Generic drug product development : solid oral dosage forms / edited by Leon Shargel and Isadore Kanfer
Material type:
TextSeries: Drugs and the Pharmaceutical SciencePublication details: Boca Raton : Taylor & Francis Group, c2014. Edition: 2nd edDescription: xii, 285 p. : ill. ; 24 cmISBN: 9781420086355Subject(s): Generic drugs | Solid dosage forms | Pharmaceutical industry | Drug development | Drugs--Law and legislation | Drugs--Testing | Pharmaceutical chemistry | Tablets (Medicine)DDC classification: 23
| Item type | Current library | Home library | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|
English Lending
|
Villa College QI Campus | Villa College Library | 23 (Browse shelf(Opens below)) | Available | 14473 |
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CONTENT
Chapter 1 Generic Drug Product Development and therapeutic Equivalence
Chapter 2 Active pharmaceutical ingredient
Chapter 3 Analytical methods development and methods validation for solid oral dosage forms
Chapter 4 Experimental formulation development ]
Chapter 5 Scale-up, technology transfer, and process performance qualification
Chapter 6 Drug stability
Chapter 7 Quality control and quality assurance
Chapter 8 Drug product performance, in vitro
Chapter 9 ANDA regulatory approval process
Chapter 10 Bioequivalence and drug product assessment, in vivo
Chapter 11 Statistical considerations for establishing bioequivalence
Chapter 12 Outsourcing bioavailability and bioequivalence studies to contract research organizations
Chapter 13 Post-approval changes and post-marketing surveillance
Chapter 14 United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization
Chapter 15 Legal and legislative hurdles to generic drug development, approval and marketing
Includes references and index
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