GENERIC DRUGS: Guidelines for bioequivalence studies - Softcover

Vishwakarma, Pushpendra Kumar

 
9783639343779: GENERIC DRUGS: Guidelines for bioequivalence studies
Softcover
ISBN 10: 3639343778 ISBN 13: 9783639343779
Verlag: VDM Verlag Dr. Müller, 2011

Inhaltsangabe

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.

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Reseña del editor

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.

Biografía del autor

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

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Verlag
VDM Verlag Dr. Müller
Erscheinungsdatum
2011
Sprache
Englisch
ISBN 10 
3639343778
ISBN 13 
9783639343779
Einband
Tapa blanda
Anzahl der Seiten
148
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Verantwortliche Person
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