Generic Drug Product Development Solid Oral Dosage Forms 2nd dition by Leon Shargel ISBN 1420086359 978-1420086355

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Product details: 

ISBN 10:1420086359

ISBN 13:978-1420086355

Author:Leon Shargel

In this era of increased pharmaceutical industry competition, 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.

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products―from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.

Major topics discussed include:

• Active pharmaceutical ingredients
• Experimental formulation development, including a new section on Quality by Design (QbD)
• Scale-up
• Commercial product formulation
• Quality control and bioequivalence
• Drug product performance
• ANDA regulatory process
• Post-approval changes
• Post-marketing surveillance
• Legislative and patent challenges

This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Table of contents:

 Generic Drug Product Development and Therapeutic Equivalence

 Leon Shargel and Isadore KanferActive Pharmaceutical Ingredients

 Edward M. Cohen and Steven SutherlandAnalytical Methods Development and Methods Validation for Oral Solid Dosage  Forms;  Quanyin Gao and Dilip R. SanvordekerExperimental Formulation Development

 Isadore Kanfer, Roderick B. Walker, Raimar Löbenberg, and Nádia Araci Bou-ChacraScale-up, Technology Transfer, and Process Performance Qualification

Salah U. Ahmed, Ashok Katdare, Venkatesh Naini, and Dilip WadgaonkarDrug Stability

 Pranab K. BhattacharyyaQuality Control and Quality Assurance

 Loren GelberDrug Product Performance: In Vitro; Pradeep M. Sathe, John Duan, and Lawrence X. YuANDA Regulatory Approval Process; 

 Timothy W. Ames and Aaron SiglerBioequivalence and Drug Product Assessment: In Vivo;

 Barbara M. Davit and Dale P. ConnerStatistical Considerations for Establishing Bioequivalence; 

Charles Bon and Sanford BoltonOutsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations

 Patrick K. NoonanPostapproval Changes and Postmarketing Reporting of Adverse Drug Experiences

Lorien Armour and Leon ShargelThe United States Pharmacopeia/National Formulary

Its History, Organization, and Role in Harmonization

William Brown and Margareth R. C. MarquesLegal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing; Arthur T. Tsien

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Tags: Leon Shargel, Generic, Development