Generic Drug Product Development
Solid Oral Dosage Forms
1st Edition
Published on 1. December 2004
Book
Hardback
408 pages
978-0-8247-5460-0 (ISBN)
Description
Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
More details
Series
Language
English
Place of publication
New York
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Pharmacists; pharmacologists; clinical investigators; pharmaceutical industry professionals involved in clinical, regulatory, statistical, and legal development of generic drugs; and graduate and upper-level undergraduate students who intend to pursue careers in the pharmaceutical industry
Illustrations
5 s/w Photographien bzw. Rasterbilder
5 Halftones, black and white
Dimensions
Height: 229 mm
Width: 152 mm
Weight
658 gr
ISBN-13
978-0-8247-5460-0 (9780824754600)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Leon Shargel | Isadore Kanfer
Generic Drug Product Development
Solid Oral Dosage Forms, Second Edition
Book
10/2013
2nd Edition
CRC Press
€302.50
Shipment within 15-20 days
Additional editions
E-Book
10/2014
CRC Press
€53.99
Available for download
Person
Content
Introduction to Generic Drug Development Leon Shargel and Izzy Kanfer; Active Pharmaceutical Ingredients Edward Cohen and Lih-Yang Lin; Analytical Methods Development and Validation Nicholas Cappuccino; Experimental Formulation Development Izzy Kanfer, Peter H.R. Persicaner, and Roderick B. Walker; Scale-up, Technology Transfer and Validation Salah U. Ahmed, Venkatesh Naini, and Dilip Wadgaonker; Product Stability Pranab K. Bhattacharyya; Quality Control and Quality Assurance Loren Gelber and Joan Janulis; Drug Product Performance, In Vitro Pradeep Sathe, Larry Ouderkirk, Ajaz Hussain, and Lawrence X.Yu; ANDA Regulatory Approval Process Timothy W. Ames, Karen A. Bernard, Beth Fabian Fritsch, Koung Lee, Aida L. Sanchez, Krista M. Scardina, and Martin Shimer; Bioequivalence and Drug Product.