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Merck poured out a zeal in the evaluation of the formula



The industry chooses to control a large number of patients in an attempt to mechanically mask a bioequivalence deficit in both versions of the drug.

By Pascale Santi et Stéphane Foucart Public aujourd'hui at 04h40, mis at jour at 10h51

Temps de Lecture 5 min.

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Check out the process at the Merck Laboratory in Villeurbanne (Rhône), December 2018.
Check out the processes underway at the Merck Laboratory in Villeurbanne (Rhône), December 2018. EMMANUEL FOUDROT / REUTERS

Does Merck's laboratories provide information on how many versions of Levothyrox can be substituted after delivery? What was the question, troubled, by one of the most publicly published news 21 years before the revue Clinical Pharmacokinetics.

These are further reanalyzed by the laboratory to change the modulation formula: suggesting that only one bioequivalence of two versions is possible for Merck to conduct a large tail test – sur 204 Individuals – to perform a classical test, generally on a single track with a voluntary trent. A wireless test kit is intended to be more than just coaxial. More than one probability can be measured to monitor the bioequivalence of the reaction. Choix d 'etchantillon plus large real-time conduit to mask the variability of patients' response to two versions of the drug.

Designed to treat thyroid malignancies, Levothyrox, used by more than 2.5 million people, mostly females, is a medication with a "therapeutic effect on the brain": these are quite variations of the active principle quantity ( levothyroxine) avoids significant repercussions on patients. Conforming to the regulation, Merck deviates to produce a "bioequivalence measure" to assure the sanitary authorities that the transition to the new formula, intervened in March 2017, within the aftereffective interventions.

Article reserved for subscribers Lire aussi Levothyrox: l'étude qui donne raison aux patients

Complications

Les choses are revelated plus complimentary, as suggested by the French-British nouvelle. This type of déjà montré, in April, is the same as Levothyrox's nouvelle formula and is not substitutable for all individuals. In some of the data produced by Merck on the change of formula, the existing guidelines found that more than 60% of individuals enrolled in the study were subject to the "bioequivalence band". This dispersion of the results in the apparatus is explicitly performed in two tests, the equilibrium being equilibrium being called, on the equilibrium test set and not at the individual level.

«This premier article has quatrains attempting to refocus with avon reponse, Explore the pharmacologist Pierre-Louis Toutain (University of London, Ecole Nationale veterinary), coauthor of these guidelines. It does not contradict the remedies in question as to whether it is a substitution problem, and it does not imply that bioequivalence is capable of replication. »


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