Generic Drug Product Development: Specialty Dosage Forms, 1st Edition (Hardback) book cover

Generic Drug Product Development

Specialty Dosage Forms, 1st Edition

By Leon Shargel, Isadore Kanfer

CRC Press

288 pages | 50 B/W Illus.

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Hardback: 9780849377860
pub: 2010-03-25
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Description

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.

The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Reviews

"This is a must for pharmaceutical researchers who are involved in developing generic specialty products with proven bioequivalence."

Doody's Book Review Service

Table of Contents

Introduction, Leon Shargel

Nonsystemically Absorbed Oral Drug Products, Marc Lefebvre

Topical Drug Products—Development, Manufacture and Regulatory Issues, Mary Beth G. Erstad and Candis Edwards

Assessment of Topical Dosage Forms Intended for Local or Regional Activity, Isadore Kanfer, Ralph Nii Okai Tettey-Amlalo, Wai Ling Au, and Betsy Hughes-Formella

Rectal Dosage Forms and Suppositories, K. Rosh Vora and Mohammed N. AliChisty

Nasal and Inhalation Drug Products, John Bell and Paul Flanders

Locally Acting Nasal and Inhalation Drug Products: Regulatory and Bioequivalence Perspective, Gur Jai Pal Singh

Transdermal Dosage Forms, Mario A. González and Gary W. Cleary

Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vivo Correlation (IVIVC) Principles, Siddhesh D. Patil and Diane J. Burgess

Biosimilar Drug Products—Manufacture and Quality, Suzanne M. Sensabaugh

Index

About the Authors

LEON SHARGEL is Manager, Applied Biopharmaceutics, LLC, Raleigh, North Carolina, USA. Dr. Shargel is also Affiliate Associate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA. He received his B.S. in Pharmacy from the University of Maryland, Baltimore, MD and his Ph.D. in Pharmacology from the George Washington University Medical Center, Washington D.C., USA. Dr. Shargel is a registered pharmacist and has written over 150 papers, chapters and several major textbooks within the subject of pharmaceutical science. He is also co-editor of Informa Healthcare’s Generic Drug Product Development: Bioequivalence Issues, Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product Development: Specialty Drug Products. Dr. Shargel currently serves on the USP Biopharmaceutics Expert Committee and is actively involved in teaching and consulting activities.

ISADORE KANFER is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999-2007), Rhodes University, Grahamstown, South Africa. He has been a visiting professor at the University of California, San Francisco, California, and the University of North Carolina School of Pharmacy, Chapel Hill, North Carolina, USA. Dr. Kanfer also spent several years in the pharmaceutical industry in Canada. He received his BSc(Pharmacy) degree and Ph.D. in Pharmaceutics from Rhodes University, Grahamstown, South Africa. Having written or contributed to several book chapters and more than 200 research publications and conference presentations, Dr. Kanfer is Co-Editor of Informa Healthcare’s Generic Drug Product Development: Bioequivalence Issues, Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product Development: Specialty Drug Products. He was awarded Honorary Life membership of the South African Academy of Pharmaceutical Sciences and is Associate Editor of the Journal of Pharmacy & Pharmaceutical Sciences and a member of the editorial board of the Journal of Pharmaceutical & Biomedical Analysis. Dr. Kanfer was the recipient of the 2007 Rhodes University Vice Chancellor’s Distinguished Senior Research Award.

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology