{"id":24501,"date":"2022-05-30T10:00:29","date_gmt":"2022-05-30T09:00:29","guid":{"rendered":"https:\/\/ppr-antibioresistance.inserm.fr\/?p=24501"},"modified":"2022-05-30T10:00:33","modified_gmt":"2022-05-30T09:00:33","slug":"evaluation-of-medicinal-products-indicated-for-treatment-of-bacterial-infections","status":"publish","type":"post","link":"https:\/\/ppr-antibioresistance.inserm.fr\/en\/informations-et-communications\/bilans-rapports-et-recommandations\/evaluation-of-medicinal-products-indicated-for-treatment-of-bacterial-infections\/","title":{"rendered":"Evaluation of medicinal products indicated for treatment of bacterial infections"},"content":{"rendered":"\n<p>Article published on the <a href=\"https:\/\/www.ema.europa.eu\/en\/evaluation-medicinal-products-indicated-treatment-bacterial-infections\" target=\"_blank\" rel=\"noreferrer noopener\">European Medicines Agency<\/a> on May 19, 2022<\/p>\n\n\n\n<p>This\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/guideline\" target=\"_blank\" rel=\"noreferrer noopener\">guideline<\/a>\u00a0merges, revises and adds to the guidance previously included in the\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/guideline\" target=\"_blank\" rel=\"noreferrer noopener\">Guideline<\/a>\u00a0on the evaluation of\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/medicinal-product\" target=\"_blank\" rel=\"noreferrer noopener\">medicinal products<\/a>\u00a0indicated for treatment of bacterial infections (CPMP\/EWP\/558\/95 Rev 2) and the\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address\" target=\"_blank\" rel=\"noreferrer noopener\">Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections<\/a>\u00a0(EMA\/<a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a>\/351889\/2013).<\/p>\n\n\n\n<p><strong>Keywords:<\/strong>&nbsp;Non-inferiority studies, superiority studies, susceptibility testing, pharmacokinetic \/ pharmacodynamic (PK\/PD) relationship, bacteraemia, febrile neutropenia, eradication of carriage, drug-resistant organisms;&nbsp;<a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/paediatric-investigation-plan\" target=\"_blank\" rel=\"noreferrer noopener\">paediatric investigation plan<\/a>&nbsp;(PIP)<a><\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Table of contents<\/h3>\n\n\n\n<ul><li><a href=\"https:\/\/www.ema.europa.eu\/en\/evaluation-medicinal-products-indicated-treatment-bacterial-infections#current-version-section\" target=\"_blank\" rel=\"noreferrer noopener\">Current version<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/evaluation-medicinal-products-indicated-treatment-bacterial-infections#document-history-section\" target=\"_blank\" rel=\"noreferrer noopener\">Document history<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/evaluation-medicinal-products-indicated-treatment-bacterial-infections#related-content-section\" target=\"_blank\" rel=\"noreferrer noopener\">Related content<\/a><\/li><\/ul>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Article published on the European Medicines Agency on May 19, 2022 This\u00a0guideline\u00a0merges, revises and adds to the guidance previously included in the\u00a0Guideline\u00a0on the evaluation of\u00a0medicinal products\u00a0indicated for treatment of bacterial infections (CPMP\/EWP\/558\/95 Rev 2) and the\u00a0Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections\u00a0(EMA\/CHMP\/351889\/2013). Keywords:&nbsp;Non-inferiority studies, superiority studies, [&hellip;]<\/p>\n","protected":false},"author":139,"featured_media":24519,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[37],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Evaluation of medicinal products indicated for treatment of bacterial infections - French\u00a0National ANTIBIOTIC RESISTANCE Portal<\/title>\n<meta name=\"description\" content=\"Informations, \u00e9v\u00e8nements et actualit\u00e9s autour de l&#039;Antibior\u00e9sistance en France et \u00e0 l&#039;international.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ppr-antibioresistance.inserm.fr\/en\/informations-et-communications\/bilans-rapports-et-recommandations\/evaluation-of-medicinal-products-indicated-for-treatment-of-bacterial-infections\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Evaluation of medicinal products indicated for treatment of bacterial infections - 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