(redirected from Therapeutic Equivalence)
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References in periodicals archive ?
17) Therapeutic equivalence for a generic molecule is established if it demonstrates bioequivalence to its reference drug.
In suggesting the use of "EQ," health authorities argued that this would increase consumer options among products with proven therapeutic equivalence, thereby reducing price.
max] between products is actually safe--that is, which ranges of bioequivalence translate to therapeutic equivalence and which do not.
When used for psychiatric disorders, the margin of safety is unknown and switching may be appropriate Chlorpromazine Generic formulations are not bioequivaient Clozapine Generic formulations may not be bioequivaient at all dosages * Dosage adjustments may be needed in patients who need to switch formulations during treatment Venlafaxine Some formulations may not be interchangeable * * Consult the FDA's Approved drug pre interchangeable ducts with therapeutic equivalence evaluations to determine if generics are interchangeable Source: Reference 4
In contrast to classic MAO inhibitors, moclobemide has not clearly demonstrated therapeutic equivalence to tincyclic antidepressants or to older MAO inhibitors.
They systematically request other Member States to verify the information provided by the applicant and to give information on its therapeutic equivalence.
The first issue included in-depth information on seven new generics, new data on the treatment of hypertension, four pharmaceutical company profiles, and information on therapeutic equivalence.
assigned SangCya with an "AB" rating) in its publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the "Orange Book").
The data source for Supplement T' items covering the December 1992-April 1995 period was Food and Drug Administration, Center for Drug Evaluation and Research, Approved Drug Products with Therapeutic Equivalence Evaluations, 15th ed.
On January 16, 2018, the Office of Generic Drugs received the first substantially complete generic drug application that contained a paragraph IV certification, which is defined as a certification that a patent submitted to FDA by the brand-name drug's sponsor and listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations is, in the generic applicant's opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product.
Following issue, VIMOVO is expected to be listed in the US FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, concluded the company.
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