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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
Generic Versus Brand-Name Drugs
Instead, a generic manufacturer must prove to the FDA that it has formulated the product . This allowable difference is called the "plus-or-minus 20 percent rule.
http://www.healthguidance.org/entry/9896/1/Generic-Versus-Brand-Name-Drugs.html

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CE Online: Pharmacist's Letter
Patent protection prevents any generic version of a drug 20 years after a new drug . -20% to +25% rule.20,25 In addition, FDA states that generic products that .
http://pharmacistsletter.therapeuticresearch.com/ce/ceCourse.aspx?pc=06-36
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Bioequivalence: An overview of statistical concepts
proved generic dosage form to be marketed and accepted as therapeutically . As recommended by the US FDA (1992),1 in most bioequivalence trials, a . and µR (the 80/20 rule), where 20% was apparently arbitrarily chosen to represent .
http://medind.nic.in/ibi/t04/i4/ibit04i4p209.pdf
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PHARMCATALYST Generics Page - Info, Connections, FAST!
FDA Office of Generic Drugs . The use of the -20%/+25% rule is based on a medical decision that, for most drugs, a -20%/+25% difference in the concentration .
http://www.pharmcatalyst.com/drugsherbs/genericspub.pharm
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Generic drug - Wikipedia, the free encyclopedia
According to the U.S. Food and Drug Administration (FDA), generic drugs are . In the US, drug patents give 20 years of protection, but they are applied for before . The justices in a 5-4 ruling said generic drug companies do not share the .
http://en.wikipedia.org/wiki/Generic_drug
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Where did the 80% come from?
These results truly put more shape and depth to the 80 / 20 rule. Not only does it confirm the significant frequency of informal learning, it demonstrates that .
http://www.informl.com/where-did-the-80-come-from/
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2006.07.20: Improving Access to Generic Drugs
Jul 20, 2006 . Thursday, July 20, 2006 . In 2003, FDA published a final rule to improve access to generic drugs and lower prescription drug costs for millions .
http://www.hhs.gov/asl/testify/t060720.html

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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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Jan 16, 2012 . FDA approved pharmacy. 24/7 online support. cialis now, viagra pills without prescription, cialis 20, online propecia prescriptions buy generic .
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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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