{"id":7870,"date":"2023-10-25T10:46:07","date_gmt":"2023-10-25T09:46:07","guid":{"rendered":"https:\/\/leckiepharma.com\/?page_id=7870"},"modified":"2023-11-08T06:40:00","modified_gmt":"2023-11-08T06:40:00","slug":"rd","status":"publish","type":"page","link":"https:\/\/leckiepharma.com\/index.php\/rd\/","title":{"rendered":"R&#038;D"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7870\" class=\"elementor elementor-7870\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ab3899c elementor-section-full_width elementor-section-stretched elementor-section-height-default elementor-section-height-default\" data-id=\"ab3899c\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-23e6cda\" data-id=\"23e6cda\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fdb4b78 elementor-widget elementor-widget-image\" data-id=\"fdb4b78\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t<div class=\"elementor-image\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" width=\"1600\" height=\"1000\" src=\"https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM.jpeg\" class=\"attachment-full size-full wp-image-8006\" alt=\"\" srcset=\"https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM.jpeg 1600w, https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM-300x188.jpeg 300w, https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM-1024x640.jpeg 1024w, https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM-768x480.jpeg 768w, https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM-1536x960.jpeg 1536w, https:\/\/leckiepharma.com\/wp-content\/uploads\/2023\/10\/WhatsApp-Image-2023-10-26-at-2.17.12-PM-600x375.jpeg 600w\" sizes=\"(max-width: 1600px) 100vw, 1600px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\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-b028902 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b028902\" 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\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-baa2e16\" data-id=\"baa2e16\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e5c5198 elementor-widget elementor-widget-heading\" data-id=\"e5c5198\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Research And Development<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\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-36424ae elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"36424ae\" 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\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e393ae2\" data-id=\"e393ae2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0bb5b93 elementor-widget elementor-widget-text-editor\" data-id=\"0bb5b93\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Leckie Pharma UK is specialized in product development and filing at international regulatory bodies like the USFDA and UK MHRA.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\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-31ae705 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31ae705\" 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\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b63945e\" data-id=\"b63945e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9911761 elementor-widget elementor-widget-heading\" data-id=\"9911761\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">The new molecules filing includes a preclinical trial on non-human subjects and 4 other clinical trials as follows:<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\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-6637d40 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6637d40\" 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\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-62739a3\" data-id=\"62739a3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-09e211e elementor-widget elementor-widget-text-editor\" data-id=\"09e211e\" data-element_type=\"widget\" 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<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<ul>\n<li>Phase I clinical trials typically are conducted with a small number of healthy volunteers, typically fewer than 100, to determine the safety, tolerability, and pharmacokinetics, and pharmacodynamics of the potential drug.<\/li>\n<li>Phase II clinical trials begin if the drug successfully passes Phase I testing. This phase generally involves between 100 and 500 participants to assess the efficacy of the drug.<\/li>\n<li>Phase III clinical trials are initiated if the potential new medicine is found to be both safe and efficacious through Phases I and II testing. Phase III trials may enroll 1,000 to 5,000 patients or more across numerous clinical trials sites across states and around the world. These randomized, controlled trials generate large amounts of data to support submission to the FDA for approval.<\/li>\n<li>FDA regulatory review and approval involves the submission of the data collected from<\/li>\n<li>Phase IV involves post-marketing pharmacovigilance monitoring.<\/li>\n<\/ul>\n<p><\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\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-e2e1c68 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e2e1c68\" 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\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2b8e918\" data-id=\"2b8e918\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d15c411 elementor-widget elementor-widget-heading\" data-id=\"d15c411\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">The Generic molecule<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\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-27675bb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"27675bb\" 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\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4a674ea\" data-id=\"4a674ea\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b9ee728 elementor-widget elementor-widget-text-editor\" data-id=\"b9ee728\" data-element_type=\"widget\" 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<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Leckie Pharma UK follows the Hatch-Waxman by which we apply the abbreviated new drug applications (ANDAs), which permits generic pharmaceutical manufacturers to build on FDA\u2019s prior approval of the brand drug with the same ingredients to establish the safety and efficacy of their generics. a bioequivalent study between the generic and the brand originator product demonstrating that both drugs have the same pharmacokinetic (absorption, distribution, metabolism, and excretion) properties inside the human body. In addition, ANDA requires generic proposed labeling to be identical to the originator labeling except for manufacturing information or other changes that have been approved and added.<\/p><p>\u00a0<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Research And Development Leckie Pharma UK is specialized in product development and filing at international regulatory bodies like the USFDA and UK MHRA. The new molecules filing includes a preclinical trial on non-human subjects and 4 other clinical trials as follows: Phase I clinical trials typically are conducted with a small number of healthy volunteers, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>R&amp;D - leckiepharma.com<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/leckiepharma.com\/index.php\/rd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R&amp;D - leckiepharma.com\" \/>\n<meta property=\"og:description\" content=\"Research And Development Leckie Pharma UK is specialized in product development and filing at international regulatory bodies like the USFDA and UK MHRA. 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