Generic drug product development : solid oral dosage forms /: solid oral dosage forms. (2014)

• Record Type: Book
• Further Information: Note: Editors, Leon Shargel, Isadore Kanfer.
• Other Names: Shargel, Leon, 1941-; Kanfer, Isadore
• Contents: Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer [and others] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed [and others] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.
• Publisher Details: Boca Raton, FL : CRC Press/Taylor & Francis Group
• Publication Date: 2014
• Extent: 1 online resource (pages)
• Subjects: 615/.19; Generic drugs; Solid dosage forms; Drugs, Generic -- standards; Chemistry, Pharmaceutical -- standards; Drug Approval; Tablets; MEDICAL -- Pharmacology; Generic drugs; Solid dosage forms; Electronic books
• Languages: English
• ISBNs: 9781420086362; 1420086367
• Related ISBNs: 9781420086355; 1420086359
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.