Normal View MARC View ISBD View

Generic drug product development : solid oral dosage forms /

Authors: Shargel, Leon,%1941- | Kanfer, Isadore. Series: Drugs and the pharmaceutical sciences ; . v. 129 Published by : CRC Press/Taylor & Francis Group, (Boca Raton, FL :) Physical details: xii, 385 p. : ill. ; 25 cm. ISBN: 1420086359 Subject(s): Generic drugs. | Solid dosage forms. | Drugs, Generic %standards. | Chemistry, Pharmaceutical %standards. | Drug Approval. | Tablets. Year: 2014
Tags from this library:
No tags from this library for this title.
Item type Location Call Number Status Date Due
Book Book AUM Main Library 615.19 G326 (Browse Shelf) Available

Includes bibliographical references and index.

Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.

"This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher.

There are no comments for this item.

Log in to your account to post a comment.