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Generic Substitution: Issues for Problematic Drugs: Discussion
In 1986, the FDA adopted the currently used decision rule, which tests the more . "A generic product that truly differs by -20%/+25% or more from the innovator .
http://www.medscape.com/viewarticle/410695_7

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The generics in transplantation and the rules on their use.
The generics in transplantation and the rules on their use. . Currently there are 5 FDA approved Cyclosporine generics with a 20% market share in the USA and .
http://www.ncbi.nlm.nih.gov/pubmed/15859910

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Generic versus Brand Name drugs - which are better?
What the FDA requires is that any approved generic version of a name brand drug is effective within a 20% range. What this means is that the generic drug can .
http://kentent.hubpages.com/hub/Generic-versus-Brand-Name-drugs---which-are-better

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Bioequivalence | Generic Pharmaceutical Association
This simply is not true and any generic with a difference that dramatic would never be approved by the FDA. The 20% to 25% margin is one part of a complex .
http://www.gphaonline.org/issues/bioequivalence

Orange Book Preface - FDA
Feb 3, 2012 . The final rule, which includes FDA's responses to the public . The first of the two one-sided tests determines whether a generic . Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the .
http://www.fda.gov/drugs/developmentapprovalprocess/ucm079068.htm

Patents and the Possibility of Generic Biologic Drugs- Part III of a III ...
The patent life for drugs is 20 years but the Patient Protection and Affordable . to approve generic biologics to be marketed, with the FDA setting the rules as to .
http://www.therubins.com/legal/generbiol.htm

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