{"id":7223,"date":"2024-02-12T10:00:03","date_gmt":"2024-02-12T08:00:03","guid":{"rendered":"https:\/\/eu.bd.com\/iv-news\/?p=7223"},"modified":"2024-03-07T14:15:50","modified_gmt":"2024-03-07T13:15:50","slug":"best-practices-for-phase-1-investigational-drugs-trials","status":"publish","type":"post","link":"https:\/\/eu.bd.com\/iv-news\/news-innovation\/best-practices-for-phase-1-investigational-drugs-trials\/","title":{"rendered":"Best practices for phase 1 investigational drugs trials"},"content":{"rendered":"

Before pharmaceutical products are released onto the market, they undergo extensive screening as an investigational drug (IND, or investigational new drug) to ensure the new molecule’s safety and adherence to regulations.1,2 <\/sup>In contrast to commercially available medications, the safe processing and dispensing of investigational drugs has not been widely standardised.3 <\/sup>Read on to discover the latest guidance on safe investigational drug manufacturing and administration.<\/p>\n

More on this topic: <\/span><\/b>New clinic study: Reduce hazardous drug contamination with BD<\/a><\/p>\n

Hazards involved with these kinds of drugs<\/h2>\n

Investigational drugs must follow current good manufacturing practices (CGMPs) when they reach phase 1 clinical trials, as this stage represents their first introduction to human subjects.2,4 <\/sup>However, there is still room for error: the Institute for Safe Medication Practices (ISMP) found potential for errors in naming practices, drug labels, packaging, product appearance, and expiration dating among study sponsors.3 <\/sup>As well, phase 1 investigational drugs are still new chemicals, meaning there is often little information on potential toxicity.5<\/sup><\/p>\n

According to Valdeolmillos et al, investigational drugs should be considered hazardous until they can be fully excluded, \u201cas it is not frequent to have hazard studies available or the information about safety is usually insufficient.\u201d6 <\/sup>Hazardous drug exposure, even in small concentrations, can cause adverse effects such as internal organ damage, genetic mutations, cancer and higher rates of reproductive issues.7-12<\/sup><\/p>\n

More on this topic: <\/span><\/b>Make the safety switch: 4 potential everyday safety hazards<\/a><\/p>\n

Safety in phase 1 clinical trials of investigational drugs<\/h2>\n

The United States Food & Drug Administration’s CGMPs for phase 1 investigational drugs include rigorous written instructions for safe receipt, handling, storage, dispensing, retrieval and return of the drug during trials.13 <\/sup>The European Directive 2001\/83\/EC<\/a>, which outlines the requirements for medicinal products intended for human use, requires an extensive written summary of product characteristics as well.2<\/sup><\/p>\n

As with all hazardous drugs, the US CGMPs also state that the use of closed-system transfer devices, ensuring that the investigational drug is not exposed to the environment during processing, can alleviate the need for stricter room classification for air quality.4 <\/sup>Studies show that the use of closed-system transfer devices may help reduce hazardous drug contamination.7 <\/sup>The European CGMPs mention that special attention should be paid to ensure safe handling of investigational drugs to avoid cross contamination, identifying the importance of establishing a sufficient quality control system.14<\/sup><\/p>\n","protected":false},"excerpt":{"rendered":"

Before pharmaceutical products are released onto the market, they undergo extensive screening as an investigational drug (IND, or investigational new…<\/p>\n","protected":false},"author":8,"featured_media":7228,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7223","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-innovation","speciality-drug-compounding","speciality-healthcare-worker-safety","speciality-infection-prevention","speciality-patient-safety","contenttype-article","target-clinical-pharmacy","target-doctor","target-hospital-director-manager","target-infection-prevention","target-nursing","target-procurement"],"acf":[],"yoast_head":"\nBest practices for phase 1 investigational drugs trials - BD IV News<\/title>\n<meta name=\"description\" content=\"Learn more about the safe handling and manufacturing of investigational drugs to ensure healthcare worker and patient safety.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eu.bd.com\/iv-news\/news-innovation\/best-practices-for-phase-1-investigational-drugs-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Best practices for phase 1 investigational drugs trials - 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