Generic Drug Product Development by Leon Shargel, Isadore Kanfer - 9781420086355

CRC Press

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.\n\nGeneric 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\u2014from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.\n\nMajor topics discussed include:\n\n--Active pharmaceutical ingredients \n--Experimental formulation development, including a new section on Quality by Design (QbD) \n--Scale-up \n--Commercial product formulation \n--Quality control and bioequivalence \n--Drug product performance \n--ANDA regulatory process \n--Post-approval changes \n--Post-marketing surveillance \n--Legislative .