{"product_id":"9781493912513","title":"AAPS Advances in the Pharmaceutical Sciences Series","description":"\u003ch1\u003eAAPS Advances in the Pharmaceutical Sciences Series\u003c\/h1\u003e \u003ch2\u003eYu, Lawrence X.; Li, Bing V.\u003c\/h2\u003e \u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling\/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products.\u003c\/p\u003e\u003cp\u003e\u003ci\u003e\u003c\/i\u003e\u003c\/p\u003e\u003cp\u003e\u003ci\u003eFDA Bioequivalence Standards\u003c\/i\u003e is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters.\u003cb\u003e \u003c\/b\u003eThe book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e \u003ch3\u003eDetails\u003c\/h3\u003e \u003cp\u003ePublished by: Springer\u003c\/p\u003e \u003cp\u003ePublication Date: 2014-09-06\u003c\/p\u003e \u003cp\u003eFormat: Hardcover\u003c\/p\u003e \u003cp\u003eISBN-13: 9781493912513\u003c\/p\u003e \u003cp\u003eDOI: 10.1007\/978-1-4939-1252-0\u003c\/p\u003e \u003cp\u003eDimensions: 235cm x155cm\u003c\/p\u003e \u003cp\u003ePages: 465\u003c\/p\u003e ","brand":"Springer New York","offers":[{"title":"Default Title","offer_id":50149064671372,"sku":"9781493912513","price":224.1,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9781493912513.jpg?v=1779570390","url":"https:\/\/lateknightbooks.com\/products\/9781493912513","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}