Kanfer / Shargel Generic Drug Product Development

International Regulatory Requirements for Bioequivalence
1. Auflage 2013
ISBN: 978-1-4200-2002-1
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 332 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country.  This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Zielgruppe

Specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and engineering.

Autoren/Hrsg.

Kanfer, Isadore

Shargel, Leon

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie

Inhaltsverzeichnis

Introduction. Worldwide Market for Generic Drugs.  Patents and Intellectual Property.  International Conference on Harmonization.  International Inspections, PIC.  Pharmacopoeia Harmonization and International Standards.  WHO—Essential Drug List and Multi-source Drug Products.  Registration in US.  Registration in EU.  Registration in Japan.  Registration in Canada.  Registration in Australia.  Registration in South America (Brazil).  Registration in South Africa.  Registration in India.  Registration in Turkey.  Registration in Thailand