Cover image for Generic drug product development : solid oral dosage forms
Title:
Generic drug product development : solid oral dosage forms
Author:
Shargel, Leon, 1941-
ISBN:
9780824754600
Publication Information:
New York : Marcel Dekker, c2005.
Physical Description:
xi, 381 s. : res. ; 24 cm.
Series:
Drugs and the pharmaceutical sciences ; v. 143
Series Title:
Drugs and the pharmaceutical sciences ; v. 143
Contents:
Introduction to generic drug product development / Active pharmaceutical ingredients / Analytical methods development and methods validation for solid oral dosage forms / Experimental formulation development / Scale-up, process validation, and technology transfer / 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 / Scale-up, post-approval changes, and post-marketing surveillance / Outsourcing bioavailability and bioequivalence studies to contract research organizations / Legal and legislative hurdles to generic drug development, approval, and marketing
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Book 7.2/12/402246 QV 704 D8426 2005
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