Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition


  • Leon Sharge, Applied Biopharmaceutics, Raleigh, North Carolina, USA
  • Isadore Kanfer, Rhodes University, Grahamstown, South Africa


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.

New to This Edition

  • 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.
  • Textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Key Features

  • Describes from concept to market approval, the development of high-quality, safe, and efficacious solid oral generic drug products
  • Discusses the scientific, regulatory, and legal considerations for the development of generic drug products
  • Outlines a variety of patent challenges presented by the brand-name pharmaceutical industry
  • Examines scale-up, post-approval changes, and post-marketing surveillance
  • Details the ANDA regulatory approval process

Book details

  • Publisher: CRC Press; 2 edition (October 24, 2013)
  • Language: English



This content is for gold members only. Log In or Register to see
Tags: , , , , , , ,

Comments are closed.