GENERIC DRUGS: Guidelines for bioequivalence studies - Softcover

Vishwakarma, Pushpendra Kumar

Softcover

ISBN 10: 3639343778 ISBN 13: 9783639343779

Publisher: VDM Verlag Dr. Müller, 2011

Synopsis

A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies.

About this title

About the Author

Pushpendra kr. Vishwakarma have done B.pharma from Oriental College of Pharmacy, India.

Edition details

• Publisher: VDM Verlag Dr. Müller
• Publication date: 2011
• Language: English
• ISBN 10: 3639343778
• ISBN 13: 9783639343779
• Binding: Paperback
• Number of pages: 148