{"id":2377,"date":"2026-06-01T06:14:34","date_gmt":"2026-06-01T06:14:34","guid":{"rendered":"https:\/\/unimed.bg\/?p=2377"},"modified":"2026-06-01T06:15:19","modified_gmt":"2026-06-01T06:15:19","slug":"kolko-vreme-otnema-razrabotvaneto-na-novo-lekarstvo-ot-laboratoriyata-do-paczienta","status":"publish","type":"post","link":"https:\/\/unimed.bg\/en\/kolko-vreme-otnema-razrabotvaneto-na-novo-lekarstvo-ot-laboratoriyata-do-paczienta\/","title":{"rendered":"How long does it take to develop a new drug: from lab to patient"},"content":{"rendered":"<p class=\"wp-block-paragraph\">When we hear about a new drug, we often imagine that it is the result of several years of work in a laboratory. In reality, developing a new medicine is one of the longest and most complex processes in modern medicine.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">From the initial idea until the treatment reaches the patients, it can take <strong>between 10 and 15 years<\/strong>, and sometimes more. That is why <strong>clinical trials<\/strong> play such an important role in the development of new therapies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How the development of a new drug begins<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">It all starts with a scientific idea or discovery.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The researchers identified:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>a new biological mechanism;<\/li>\n\n\n\n<li>molecule with potential therapeutic effect;<\/li>\n\n\n\n<li>a new approach to treating a particular disease.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Thousands of potential substances can be explored at this stage, but only a small fraction make it to the next stages.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Preclinical studies<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Before a drug is tested in humans, it goes through so-called preclinical studies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">These include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>laboratory tests;<\/li>\n\n\n\n<li>cellular models;<\/li>\n\n\n\n<li>studies on biological systems;<\/li>\n\n\n\n<li>safety and toxicity assessment.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This stage usually takes between 3 and 6 years.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Many potential drugs are dropped right here if they do not show sufficient effectiveness or safety.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Clinical trials - the most important step<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">After the successful completion of preclinical studies begin <strong>clinical trials<\/strong>, evaluating the safety and effectiveness of therapy in humans.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Phase 1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A small number of volunteers participated in the first phase.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The aim is to establish:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>drug safety;<\/li>\n\n\n\n<li>appropriate dosages;<\/li>\n\n\n\n<li>the way the body processes it.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Phase 2<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The second phase involves patients with the relevant disease.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Here are evaluated:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>the effectiveness of treatment;<\/li>\n\n\n\n<li>the optimal dose;<\/li>\n\n\n\n<li>possible side effects.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Phase 3<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">These are the largest and most important clinical studies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hundreds or thousands of patients from different countries can participate.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Phase 3 aims to confirm:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>the effectiveness of therapy;<\/li>\n\n\n\n<li>long-term safety;<\/li>\n\n\n\n<li>benefits over existing treatments.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Many of the international studies conducted in Bulgaria are from this phase.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Regulatory approval<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Once clinical trials are completed, all data are submitted to regulatory authorities.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In Europe, this includes an estimate of:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">European Medicines Agency<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Experts analyze:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>the results of the studies;<\/li>\n\n\n\n<li>safety profile;<\/li>\n\n\n\n<li>quality of production.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Only if the benefits outweigh the risks does the drug receive a marketing authorisation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Phase 4 - after approval<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Even after a drug reaches the market, monitoring continues.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The so-called Phase 4 tracks:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>long-term safety;<\/li>\n\n\n\n<li>rare side effects;<\/li>\n\n\n\n<li>efficiency in real conditions.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This helps to continuously improve medical knowledge.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Why is the process so long<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Developing a new drug takes time because patient safety is a top priority.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Each stage is designed to answer important questions:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Does the treatment work?<\/li>\n\n\n\n<li>Is it safe?<\/li>\n\n\n\n<li>In which patients is it most effective?<\/li>\n\n\n\n<li>What are the potential risks?<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This rigorous process ensures that only therapies with proven qualities reach patients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The role of clinical trials<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Without clinical trials, the development of modern medicine would be impossible.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Thanks to them, today we have effective therapies for many diseases, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>oncological diseases;<\/li>\n\n\n\n<li>autoimmune diseases;<\/li>\n\n\n\n<li>dermatological diseases;<\/li>\n\n\n\n<li>rare diseases;<\/li>\n\n\n\n<li>cardiovascular disease.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">In addition, participants in clinical trials often gain access to innovative therapies years before they become widely available.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Developing a new drug is a long and complex process that can take more than a decade. From laboratory research to large international clinical trials, every step is aimed at ensuring the safety and effectiveness of future treatments.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is why clinical trials are among the most important drivers of medical progress and the hope for better therapies in the future.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u041a\u043e\u0433\u0430\u0442\u043e \u0447\u0443\u0435\u043c \u0437\u0430 \u043d\u043e\u0432\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u043e, \u0447\u0435\u0441\u0442\u043e \u0441\u0438 \u043f\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u044f\u043c\u0435, \u0447\u0435 \u0442\u043e \u0435 \u0440\u0435\u0437\u0443\u043b\u0442\u0430\u0442 \u043e\u0442 \u043d\u044f\u043a\u043e\u043b\u043a\u043e \u0433\u043e\u0434\u0438\u043d\u0438 \u0440\u0430\u0431\u043e\u0442\u0430 \u0432 \u043b\u0430\u0431\u043e\u0440\u0430\u0442\u043e\u0440\u0438\u044f. \u0412 \u0434\u0435\u0439\u0441\u0442\u0432\u0438\u0442\u0435\u043b\u043d\u043e\u0441\u0442 \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u0432\u0430\u043d\u0435\u0442\u043e \u043d\u0430 \u043d\u043e\u0432 \u043c\u0435\u0434\u0438\u043a\u0430\u043c\u0435\u043d\u0442 \u0435 \u0435\u0434\u0438\u043d \u043e\u0442 \u043d\u0430\u0439-\u0434\u044a\u043b\u0433\u0438\u0442\u0435 \u0438 \u0441\u043b\u043e\u0436\u043d\u0438 \u043f\u0440\u043e\u0446\u0435\u0441\u0438 \u0432 \u0441\u044a\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u0430\u0442\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0430. \u041e\u0442 \u043f\u044a\u0440\u0432\u043e\u043d\u0430\u0447\u0430\u043b\u043d\u0430\u0442\u0430 \u0438\u0434\u0435\u044f \u0434\u043e \u0434\u043e\u0441\u0442\u0438\u0433\u0430\u043d\u0435\u0442\u043e \u043d\u0430 \u043b\u0435\u0447\u0435\u043d\u0438\u0435\u0442\u043e \u0434\u043e \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u0438\u0442\u0435 \u043c\u043e\u0433\u0430\u0442 \u0434\u0430 \u0438\u0437\u043c\u0438\u043d\u0430\u0442 \u043c\u0435\u0436\u0434\u0443 10 \u0438 15 \u0433\u043e\u0434\u0438\u043d\u0438, \u0430 \u043f\u043e\u043d\u044f\u043a\u043e\u0433\u0430 \u0438 \u043f\u043e\u0432\u0435\u0447\u0435. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2378,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_seopress_titles_title":"\u041a\u043e\u043b\u043a\u043e \u0432\u0440\u0435\u043c\u0435 \u043e\u0442\u043d\u0435\u043c\u0430 \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u0432\u0430\u043d\u0435\u0442\u043e \u043d\u0430 \u043d\u043e\u0432\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u043e: \u043e\u0442 \u043b\u0430\u0431\u043e\u0440\u0430\u0442\u043e\u0440\u0438\u044f\u0442\u0430 \u0434\u043e \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u0430","_seopress_titles_desc":"\u041d\u0430\u0443\u0447\u0435\u0442\u0435 \u043a\u043e\u043b\u043a\u043e \u0432\u0440\u0435\u043c\u0435 \u043e\u0442\u043d\u0435\u043c\u0430 \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u0432\u0430\u043d\u0435\u0442\u043e \u043d\u0430 \u043d\u043e\u0432\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u043e \u0438 \u043a\u0430\u043a\u0432\u0430 \u0435 \u0440\u043e\u043b\u044f\u0442\u0430 \u043d\u0430 \u043a\u043b\u0438\u043d\u0438\u0447\u043d\u0438\u0442\u0435 \u043f\u0440\u043e\u0443\u0447\u0432\u0430\u043d\u0438\u044f \u0432 \u043f\u0440\u043e\u0446\u0435\u0441\u0430 \u043d\u0430 \u0434\u043e\u043a\u0430\u0437\u0432\u0430\u043d\u0435 \u043d\u0430 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442 \u0438 \u0435\u0444\u0435\u043a\u0442\u0438\u0432\u043d\u043e\u0441\u0442.","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"","_seopress_redirections_param":"","_seopress_redirections_type":0,"_seopress_analysis_target_kw":"","footnotes":""},"categories":[8],"tags":[],"class_list":["post-2377","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-klinichni-prouchvaniya"],"_links":{"self":[{"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/posts\/2377","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/comments?post=2377"}],"version-history":[{"count":0,"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/posts\/2377\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/media\/2378"}],"wp:attachment":[{"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/media?parent=2377"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/categories?post=2377"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/unimed.bg\/en\/wp-json\/wp\/v2\/tags?post=2377"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}