{"id":22705,"date":"2018-08-08T13:29:02","date_gmt":"2018-08-08T11:29:02","guid":{"rendered":"https:\/\/kymos.com\/news\/bioequivalencia-de-productes-generics-topics\/"},"modified":"2025-08-07T09:37:53","modified_gmt":"2025-08-07T07:37:53","slug":"bioequivalencia-de-productes-generics-topics","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/bioequivalencia-de-productes-generics-topics\/","title":{"rendered":"Bioequival\u00e8ncia de productes gen\u00e8rics t\u00f2pics"},"content":{"rendered":"

El setembre de 2018, la FDA va revisar l’estat dels productes gen\u00e8rics t\u00f2pics i les seves perspectives de futur en una confer\u00e8ncia de dos dies sobre el taller<\/a> de desenvolupament de productes farmac\u00e8utics gen\u00e8rics complexos.<\/span><\/p>\n

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Un any abans, a l’octubre de 2017, la FDA va celebrar un taller previ sobre medicaments gen\u00e8rics dermatol\u00f2gics t\u00f2pics. A continuaci\u00f3, trobareu les principals idees discutides durant la confer\u00e8ncia sobre la prova de rendiment in vitro<\/i> amb c\u00e8l\u00b7lules de Franz. <\/span><\/p>\n

Qu\u00e8 hi ha a la refer\u00e8ncia que s’ha de duplicar en el gen\u00e8ric perqu\u00e8 sigui realment equivalent?<\/span><\/span><\/h4>\n

The only difference between the generic and the brand product should be the price<\/strong>; then, the generic must demonstrate to be bioequivalent to the reference. Bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient become available at the site of action.<\/span><\/p>\n

What do regulators look at in Generic products?<\/span><\/h2>\n

Regulators look at 2 things: Bioequivalence<\/b> (to show the performance and the physiologic system will be the same as the reference); and Pharmaceutical equivalence<\/b> (the same safety and efficacy profile). The substitutability of a generic is based on the similarity, the criterion is the demonstration of a shared identity with the referenced product.<\/span><\/p>\n

Bioequivalence may be demonstrated via Clinical endpoint study; however, it is not sensitive and it requires many subjects. For topical products is difficult to measure Pharmacokinetics. Systemic decay (pharmacokinetics) doesn\u2019t always represent the site of action. <\/span><\/p>\n

Even if there is a significant systemic absorption there is no assurance that the pharmacokinetics are relevant to the therapeutic effect at the topical site, because of product complexity. Formulations having the same qualitative composition may result in different functioning product.<\/span><\/p>\n

Is there any alternative approach?<\/span><\/h2>\n

New technologies are available to provide valid approaches for topical generic product equivalents.<\/span><\/p>\n