{"id":921,"date":"2023-07-15T10:26:27","date_gmt":"2023-07-15T07:26:27","guid":{"rendered":"https:\/\/www.rcph.gr\/?page_id=921"},"modified":"2023-08-30T09:58:13","modified_gmt":"2023-08-30T06:58:13","slug":"bioequivalence","status":"publish","type":"page","link":"https:\/\/www.rcph.gr\/en\/bioequivalence\/","title":{"rendered":"Bioequivalence studies"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"921\" class=\"elementor elementor-921\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5d43c2d6 elementor-section-full_width elementor-section-stretched elementor-section-height-default elementor-section-height-default\" data-id=\"5d43c2d6\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ec1d6e4\" data-id=\"ec1d6e4\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aed0f3e elementor-widget elementor-widget-slider_revolution\" data-id=\"aed0f3e\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"slider_revolution.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\r\n\t\t<div class=\"wp-block-themepunch-revslider\">\n\t\t\t<!-- START bioequivalence studies REVOLUTION SLIDER 6.6.14 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"contact_wrapper\" data-source=\"gallery\" 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(window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"contact\"]!==undefined) {window.RS_MODULES.modules[\"contact\"].once = false;window.revapi50 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\r\n\r\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4dea9515 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4dea9515\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-29c70473\" data-id=\"29c70473\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-3b2dca3e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b2dca3e\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-15353b1f\" data-id=\"15353b1f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-37909dd0 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"37909dd0\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;,&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"630\" src=\"https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/bioequivalence-studies-how-to-streamline-generic-drug-approval-process.webp\" class=\"attachment-full size-full wp-image-952\" alt=\"\" srcset=\"https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/bioequivalence-studies-how-to-streamline-generic-drug-approval-process.webp 1200w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/bioequivalence-studies-how-to-streamline-generic-drug-approval-process-300x158.webp 300w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/bioequivalence-studies-how-to-streamline-generic-drug-approval-process-1024x538.webp 1024w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/bioequivalence-studies-how-to-streamline-generic-drug-approval-process-768x403.webp 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61cb1085 elementor-widget elementor-widget-text-editor\" data-id=\"61cb1085\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Evaluation<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a1ef533 elementor-widget elementor-widget-heading\" data-id=\"4a1ef533\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Types of Studies<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4e6ef970 elementor-drop-cap-yes elementor-drop-cap-view-default elementor-widget elementor-widget-text-editor\" data-id=\"4e6ef970\" data-element_type=\"widget\" data-settings=\"{&quot;drop_cap&quot;:&quot;yes&quot;,&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The assessment of the BE of two medicinal products is based on the fundamental assumption that two medicinal products are equivalent when the rate and extent of absorption of the test product does not differ significantly from that of the reference medicinal product when the two medicinal products are taken simultaneously.<\/p><p>BE studies are generally recommended using the following endpoints, listed in order of preference:<\/p><ul><li>Pharmacokinetic studies<\/li><li>Pharmacodynamic studies<\/li><li>Significant Clinical Trials<\/li><li>In vitro dissolution studies<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1076cdd elementor-invisible elementor-widget elementor-widget-image\" data-id=\"1076cdd\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;,&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1200\" height=\"630\" src=\"https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/efficiency-effectiveness-how-to-design.jpg\" class=\"attachment-full size-full wp-image-954\" alt=\"\" srcset=\"https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/efficiency-effectiveness-how-to-design.jpg 1200w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/efficiency-effectiveness-how-to-design-300x158.jpg 300w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/efficiency-effectiveness-how-to-design-1024x538.jpg 1024w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/efficiency-effectiveness-how-to-design-768x403.jpg 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-17fd06a6\" data-id=\"17fd06a6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2a8a7826 elementor-widget elementor-widget-text-editor\" data-id=\"2a8a7826\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Introduction<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4e38a22c elementor-widget elementor-widget-heading\" data-id=\"4e38a22c\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Bioequivalence<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26024994 elementor-drop-cap-yes elementor-drop-cap-view-default elementor-widget elementor-widget-text-editor\" data-id=\"26024994\" data-element_type=\"widget\" data-settings=\"{&quot;drop_cap&quot;:&quot;yes&quot;,&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The absence of significant differences in the bioavailability of the active component at the medicine's action is characterized as bioequivalence, which is widely used to determine similarity between a generic pharmaceutical product and the reference drug.<\/p><p>The plasma concentration-time curve is commonly used in BE studies to determine the pace and degree of absorption. The area under the concentration-time curve, or AUC, represents the degree of exposure. The absorption rate influences Cmax, the highest concentration or peak plasma exposure, and tmax, the time to peak plasma concentration.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c789901 elementor-hidden-phone elementor-invisible elementor-widget elementor-widget-image\" data-id=\"3c789901\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;,&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1200\" height=\"630\" src=\"https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/cell-gene-therapies-is-quality-by-design-ready-for-it.jpg\" class=\"attachment-full size-full wp-image-953\" alt=\"\" srcset=\"https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/cell-gene-therapies-is-quality-by-design-ready-for-it.jpg 1200w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/cell-gene-therapies-is-quality-by-design-ready-for-it-300x158.jpg 300w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/cell-gene-therapies-is-quality-by-design-ready-for-it-1024x538.jpg 1024w, https:\/\/www.rcph.gr\/wp-content\/uploads\/2023\/07\/cell-gene-therapies-is-quality-by-design-ready-for-it-768x403.jpg 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-589a47c elementor-widget elementor-widget-text-editor\" data-id=\"589a47c\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Comparison products<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dcee409 elementor-widget elementor-widget-heading\" data-id=\"dcee409\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">for Bioequivalence studies<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f59fdd3 elementor-drop-cap-yes elementor-drop-cap-view-default elementor-widget elementor-widget-text-editor\" data-id=\"f59fdd3\" data-element_type=\"widget\" data-settings=\"{&quot;drop_cap&quot;:&quot;yes&quot;,&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Pre-marketing research and post-marketing monitoring plans extensively examined and documented the quality, safety, and efficacy of the unique product, which was granted marketing authorization for the first time. As a result, the innovative product is the most appropriate comparison for establishing interchangeability. Indeed, if a new product is available, a generic pharmaceutical product should not be utilized as a comparative. The risk of utilizing a generic pharmaceutical product as a comparator rather than the innovative product is that no assurance can be given that future multi-source products are bioequivalent to the novel product, leading in a lack of interchangeability with the innovative product.<\/p><p>Prototype - innovative pharmaceutical products are approved by international and local organisations (FDA - EMA - EOF) that are responsible for evaluating their quality, safety and efficacy.<br \/>To be more precise, before the product is put on the market, the assessment authorities evaluate the research that the pharmaceutical businesses presented to them. Then, the authorization is given.<br \/>Generic products must submit studies to the evaluation authorities to show their bioequivalence with the original drugs in order to receive marketing authorization. In the bioequivalence research, only the original products may be used as a comparator.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>\u0391\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03a4\u03cd\u03c0\u03bf\u03b9 \u03bc\u03b5\u03bb\u03b5\u03c4\u03ce\u03bd \u0397 \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03c4\u03b7\u03c2 \u0392\u0395 \u03b4\u03cd\u03bf \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03b2\u03b1\u03c3\u03af\u03b6\u03b5\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b7 \u03b8\u03b5\u03bc\u03b5\u03bb\u03b9\u03ce\u03b4\u03b7 \u03c5\u03c0\u03cc\u03b8\u03b5\u03c3\u03b7 \u03cc\u03c4\u03b9 \u03b4\u03cd\u03bf \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ac \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1 \u03b5\u03af\u03bd\u03b1\u03b9 \u03b9\u03c3\u03bf\u03b4\u03cd\u03bd\u03b1\u03bc\u03b1, \u03cc\u03c4\u03b1\u03bd \u03bf \u03c1\u03c5\u03b8\u03bc\u03cc\u03c2 \u03ba\u03b1\u03b9 \u03b7 \u03ad\u03ba\u03c4\u03b1\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03b1\u03c0\u03bf\u03c1\u03c1\u03cc\u03c6\u03b7\u03c3\u03b7\u03c2 \u03c4\u03bf\u03c5 \u03c5\u03c0\u03cc \u03b4\u03bf\u03ba\u03b9\u03bc\u03ae \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03bf\u03c2 \u03b4\u03b5\u03bd \u03b4\u03b9\u03b1\u03c6\u03ad\u03c1\u03b5\u03b9 \u03c3\u03b7\u03bc\u03b1\u03bd\u03c4\u03b9\u03ba\u03ac \u03b1\u03c0\u03cc \u03b1\u03c5\u03c4\u03cc\u03bd \u03c4\u03bf\u03c5 \u03c6\u03b1\u03c1\u03bc\u03ac\u03ba\u03bf\u03c5 \u03b1\u03bd\u03b1\u03c6\u03bf\u03c1\u03ac\u03c2, \u03cc\u03c4\u03b1\u03bd \u03c4\u03b1 \u03b4\u03cd\u03bf \u03c6\u03ac\u03c1\u03bc\u03b1\u03ba\u03b1 \u03c7\u03bf\u03c1\u03b7\u03b3\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03c4\u03b1\u03c5\u03c4\u03cc\u03c7\u03c1\u03bf\u03bd\u03b1. \u039f\u03b9 \u03bc\u03b5\u03bb\u03ad\u03c4\u03b5\u03c2 BE \u03b3\u03b5\u03bd\u03b9\u03ba\u03ac \u03c3\u03c5\u03bd\u03b9\u03c3\u03c4\u03ce\u03bd\u03c4\u03b1\u03b9 \u03c7\u03c1\u03b7\u03c3\u03b9\u03bc\u03bf\u03c0\u03bf\u03b9\u03ce\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b1 \u03b1\u03ba\u03cc\u03bb\u03bf\u03c5\u03b8\u03b1 \u03c4\u03b5\u03bb\u03b9\u03ba\u03ac &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.rcph.gr\/en\/bioequivalence\/\"> <span class=\"screen-reader-text\">Bioequivalence studies<\/span> Read More &raquo;<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"_mi_skip_tracking":false,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-921","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/pages\/921","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/comments?post=921"}],"version-history":[{"count":40,"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/pages\/921\/revisions"}],"predecessor-version":[{"id":2005,"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/pages\/921\/revisions\/2005"}],"wp:attachment":[{"href":"https:\/\/www.rcph.gr\/en\/wp-json\/wp\/v2\/media?parent=921"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}