{"id":7281,"date":"2024-03-11T10:00:28","date_gmt":"2024-03-11T09:00:28","guid":{"rendered":"https:\/\/eu.bd.com\/iv-news\/?p=7281"},"modified":"2024-02-15T14:46:57","modified_gmt":"2024-02-15T13:46:57","slug":"bonnes-pratiques-applicables-aux-essais-de-phase-1-portant-sur-des-medicaments-experimentaux","status":"publish","type":"post","link":"https:\/\/eu.bd.com\/iv-news\/fr\/actualites-et-innovation\/bonnes-pratiques-applicables-aux-essais-de-phase-1-portant-sur-des-medicaments-experimentaux\/","title":{"rendered":"Bonnes pratiques applicables aux essais de phase\u202f1 portant sur des m\u00e9dicaments exp\u00e9rimentaux"},"content":{"rendered":"<p><span data-contrast=\"auto\">Avant leur mise sur le march\u00e9, les produits pharmaceutiques font l\u2019objet\u00a0 d\u2019un examen approfondi en tant que m\u00e9dicament exp\u00e9rimental (NME ou nouveau m\u00e9dicament exp\u00e9rimental) afin de garantir l&#8217;innocuit\u00e9 de la nouvelle mol\u00e9cule et le respect des r\u00e9glementations.<\/span><sup><span data-contrast=\"auto\">1,2<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><span data-contrast=\"auto\">Contrairement aux m\u00e9dicaments disponibles dans le commerce, le traitement et la distribution s\u00e9curis\u00e9s des m\u00e9dicaments exp\u00e9rimentaux n\u2019ont pas fait l&#8217;objet d&#8217;une normalisation g\u00e9n\u00e9ralis\u00e9e.<\/span><sup><span data-contrast=\"auto\">3<\/span><\/sup><span data-contrast=\"auto\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Lisez la suite pour d\u00e9couvrir les derni\u00e8res recommandations de fabrication et d\u2019administration s\u00e9curis\u00e9es des m\u00e9dicaments exp\u00e9rimentaux.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2 aria-level=\"2\">Dangers associ\u00e9s \u00e0 ces m\u00e9dicaments<\/h2>\n<p><span data-contrast=\"auto\">Les m\u00e9dicaments exp\u00e9rimentaux doivent respecter les bonnes pratiques de fabrication lorsqu\u2019ils font l&#8217;objet d&#8217;essais cliniques de phase\u202f1 car\u00a0 c\u2019est \u00e0 ce stade qu\u2019ils sont pr\u00e9sent\u00e9s pour la premi\u00e8re fois \u00e0 des sujets humains.<\/span><sup><span data-contrast=\"auto\">2,4<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><span data-contrast=\"auto\">Cependant, le risque d&#8217;erreur n&#8217;est pas nul\u202f: <a href=\"https:\/\/www.ismp.org\/about#:~:text=The%20Institute%20for%20Safe%20Medication,professionals%20who%20care%20for%20them.\">l\u2019Institute for Safe Medication Practices (ISMP)<\/a> a constat\u00e9 un risque d&#8217;erreur chez les commanditaires des \u00e9tudes dans les domaines suivants\u202f: pratiques de d\u00e9nomination, notices de m\u00e9dicaments, emballages, aspect des produits et dates d&#8217;expiration.<\/span><sup><span data-contrast=\"auto\">3<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">De plus, les m\u00e9dicaments exp\u00e9rimentaux de phase\u202f1 sont de nouveaux produits chimiques, ce qui signifie que les informations sur leur toxicit\u00e9 potentielle restent souvent limit\u00e9es.<\/span><sup><span data-contrast=\"auto\">5<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><span data-contrast=\"auto\">Selon Valdeolmillos et al., les m\u00e9dicaments exp\u00e9rimentaux doivent \u00eatre consid\u00e9r\u00e9s comme dangereux jusqu&#8217;\u00e0 ce que tout risque soit exclu, \u00ab\u202fcar il est peu fr\u00e9quent de disposer d&#8217;\u00e9tudes de risques et les informations sur la s\u00e9curit\u00e9 sont g\u00e9n\u00e9ralement insuffisantes\u202f\u00bb.<\/span><sup><span data-contrast=\"auto\">6<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">L&#8217;exposition \u00e0 des m\u00e9dicaments dangereux, m\u00eame \u00e0 de faibles concentrations, peut avoir des effets n\u00e9fastes tels que des l\u00e9sions des organes internes, des mutations g\u00e9n\u00e9tiques, des cancers et des taux accrus de troubles de la reproduction.<\/span><sup><span data-contrast=\"auto\">7-12<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2 aria-level=\"2\">S\u00e9curit\u00e9 des essais cliniques de phase\u202f1 portant sur des m\u00e9dicaments exp\u00e9rimentaux<\/h2>\n<p><span data-contrast=\"auto\">Les bonnes pratiques de fabrication de la Food &amp; Drug Administration des \u00c9tats-Unis pour les m\u00e9dicaments exp\u00e9rimentaux de phase\u202f1 comprennent des instructions \u00e9crites rigoureuses en mati\u00e8re de r\u00e9ception, de manipulation, de stockage, de distribution, de r\u00e9cup\u00e9ration et de restitution s\u00e9curis\u00e9s du m\u00e9dicament pendant les essais.<\/span><sup><span data-contrast=\"auto\">13<\/span><\/sup><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">La Directive europ\u00e9enne 2001\/83\/CE, qui d\u00e9finit les exigences relatives aux m\u00e9dicaments \u00e0 usage humain, exige \u00e9galement un r\u00e9sum\u00e9 \u00e9crit\u00a0 d\u00e9taill\u00e9 des caract\u00e9ristiques du produit.<\/span><sup><span data-contrast=\"auto\">2<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Comme pour tous les m\u00e9dicaments dangereux, les\u00a0 bonnes pratiques de fabrication applicables aux \u00c9tats-Unis indiquent \u00e9galement que l&#8217;utilisation de dispositifs de transfert en syst\u00e8me clos, qui garantissent que le m\u00e9dicament exp\u00e9rimental n&#8217;est pas expos\u00e9 \u00e0 l&#8217;environnement pendant le traitement, permet de r\u00e9duire la n\u00e9cessit\u00e9 d&#8217;une classification plus stricte des locaux pour la qualit\u00e9 de l&#8217;air.<\/span><sup><span data-contrast=\"auto\">4<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><span data-contrast=\"auto\">Des \u00e9tudes montrent que l&#8217;utilisation de dispositifs de transfert en syst\u00e8me clos peut contribuer \u00e0 r\u00e9duire la contamination par des m\u00e9dicaments dangereux.<\/span><sup><span data-contrast=\"auto\">7<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Les\u00a0 bonnes pratiques de fabrication europ\u00e9ennes mentionnent qu&#8217;une attention particuli\u00e8re doit \u00eatre\u00a0 accord\u00e9e \u00e0 la s\u00e9curit\u00e9 de la manipulation des m\u00e9dicaments exp\u00e9rimentaux\u00a0 afin d\u2019\u00e9viter toute contamination crois\u00e9e, en soulignant l&#8217;importance de la mise en place d&#8217;un syst\u00e8me de contr\u00f4le\u00a0 qualit\u00e9 suffisant.<\/span><sup><span data-contrast=\"auto\">14<\/span><\/sup><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Plus d\u2019informations \u00e0 ce sujet\u202f:\u00a0<\/span><\/b><a href=\"https:\/\/eu.bd.com\/iv-news\/fr\/actualites-et-innovation\/comment-pouvez-vous-vous-proteger-des-effets-nocifs-potentiels-des-medicaments-non-oncologiques\/\">Comment pouvez-vous vous prot\u00e9ger des effets nocifs potentiels des m\u00e9dicaments non oncologiques ?<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Avant leur mise sur le march\u00e9, les produits pharmaceutiques font l\u2019objet\u00a0 d\u2019un examen approfondi en tant que m\u00e9dicament exp\u00e9rimental (NME&#8230;<\/p>\n","protected":false},"author":8,"featured_media":7285,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[748],"tags":[],"class_list":["post-7281","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites-et-innovation","speciality-equipe-operationnelle-dhygiene","speciality-preparation-de-medicaments","speciality-securite-des-soignants","speciality-securite-du-patient","contenttype-article-fr","target-approvisionnement","target-directeur-responsable-dhopital","target-equipe-operationnelle-dhygiene","target-medecin","target-pharmacie-clinique","target-soins-infirmiers"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bonnes pratiques applicables aux essais de phase\u202f1 portant sur des m\u00e9dicaments 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