farmaci equivalenti
English translation: therapeutical equivalent drugs
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| 08:06 May 17, 2007 |
| Italian to English translations [PRO] Medical - Medical: Pharmaceuticals / Comunicato stampa | |||||||
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|  Selected response from: Luisa Fiorini Italy Local time: 13:35 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +3 | therapeutical equivalent drugs |
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| 4 +1 | generic drugs |
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| Discussion entries: 1 | |
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Answers
28 mins confidence: 
peer agreement (net): +3
peer agreement (net): +3therapeutical equivalent drugs Explanation: Il farmaco equivalente, o generico, è un medicinale il cui principio attivo, cioè la sostanza che svolge azione curativa, non è più coperto da brevetto (il brevetto è scaduto). Quindi è un medicinale: • esattamente equivalente a quello da cui deriva; • contiene la stessa quantità di principio attivo e la stessa efficacia clinica del farmaco ''di marca''; • si assume alle stesse dosi, con le stesse modalità e per le stesse indicazioni terapeutiche; • è sottoposto agli stessi controlli e procedure di registrazione e vigilanza che l'Agenzia Italiana del Farmaco riserva a tutti i farmaci in commercio. Therapeutically equivalent drugs have the same pharmacokinetic and pharmacodynamic properties. They have been proven bioequivalent and the FDA believes they can be expected to have the same clinical effect and adverse-events profile. In other words, therapeutically equivalent drugs are those that generally are considered most appropriate for substitution. Two drugs are considered therapeutic equivalents if they: Are approved as safe and effective Are pharmaceutical equivalents (ie, they contain identical amounts of the same active drug ingredient, are in the same dosage form, and have the same route of administration) Meet compendial or other applicable standards of strength, quality, purity, and identity Are bioequivalent; in other words, they either Do not present a known or potential bioequivalence problem and meet an acceptable in vitro standard, or Are shown to meet an appropriate bioequivalence standard if a known problem exists or a potential problem may exist Are adequately labeled Are manufactured in compliance with Current Good Manufacturing Practice regulations[3] The concept of therapeutic equivalence applies only to drugs containing the same active ingredient(s).[3] It does not apply to 2 drugs containing different ingredients used to treat the same condition. Therapeutically equivalent drugs may differ with regard to shape, scoring, configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time, and minor aspects of labeling (eg, some specific pharmacokinetic information). When such differences are important in the care of a particular patient, the prescribing physician may require that a particular brand be dispensed as a medical necessity. I farmaci equivalenti devono avere lo stesso principio attivo ed essere bioequivalenti proprio come i therapeutical equivalent drugs http://www.uspharmacist.com/index.asp?show=article&page=8_12... Therapeutic Equivalents These are approved drug products, often made by different manufacturers, that are pharmaceutical equivalents and for which bioequivalence has been demonstrated. Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. Therapeutically equivalent prescription drugs will receive an "A" equivalence evaluation code in FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (Orange Book). This term has been applied only in the context of drugs approved under section 505 of the FD&C Act. -------------------------------------------------- Note added at 29 min (2007-05-17 08:36:28 GMT) -------------------------------------------------- P.S. Therapeutically non therapeutical. Scusa! Reference: http://www.sardegnasalute.it/index.php?xsl=316&s=9&v=9&c=301... Reference: http://www.medscape.com/viewarticle/416390_2 |
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