Generic Drug Product Development

Solid Oral Dosage Forms, Second Edition
Herausgeber: Shargel, Leon; Kanfer, Isadore

• Gebundenes Buch

Produktbeschreibung

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. In this volume, more than 30 noted specialists describe the development of generic drug products-from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. This second edition includes discussion on the relationship between the FDA and the United States Pharmacopeia and the application of Quality by Design (QbD) during formulation development.

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Produktdetails

• Verlag: CRC Press
• 2. Auflage
• Seitenzahl: 398
• Erscheinungstermin: 24. Oktober 2013
• Englisch
• Abmessung: 240mm x 161mm x 26mm
• Gewicht: 760g
• ISBN-13: 9781420086355
• ISBN-10: 1420086359
• Artikelnr.: 23609841

Autorenporträt

Leon Shargel, PhD 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. Isadore 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.

Inhaltsangabe

Generic Drug Product Development and Therapeutic Equivalence. Active
Pharmaceutical Ingredients.
Analytical Methods Development and Methods Validation for Oral Solid Dosage
Forms. Experimental Formulation Development. Scale-up, Technology Transfer,
and Process Performance Qualification. Drug Stability. Quality Control and
Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory
Approval Process. Bioequivalence and Drug Product Assessment: In Vivo.
Statistical Considerations for Establishing Bioequivalence. Outsourcing
Bioavailability and Bioequivalence Studies to Contract Research
Organizations. Postapproval Changes and Postmarketing Reporting of Adverse
Drug Experiences. The United States Pharmacopeia/National Formulary: Its
History, Organization, and Role in Harmonization. Legal and Legislative
Hurdles to Generic Drug Development, Approval, and Marketing. Index.