Generic drug product development: solid oral dosage forms
by Kanfer, Isadore Shargel, Leon
"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 Pharmaco…
Read More ↓Title Statements
- Full title :Generic drug product development : solid oral dosage forms / edited by Leon Shargel, Isadore Kanfer.
Summary
"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"--Résumé de l'éditeur.
Read More ↓Edition Statements
- Publication Date:2014
- Edition:Second edition
Publication Statements
- Publisher(s):CRC Press
- Place of Publication:Boca Raton, Florida
- Language:eng
- Publication Date:2014
Notes
Vérification effectuée sur le site web de l'éditeur concernant le numéro de volume de la collection. Le volume devrait être 212 et non 129 tel qu'indiqué sur la page de titre de la collection et sur la couverture du volume.
The Physical Object
- Description:1 ressource en ligne (xii, 358 pages) : : illustrations
Edition Identifiers
- ISBN:9781420086362, 1420086367
- oclc:ocn908087312
- LC Classification:RS55.2
Table of Contents
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 autres] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed [et autres] -- 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 develop…
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