Generic Drug Product Development (Solid Oral Dosage Forms, Second Edition)
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$310.00
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Product Details
Author:
Leon Shargel, Isadore Kanfer
Format:
Hardcover
Pages:
397
Publisher:
CRC Press (October 24, 2013)
Imprint:
CRC Press
Language:
English
Audience:
Professional and scholarly
ISBN-13:
9781420086355
Weight:
24.875oz
Dimensions:
6.125" x 9.1875"
File:
TAYLORFRANCIS-TayFran_261024042415025-20261024.xml
Folder:
TAYLORFRANCIS
List Price:
$310.00
Country of Origin:
United States
Pub Discount:
30
Series:
Drugs and the Pharmaceutical Sciences
Case Pack:
20
As low as:
$294.50
Publisher Identifier:
P-CRC
Discount Code:
H
Overview
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. In this volume, more than 30 noted specialists describe the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. This second edition includes discussion on the relationship between the FDA and the United States Pharmacopeia and the application of Quality by Design (QbD) during formulation development.
