Cantitate/Preț
Produs
Total produse
Vezi coșul
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition de Leon Shargel

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: Drugs and the Pharmaceutical Sciences

Editat de Leon Shargel, Isadore Kanfer
en Limba Engleză Hardback – 24 oct 2013
In this era of increased pharmaceutical industry competition, 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.

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.

Major topics discussed include:
  • Active pharmaceutical ingredients
  • Experimental formulation development, including a new section on Quality by Design (QbD)
  • Scale-up
  • Commercial product formulation
  • Quality control and bioequivalence
  • Drug product performance
  • ANDA regulatory process
  • Post-approval changes
  • Post-marketing surveillance
  • Legislative and patent challenges
This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (3) 31662 lei  6-8 săpt.
  CRC Press – 14 oct 2024 31662 lei  6-8 săpt.
  CRC Press – 5 sep 2019 36814 lei  6-8 săpt.
  CRC Press – 15 oct 2019 36973 lei  6-8 săpt.
Hardback (3) 95593 lei  6-8 săpt.
  CRC Press – 25 mar 2010 95593 lei  6-8 săpt.
  CRC Press – 25 mar 2010 98243 lei  6-8 săpt.
  CRC Press – 24 oct 2013 112411 lei  6-8 săpt.

Din seria Drugs and the Pharmaceutical Sciences

Preț: 112411 lei

Preț vechi: 151989 lei
-26% Nou

Puncte Express: 1686
Preț estimativ în valută:
21513€ • 22630$ • 17950£

Carte tipărită la comandă

Livrare economică 09-23 ianuarie 25

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9781420086355
ISBN-10: 1420086359
Pagini: 397
Ilustrații: 36 b/w images and 47 tables
Dimensiuni: 156 x 234 x 23 mm
Greutate: 0.71 kg
Ediția:Revizuită
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

Cuprins

Generic Drug Product Development and Therapeutic Equivalence. Active Pharmaceutical Ingredients.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.

Notă biografică

Leon Shargel, PhD is the manager and founder of Applied Biopharmaceutics, LLC, a pharmaceutical consulting firm. Dr. Shargel is also an Affiliate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore. He has wide experience in industry and academia and has more than 200 publications, including several leading textbooks in pharmaceutical education and the generic pharmaceutical industry. Dr. Shargel received his Ph.D. in pharmacology from the George Washington University, Medical Center, Washington, D.C., and his B.S. in pharmacy from the University of Maryland, Baltimore, MD.
Isadore Kanfer, PhD is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999–2007), Rhodes University, Grahamstown, South Africa. Dr. Kanfer has been a visiting professor at the University of California-San Francisco and the University of North Carolina School of Pharmacy, Chapel Hill. He spent several years in the pharmaceutical industry in Canada and has written or contributed to several book chapters and more than 200 research publications and conference presentations. Dr. Kanfer received his B.Sc. in pharmacy and Ph.D. in pharmaceutics from Rhodes University, Grahamstown, South Africa.

Recenzii

"Written by experts from academia, industries, and regulatory agency, this is an update of a comprehensive review of the generic oral solid drug product development process. It presents various aspects of generic drug product development with formulation development through to post-approval changes. This edition includes a new chapter on the U.S. Pharmacopeial Convention and its role in harmonization. ... This book will be a standard reference for everyone working on or studying generic drug product development, in industry, academia, and regulatory agency."
—Rahmat M. Talukder, PhD, RPh, West Coast University School of Pharmacy, in Doody's Book Reviews"This text would be most useful for industry and regulatory professionals, but it would also provide a good reference text for pharmacy students wanting to become familiar with the considerations of generic drug development."
—Emma McConnell, Medical Writer

Descriere

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.