{
    "id": 5152,
    "date": "2026-09-09T23:54:15",
    "date_gmt": "2026-09-09T21:54:15",
    "guid": {
        "rendered": "https:\/\/www.phinc-group.com\/?p=5152"
    },
    "modified": "2026-09-10T10:22:18",
    "modified_gmt": "2026-09-10T08:22:18",
    "slug": "pbbm-connecting-drug-product-performance-to-clinical-outcomes",
    "status": "publish",
    "type": "post",
    "link": "https:\/\/www.phinc-group.com\/fr\/pbbm-connecting-drug-product-performance-to-clinical-outcomes\/",
    "title": {
        "rendered": "PBBM : Relier les performances du produit m\u00e9dicamenteux aux r\u00e9sultats cliniques"
    },
    "content": {
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ol{display:grid;grid-template-columns:repeat(2,1fr);gap:0 24px;}\r\n}\r\n@media (max-width:860px){\r\n  .pbbm-hero-grid{grid-template-columns:1fr;}\r\n  .pbbm-toc ol{grid-template-columns:1fr;}\r\n  .pbbm-hero h1{font-size:34px;max-width:100%;}\r\n  .pbbm-hero .pbbm-subtitle{max-width:100%;margin-bottom:24px;}\r\n  .pbbm-cards{grid-template-columns:1fr;}\r\n  .pbbm-shift{grid-template-columns:1fr;}\r\n  .pbbm-quote{padding:36px 28px;}\r\n  .pbbm-cta{padding:56px 28px;}\r\n}\r\n<\/style>\r\n\r\n<div class=\"pbbm-container\">\r\n\r\n  <!-- HERO -->\r\n  <section class=\"pbbm-hero\">\r\n    <div class=\"pbbm-hero-grid\">\r\n      <div>\r\n        <span class=\"pbbm-eyebrow\"><span class=\"pbbm-dot\"><\/span>Biopharmacie &amp; PBBM<\/span>\r\n        <h1>PBBM : relier les performances du produit m\u00e9dicamenteux aux <em>r\u00e9sultats cliniques<\/em><\/h1>\r\n        <p class=\"pbbm-subtitle\">La mod\u00e9lisation biopharmaceutique bas\u00e9e sur la physiologie (PBBM - Physiologically Based Biopharmaceutics Modeling) n'est plus un outil exploratoire p\u00e9riph\u00e9rique ; elle s'est impos\u00e9e comme un pilier central du d\u00e9veloppement moderne des formulations et comme une composante de plus en plus importante du d\u00e9veloppement de m\u00e9dicaments guid\u00e9 par des mod\u00e8les (MIDD) et de la prise de d\u00e9cision r\u00e9glementaire.<\/p>\r\n        <div class=\"pbbm-meta-row\">\r\n          <span class=\"pbbm-meta-pill\">FDA \u00b7 EMA<\/span>\r\n          <span class=\"pbbm-meta-pill\">Dissolution in vitro \u00b7 PK in vivo<\/span>\r\n          \r\n        <\/div>\r\n      <\/div>\r\n      <!-- VISUEL IMG-01 -->\r\n      <figure class=\"pbbm-visual pbbm-hero-visual\">\r\n        <img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/comprime-performances-resultats-phinc-PBBM.png\"\r\n             alt=\"Comprim\u00e9 se dissolvant en particules lumineuses se prolongeant en courbe pharmacocin\u00e9tique\"\r\n             width=\"1200\" height=\"900\">\r\n      <\/figure>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <div class=\"pbbm-body\">\r\n\r\n  <!-- SOMMAIRE -->\r\n  <nav class=\"pbbm-toc\" aria-label=\"Sommaire\">\r\n    <p class=\"pbbm-toc-title\">Sommaire<\/p>\r\n    <ol>\r\n      <li><a href=\"#pbbm-s1\">Le changement de paradigme en biopharmacie<\/a><\/li>\r\n      <li><a href=\"#pbbm-s2\">Construire un mod\u00e8le PBBM cr\u00e9dible<\/a><\/li>\r\n      <li><a href=\"#pbbm-s3\">O\u00f9 la PBBM cr\u00e9e de la valeur<\/a><\/li>\r\n      <li><a href=\"#pbbm-s4\">Bonnes pratiques pour les promoteurs<\/a><\/li>\r\n      <li><a href=\"#pbbm-conclusion\">Conclusion<\/a><\/li>\r\n      <li><a href=\"#pbbm-refs\">R\u00e9f\u00e9rences<\/a><\/li>\r\n    <\/ol>\r\n  <\/nav>\r\n\r\n  <div class=\"pbbm-main\">\r\n\r\n  <section class=\"pbbm-section\" style=\"padding-top:0;\">\r\n    <p>En s'appuyant sur des mod\u00e8les m\u00e9canistes pour relier les donn\u00e9es de dissolution in vitro \u00e0 la pharmacocin\u00e9tique (PK) in vivo, les promoteurs peuvent relier avec succ\u00e8s les performances du produit m\u00e9dicamenteux aux r\u00e9sultats cliniques. Cela permet ainsi d'orienter le d\u00e9veloppement de la formulation, de r\u00e9duire les exp\u00e9rimentations cliniques inutiles, d'optimiser les produits m\u00e9dicamenteux et d'am\u00e9liorer la s\u00e9curit\u00e9 des patients <sup>[4, 5]<\/sup>.<\/p>\r\n    <p>Fondamentalement, la PBBM r\u00e9pond \u00e0 une question critique dans le d\u00e9veloppement des m\u00e9dicaments : <strong>une diff\u00e9rence observ\u00e9e in vitro aura-t-elle r\u00e9ellement une importance chez le patient ?<\/strong> \u00c0 mesure que son utilisation s'\u00e9tend au sein du d\u00e9veloppement et de la prise de d\u00e9cision r\u00e9glementaire, la cr\u00e9dibilit\u00e9, la transparence et l'ad\u00e9quation \u00e0 l'objectif du mod\u00e8le sont devenues de plus en plus cruciales <sup>[3]<\/sup>.<\/p>\r\n  <\/section>\r\n\r\n  <hr class=\"pbbm-divider\">\r\n\r\n  <!-- SECTION 1 -->\r\n  <section class=\"pbbm-section pbbm-anchor\" id=\"pbbm-s1\">\r\n    <span class=\"pbbm-kicker\">Contexte<\/span>\r\n    <h2>Le changement de paradigme en <em>biopharmacie<\/em><\/h2>\r\n    <p>Au cours de la derni\u00e8re d\u00e9cennie, la biopharmacie a progressivement \u00e9volu\u00e9 au-del\u00e0 des corr\u00e9lations in vitro-in vivo (CIVIV \/ IVIVC) empiriques traditionnelles pour s'orienter vers des approches PBBM plus m\u00e9canistes. La PBBM \u00e9tablit un pont quantitatif \u00e0 travers le continuum suivant :<\/p>\r\n\r\n    <div class=\"pbbm-flow-box\">\r\n      <p class=\"pbbm-flow-label\">Le pont quantitatif \u00e9tabli par la PBBM<\/p>\r\n      <ul class=\"pbbm-flow\">\r\n        <li>Produit m\u00e9dicamenteux<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Dissolution \/ Lib\u00e9ration<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Physiologie gastro-intestinale<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Absorption<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Exposition syst\u00e9mique<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li class=\"pbbm-end\">Performance clinique<\/li>\r\n      <\/ul>\r\n    <\/div>\r\n\r\n    <p>Cela repr\u00e9sente un changement majeur. Une diff\u00e9rence in vitro ne se traduit pas n\u00e9cessairement par une diff\u00e9rence cliniquement significative ; inversement, des modifications de la formulation, de la taille des particules, du proc\u00e9d\u00e9 de fabrication ou du comportement de dissolution peuvent affecter de mani\u00e8re significative l'exposition pour certains compos\u00e9s. <strong>La PBBM fournit un cadre permettant de comprendre quand ces diff\u00e9rences ont une incidence.<\/strong><\/p>\r\n\r\n    <p>La Food and Drug Administration (FDA) des \u00c9tats-Unis a formalis\u00e9 ses attentes par le biais de directives sp\u00e9cifiques sur l'utilisation de la PBBM pour soutenir les demandes biopharmaceutiques <sup>[1]<\/sup>. De m\u00eame, l'Agence europ\u00e9enne des m\u00e9dicaments (EMA) et d'autres autorit\u00e9s de sant\u00e9 mondiales collaborent avec les promoteurs sur l'utilisation d'approches de mod\u00e9lisation m\u00e9caniste pour soutenir le d\u00e9veloppement de m\u00e9dicaments et les d\u00e9cisions r\u00e9glementaires <sup>[2]<\/sup>.<\/p>\r\n\r\n    <div class=\"pbbm-quote\">\r\n      <span class=\"pbbm-quote-mark\">&rdquo;<\/span>\r\n      <p>Un mod\u00e8le PBBM cr\u00e9dible doit \u00eatre rigoureusement param\u00e9tr\u00e9, hautement transparent et m\u00e9canistiquement solide pour son contexte d'utilisation pr\u00e9vu.<\/p>\r\n    <\/div>\r\n\r\n    <!-- VISUEL IMG-02 -->\r\n    <figure class=\"pbbm-visual wide\">\r\n      <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/IMG-02-\u2014-Continuum-biopharmaceutique.png\"\r\n           alt=\"Continuum biopharmaceutique : de la dissolution \u00e0 l'exposition syst\u00e9mique\"\r\n           width=\"1600\" height=\"900\">\r\n    <\/figure>\r\n  <\/section>\r\n\r\n  <hr class=\"pbbm-divider\">\r\n\r\n  <!-- SECTION 2 -->\r\n  <section class=\"pbbm-section pbbm-anchor\" id=\"pbbm-s2\">\r\n    <span class=\"pbbm-kicker\">Exigences<\/span>\r\n    <h2>Construire un mod\u00e8le PBBM <em>cr\u00e9dible<\/em><\/h2>\r\n\r\n    <h3>Int\u00e9gration m\u00e9caniste des donn\u00e9es in vitro<\/h3>\r\n    <p>Un principe fondamental est qu'un mod\u00e8le PBBM d\u00e9pend fortement de la qualit\u00e9 de ses donn\u00e9es d'entr\u00e9e. Les promoteurs doivent g\u00e9n\u00e9rer des donn\u00e9es de dissolution in vitro robustes et biopertinentes (biorelevant) plut\u00f4t que de s'appuyer uniquement sur des milieux de contr\u00f4le qualit\u00e9 (CQ) <sup>[5]<\/sup>.<\/p>\r\n    <p>Le mod\u00e8le doit capturer avec pr\u00e9cision les propri\u00e9t\u00e9s physico-chimiques pertinentes de l'ingr\u00e9dient pharmaceutique actif (API \/ principe actif), telles que la solubilit\u00e9 et la perm\u00e9abilit\u00e9, ainsi que les caract\u00e9ristiques de dissolution, de pr\u00e9cipitation et des particules, le cas \u00e9ch\u00e9ant, et les relier de mani\u00e8re dynamique \u00e0 la physiologie gastro-intestinale humaine.<\/p>\r\n\r\n    <h3>V\u00e9rification et validation du mod\u00e8le<\/h3>\r\n    <p>Le niveau de validation requis doit \u00eatre align\u00e9 sur le contexte d'utilisation pr\u00e9vu et sur l'impact de la d\u00e9cision \u00e9tay\u00e9e par le mod\u00e8le <sup>[3]<\/sup>.<\/p>\r\n    <p>Si un mod\u00e8le PBBM est utilis\u00e9 pour justifier une dispense (waiver) d'\u00e9tude clinique pivotale de bio\u00e9quivalence (BE), il est soumis au plus haut niveau de contr\u00f4le. Il est attendu des promoteurs qu'ils \u00e9valuent rigoureusement les performances pr\u00e9dictives en validant le mod\u00e8le par rapport aux donn\u00e9es cliniques de PK issues de plusieurs formulations pr\u00e9sentant des vitesses de lib\u00e9ration variables. L'exactitude pr\u00e9dictive est souvent \u00e9valu\u00e9e \u00e0 l'aide de crit\u00e8res d'acceptation pr\u00e9d\u00e9finis pour des param\u00e8tres pharmacocin\u00e9tiques tels que la C<sub>max<\/sub> et l'ASC (AUC).<\/p>\r\n    <p>Pour des applications \u00e0 plus faible impact, telles que la s\u00e9lection ou l'optimisation pr\u00e9coce d'une formulation, le niveau de preuve requis peut \u00eatre diff\u00e9rent. Dans tous les cas, des analyses de sensibilit\u00e9 et d'incertitude peuvent aider \u00e0 identifier les param\u00e8tres qui d\u00e9terminent les pr\u00e9dictions du mod\u00e8le et orienter la g\u00e9n\u00e9ration de donn\u00e9es exp\u00e9rimentales suppl\u00e9mentaires.<\/p>\r\n\r\n    <h3>D\u00e9finir l'espace de s\u00e9curit\u00e9 (Safe Space)<\/h3>\r\n    <p>L'une des applications les plus pr\u00e9cieuses de la PBBM est sa capacit\u00e9 \u00e0 d\u00e9finir un \u00ab espace de s\u00e9curit\u00e9 \u00bb, \u00e9tablissant ainsi les limites des profils de dissolution in vitro \u00e0 l'int\u00e9rieur desquelles des modifications cliniquement significatives de l'exposition syst\u00e9mique ne sont pas attendues. Cela cr\u00e9e une connexion directe entre :<\/p>\r\n\r\n    <div class=\"pbbm-flow-box\">\r\n      <p class=\"pbbm-flow-label\">La cha\u00eene de causalit\u00e9 couverte par l'espace de s\u00e9curit\u00e9<\/p>\r\n      <ul class=\"pbbm-flow\">\r\n        <li>CMA \/ CPP<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Dissolution<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Absorption<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Exposition<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li class=\"pbbm-end\">Pertinence clinique<\/li>\r\n      <\/ul>\r\n    <\/div>\r\n\r\n    <!-- VISUEL IMG-03 -->\r\n    <figure class=\"pbbm-visual tall\">\r\n      <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/IMG-03-\u2014-Espace-de-securite-2.png\"\r\n           alt=\"Espace de s\u00e9curit\u00e9 : faisceau de profils de dissolution encadr\u00e9 par des limites haute et basse\"\r\n           width=\"1600\" height=\"1200\">\r\n    <\/figure>\r\n\r\n    <p>Ces limites peuvent \u00eatre explor\u00e9es par le biais d'essais cliniques virtuels <sup>[1, 3]<\/sup> et peuvent soutenir le d\u00e9veloppement de la formulation, l'\u00e9tablissement de sp\u00e9cifications cliniquement pertinentes, les changements de fabrication et la gestion du cycle de vie. Il est important de noter que <strong>les limites de l'espace de s\u00e9curit\u00e9 et l'incertitude associ\u00e9e aux pr\u00e9dictions en dehors de la plage valid\u00e9e doivent \u00eatre communiqu\u00e9es de mani\u00e8re transparente<\/strong>.<\/p>\r\n  <\/section>\r\n\r\n  <hr class=\"pbbm-divider\">\r\n\r\n  <!-- SECTION 3 -->\r\n  <section class=\"pbbm-section pbbm-anchor\" id=\"pbbm-s3\">\r\n    <span class=\"pbbm-kicker\">Applications<\/span>\r\n    <h2>O\u00f9 la PBBM cr\u00e9e de la <em>valeur<\/em><\/h2>\r\n    <p>La PBBM peut g\u00e9n\u00e9rer de la valeur tout au long du d\u00e9veloppement du produit m\u00e9dicamenteux, de la s\u00e9lection initiale de la formulation jusqu'\u00e0 la gestion du cycle de vie post-approbation.<\/p>\r\n\r\n    <div class=\"pbbm-cards\">\r\n      <div class=\"pbbm-card\">\r\n        <div class=\"pbbm-icon-chip\">\u2697<\/div>\r\n        <h3>D\u00e9veloppement et optimisation de la formulation<\/h3>\r\n        <p>La PBBM peut aider \u00e0 identifier les attributs physico-chimiques et de formulation les plus susceptibles de limiter l'absorption. Des simulations peuvent d\u00e9terminer si l'am\u00e9lioration de la dissolution est susceptible d'augmenter l'exposition, ou si la perm\u00e9abilit\u00e9, la pr\u00e9cipitation ou un autre m\u00e9canisme constitue le facteur limitant dominant. Cela aide \u00e0 hi\u00e9rarchiser les exp\u00e9rimentations et \u00e0 r\u00e9duire les approches empiriques par t\u00e2tonnement.<\/p>\r\n        <div class=\"pbbm-pill-tags\"><span>Formulation<\/span><span>Solubilit\u00e9 \u00b7 Perm\u00e9abilit\u00e9<\/span><\/div>\r\n      <\/div>\r\n      <div class=\"pbbm-card\">\r\n        <div class=\"pbbm-icon-chip\">\ud83d\udcca<\/div>\r\n        <h3>Sp\u00e9cifications de dissolution cliniquement pertinentes<\/h3>\r\n        <p>La PBBM peut relier les performances de dissolution \u00e0 l'exposition syst\u00e9mique et aider \u00e0 d\u00e9finir des sp\u00e9cifications cliniquement pertinentes (CRDS), garantissant ainsi qu'une variabilit\u00e9 acceptable du produit ne devrait pas affecter de mani\u00e8re significative la performance clinique <sup>[1]<\/sup>.<\/p>\r\n        <div class=\"pbbm-pill-tags\"><span>CRDS<\/span><span>Contr\u00f4le qualit\u00e9<\/span><\/div>\r\n      <\/div>\r\n      <div class=\"pbbm-card\">\r\n        <div class=\"pbbm-icon-chip\">\ud83d\udd04<\/div>\r\n        <h3>Bio\u00e9quivalence virtuelle et transition entre formulations<\/h3>\r\n        <p>La PBBM est un outil pr\u00e9cieux pour la gestion du cycle de vie. La VBE peut aider \u00e0 assurer la transition (bridging) lors de changements de formulation ou de sites de fabrication, tout en r\u00e9duisant potentiellement la n\u00e9cessit\u00e9 d'\u00e9tudes de bio\u00e9quivalence cliniques suppl\u00e9mentaires, lorsque cela est justifi\u00e9 de mani\u00e8re appropri\u00e9e <sup>[3]<\/sup>.<\/p>\r\n        <div class=\"pbbm-pill-tags\"><span>VBE<\/span><span>Cycle de vie<\/span><\/div>\r\n      <\/div>\r\n      <div class=\"pbbm-card\">\r\n        <div class=\"pbbm-icon-chip\">\ud83c\udf7d<\/div>\r\n        <h3>Pr\u00e9dictions de l'effet de la nourriture<\/h3>\r\n        <p>La PBBM peut combler l'\u00e9cart entre les \u00e9tats \u00e0 jeun et nourri en mod\u00e9lisant de mani\u00e8re m\u00e9caniste les temps de transit gastro-intestinal, la s\u00e9cr\u00e9tion de sels biliaires et la solubilisation micellaire <sup>[4]<\/sup>. Au-del\u00e0 de la simple pr\u00e9diction de l'existence d'un effet alimentaire, elle aide \u00e0 expliquer les m\u00e9canismes qui r\u00e9gissent la modification de l'exposition.<\/p>\r\n        <div class=\"pbbm-pill-tags\"><span>Effet alimentaire<\/span><span>Transit GI<\/span><\/div>\r\n      <\/div>\r\n    <\/div>\r\n\r\n    <!-- VISUEL IMG-04 -->\r\n    <figure class=\"pbbm-visual wide\">\r\n      <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/IMG-04-\u2014-Cas-dusage-cycle-de-vie.png\"\r\n           alt=\"Repr\u00e9sentation abstraite du cycle de vie du produit m\u00e9dicamenteux\"\r\n           width=\"1600\" height=\"900\">\r\n    <\/figure>\r\n  <\/section>\r\n\r\n  <hr class=\"pbbm-divider\">\r\n\r\n  <!-- SECTION 4 -->\r\n  <section class=\"pbbm-section pbbm-anchor\" id=\"pbbm-s4\">\r\n    <span class=\"pbbm-kicker\">Bonnes pratiques<\/span>\r\n    <h2>Bonnes pratiques pour les <em>promoteurs<\/em><\/h2>\r\n    <p>Pour maximiser avec succ\u00e8s la valeur scientifique et r\u00e9glementaire de la PBBM, les \u00e9quipes de biopharmacie et les pharmacom\u00e9triciens doivent adopter les bonnes pratiques suivantes :<\/p>\r\n\r\n    <div class=\"pbbm-practice\">\r\n      <span class=\"pbbm-practice-num\">01<\/span>\r\n      <div>\r\n        <h3>Int\u00e9grer pr\u00e9cocement<\/h3>\r\n        <p>N'attendez pas la soumission de la demande d'autorisation de mise sur le march\u00e9 (NDA\/BLA) pour introduire un mod\u00e8le PBBM complexe. L'introduction pr\u00e9coce de la PBBM permet au mod\u00e8le d'\u00e9voluer parall\u00e8lement au d\u00e9veloppement clinique et \u00e0 celui de la formulation. Utilisez les r\u00e9unions avec les agences r\u00e9glementaires, le cas \u00e9ch\u00e9ant, pour obtenir un alignement pr\u00e9coce sur la strat\u00e9gie de mod\u00e9lisation, le choix des milieux biopertinents et l'application r\u00e9glementaire vis\u00e9e.<\/p>\r\n      <\/div>\r\n    <\/div>\r\n    <div class=\"pbbm-practice\">\r\n      <span class=\"pbbm-practice-num\">02<\/span>\r\n      <div>\r\n        <h3>D\u00e9velopper une strat\u00e9gie de param\u00e9trage robuste<\/h3>\r\n        <p>Tout comme les essais cliniques n\u00e9cessitent une planification minutieuse, les efforts li\u00e9s \u00e0 la PBBM doivent \u00eatre encadr\u00e9s par un plan pr\u00e9-sp\u00e9cifi\u00e9. Les param\u00e8tres ascendants (bottom-up - comme la perm\u00e9abilit\u00e9 et la solubilit\u00e9) doivent \u00eatre mesur\u00e9s avec soin, tandis que l'optimisation descendante (top-down) doit \u00eatre scientifiquement justifi\u00e9e et document\u00e9e de mani\u00e8re transparente <sup>[2]<\/sup>.<\/p>\r\n      <\/div>\r\n    <\/div>\r\n    <div class=\"pbbm-practice\">\r\n      <span class=\"pbbm-practice-num\">03<\/span>\r\n      <div>\r\n        <h3>Favoriser la collaboration interfonctionnelle<\/h3>\r\n        <p>Une strat\u00e9gie PBBM r\u00e9ussie est rarement l'\u0153uvre d'un seul scientifique. Elle n\u00e9cessite une int\u00e9gration \u00e9troite entre les formulateurs, les chimistes analytiques g\u00e9n\u00e9rant les donn\u00e9es de dissolution, les mod\u00e9lisateurs construisant l'architecture du mod\u00e8le, et les pharmacologues cliniques interpr\u00e9tant l'impact sur l'exposition. La strat\u00e9gie de mod\u00e9lisation finale doit traduire des r\u00e9sultats m\u00e9canistes complexes en informations de d\u00e9veloppement de m\u00e9dicaments claires et exploitables.<\/p>\r\n      <\/div>\r\n    <\/div>\r\n\r\n    <p style=\"margin-top:32px;\">La PBBM est \u00e9galement d'autant plus puissante lorsqu'elle est int\u00e9gr\u00e9e \u00e0 une strat\u00e9gie MIDD plus globale. Associ\u00e9e \u00e0 la pharmacocin\u00e9tique physiologique (PBPK), \u00e0 la PK de population et \u00e0 la mod\u00e9lisation PK\/PD ou exposition-r\u00e9ponse, elle peut contribuer \u00e0 un continuum quantitatif :<\/p>\r\n\r\n    <div class=\"pbbm-flow-box\">\r\n      <p class=\"pbbm-flow-label\">Le continuum quantitatif MIDD<\/p>\r\n      <ul class=\"pbbm-flow\">\r\n        <li>Substance m\u00e9dicamenteuse<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Produit m\u00e9dicamenteux<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Absorption<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>Exposition<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li>R\u00e9ponse<\/li><li class=\"pbbm-arrow\" aria-hidden=\"true\">\u2192<\/li>\r\n        <li class=\"pbbm-end\">R\u00e9sultat clinique<\/li>\r\n      <\/ul>\r\n    <\/div>\r\n\r\n    <p>Au sein de ce continuum, la PBBM constitue un pont particuli\u00e8rement important entre les sciences pharmaceutiques et la pharmacologie clinique.<\/p>\r\n  <\/section>\r\n\r\n  <hr class=\"pbbm-divider\">\r\n\r\n  <!-- CONCLUSION -->\r\n  <section class=\"pbbm-section pbbm-anchor\" id=\"pbbm-conclusion\">\r\n    <span class=\"pbbm-kicker\">Conclusion<\/span>\r\n    <h2>De la diff\u00e9rence in vitro \u00e0 la <em>pertinence clinique<\/em><\/h2>\r\n    <p>\u00c0 mesure que le d\u00e9veloppement des produits m\u00e9dicamenteux gagne en complexit\u00e9, la PBBM offre une approche scientifiquement rigoureuse pour comprendre comment les caract\u00e9ristiques du produit se traduisent en performances in vivo, pour att\u00e9nuer les risques li\u00e9s aux changements de formulation et de fabrication, et pour soutenir des d\u00e9cisions de d\u00e9veloppement plus \u00e9clair\u00e9es.<\/p>\r\n    <p>Lorsqu'elle est d\u00e9velopp\u00e9e et appliqu\u00e9e de mani\u00e8re appropri\u00e9e, la PBBM peut soutenir l'optimisation de la formulation, l'\u00e9tablissement de sp\u00e9cifications de dissolution cliniquement pertinentes, la d\u00e9finition de l'espace de s\u00e9curit\u00e9, la bio\u00e9quivalence virtuelle, l'\u00e9valuation de l'effet de la nourriture, les modifications de formulation et de fabrication, la strat\u00e9gie r\u00e9glementaire ainsi que la gestion du cycle de vie.<\/p>\r\n\r\n    <div class=\"pbbm-shift\">\r\n      <div>\r\n        <p class=\"pbbm-shift-label\">La question d'hier<\/p>\r\n        <p class=\"pbbm-shift-q\">\u00ab Ce produit m\u00e9dicamenteux semble-t-il diff\u00e9rent in vitro ? \u00bb<\/p>\r\n      <\/div>\r\n      <div class=\"pbbm-after\">\r\n        <p class=\"pbbm-shift-label\">La question qui compte<\/p>\r\n        <p class=\"pbbm-shift-q\">\u00ab Cette diff\u00e9rence aura-t-elle une importance in vivo ? \u00bb<\/p>\r\n      <\/div>\r\n    <\/div>\r\n\r\n    <p>C'est pr\u00e9cis\u00e9ment dans cette connexion entre les performances du produit m\u00e9dicamenteux et la pertinence clinique que la PBBM peut avoir son impact le plus d\u00e9cisif sur le d\u00e9veloppement moderne des m\u00e9dicaments.<\/p>\r\n  <\/section>\r\n\r\n  <!-- CTA -->\r\n  <section class=\"pbbm-cta\">\r\n    <h2>\u00c9valuez le potentiel de la <em>PBBM<\/em> pour votre produit<\/h2>\r\n    <p>L'\u00e9quipe PhinC accompagne les promoteurs dans la construction, la validation et la documentation de leurs mod\u00e8les PBBM et PBPK, de la strat\u00e9gie de formulation au dossier r\u00e9glementaire.<\/p>\r\n    <div class=\"pbbm-cta-buttons\">\r\n      <a href=\"\/fr\/midd\/\" class=\"pbbm-btn primary\">D\u00e9couvrir nos expertises<\/a>\r\n      <a href=\"\/fr\/contact\/\" class=\"pbbm-btn ghost\">Nous contacter<\/a>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <!-- R\u00c9F\u00c9RENCES -->\r\n  <section class=\"pbbm-section pbbm-anchor\" id=\"pbbm-refs\">\r\n    <span class=\"pbbm-kicker\">R\u00e9f\u00e9rences<\/span>\r\n    <div class=\"pbbm-refs\">\r\n      <ol>\r\n        <li>U.S. Food and Drug Administration (FDA). (2020). <em>The Use of Physiologically Based Pharmacokinetic Analyses \u2014 Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls.<\/em> Draft Guidance for Industry.<\/li>\r\n        <li>European Medicines Agency (EMA). (2018). <em>Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation.<\/em><\/li>\r\n        <li>Suarez-Sharp, S., et al. (2018). Regulatory Experience with Physiologically Based Pharmacokinetic Modeling for Biopharmaceutics Applications. <em>The AAPS Journal<\/em>, 20(4), 68.<\/li>\r\n        <li>Darwich, A. S., et al. (2017). PBPK Modelling of Oral Drug Absorption: Current Status and Future Directions. <em>Clinical Pharmacokinetics<\/em>, 56(11), 1269-1279.<\/li>\r\n        <li>Kostewicz, E. S., et al. (2014). PBPK models for the prediction of in vivo performance of oral dosage forms. <em>European Journal of Pharmaceutical Sciences<\/em>, 57, 300-321.<\/li>\r\n      <\/ol>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <\/div><!-- \/.pbbm-main -->\r\n  <\/div><!-- \/.pbbm-body -->\r\n\r\n<\/div>\r\n\r\n<script>\r\n(function(){\r\n  var links = document.querySelectorAll('.pbbm-toc a');\r\n  var targets = [];\r\n  links.forEach(function(a){\r\n    var el = document.querySelector(a.getAttribute('href'));\r\n    if(el) targets.push({link:a, el:el});\r\n  });\r\n  if(!targets.length || !('IntersectionObserver' in window)) return;\r\n  var obs = new IntersectionObserver(function(entries){\r\n    entries.forEach(function(e){\r\n      if(e.isIntersecting){\r\n        links.forEach(function(l){ l.classList.remove('is-active'); });\r\n        var m = targets.find(function(t){ return t.el === e.target; });\r\n        if(m) m.link.classList.add('is-active');\r\n      }\r\n    });\r\n  }, {rootMargin:'-15% 0px -70% 0px', threshold:0});\r\n  targets.forEach(function(t){ obs.observe(t.el); });\r\n})();\r\n<\/script>\r\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>",
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        "rendered": "<p>La mod\u00e9lisation biopharmaceutique bas\u00e9e sur la physiologie (PBBM &#8211; Physiologically Based Biopharmaceutics Modeling) n&rsquo;est plus un outil exploratoire p\u00e9riph\u00e9rique ; elle s&rsquo;est impos\u00e9e comme un pilier central du d\u00e9veloppement moderne des formulations et comme une composante de plus en plus importante du d\u00e9veloppement de m\u00e9dicaments guid\u00e9 par des mod\u00e8les<\/p>",
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