcare’s Generic Drug Product Development: Bioequivalence Issues, Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product Development: Specialty Drug Products. He was awarded Honorary Life membership of the South African Academy of Pharmaceutical Sciences and is Associate Editor of the Journal of Pharmacy & Pharmaceutical Sciences and a member of the editorial board of the Journal of Pharmaceutical & Biomedical Analysis. Dr. Kanfer was the recipient of the 2007 Rhodes University Vice Chancellor’s Distinguished Senior Research Award.
"This is a must for pharmaceutical researchers who are involved in developing generic specialty products with proven bioequivalence."
―Doody's Book Review Service
"About this title" may belong to another edition of this title.
Shipping:
US$ 19.97
From United Kingdom to U.S.A.
Shipping:
US$ 8.65
From United Kingdom to U.S.A.
Seller: Majestic Books, Hounslow, United Kingdom
Condition: New. pp. 288 Illus. This item is printed on demand. Seller Inventory # 7371429
Quantity: 1 available
Seller: Books Unplugged, Amherst, NY, U.S.A.
Condition: New. Buy with confidence! Book is in new, never-used condition 1.15. Seller Inventory # bk0849377846xvz189zvxnew
Quantity: 1 available
Seller: UK BOOKS STORE, London, LONDO, United Kingdom
Condition: New. Brand New! Fast Delivery This is an International Edition and ship within 24-48 hours. Deliver by FedEx and Dhl, & Aramex, UPS, & USPS and we do accept APO and PO BOX Addresses. Order can be delivered worldwide within 7-12 days and we do have flat rate for up to 2LB. Extra shipping charges will be requested if the Book weight is more than 5 LB. This Item May be shipped from India, United states & United Kingdom. Depending on your location and availability. Seller Inventory # CB 9780849377846
Quantity: Over 20 available
Seller: Universal Store, Princeton Junction, NJ, U.S.A.
Condition: New. Brand New! . "This is an International Edition." Book is In New condition and ship within One Working Day Tracking Number Provided by Customer 12-24 In To Hour, Deliver by FedEx & Aramex, UPS, & USPS Act. Order can be delivered worldwide With In 8-14 Working day Delivery. Ship from India & United States. Seller Inventory # CBS38286
Quantity: Over 20 available
Seller: GreatBookPrices, Columbia, MD, U.S.A.
Condition: New. Seller Inventory # 5117727-n
Quantity: 1 available
Seller: PBShop.store US, Wood Dale, IL, U.S.A.
HRD. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # FT-9780849377846
Quantity: 1 available
Seller: PBShop.store UK, Fairford, GLOS, United Kingdom
HRD. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # FT-9780849377846
Quantity: 1 available
Seller: GreatBookPricesUK, Castle Donington, DERBY, United Kingdom
Condition: New. Seller Inventory # 5117727-n
Quantity: 1 available
Seller: GreatBookPricesUK, Castle Donington, DERBY, United Kingdom
Condition: As New. Unread book in perfect condition. Seller Inventory # 5117727
Quantity: 1 available
Seller: Mispah books, Redhill, SURRE, United Kingdom
Hardcover. Condition: Like New. Like New. book. Seller Inventory # ERICA75808493778466
Quantity: 1 available