{"id":3188,"date":"2024-06-10T11:22:33","date_gmt":"2024-06-10T15:22:33","guid":{"rendered":"https:\/\/cytel.agencyukdev.com\/perspectives\/guidelines-are-not-instruction-manuals-customize-your-way-to-first-in-human-clinical-trials\/"},"modified":"2024-08-22T05:33:41","modified_gmt":"2024-08-22T09:33:41","slug":"guidelines-are-not-instruction-manuals-customize-your-way-to-first-in-human-clinical-trials","status":"publish","type":"perspectives","link":"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/guidelines-are-not-instruction-manuals-customize-your-way-to-first-in-human-clinical-trials\/","title":{"rendered":"Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials"},"content":{"rendered":"

Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are helpful, they should not be read like instruction manuals that can be applied the same way to every project. It is even possible that certain guidelines do not apply to your project at all! Therefore, guidelines need to be customized to fit your unique project. Before diving headfirst into the guidelines, read on for tips to help you understand the essential regulatory requirements leading up to first-in-human clinical trials.<\/p>\n

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Essential regulatory requirements before first-in-human clinical trials<\/h2>\n

First-in-human clinical trials are performed to study the safety and tolerability of an investigational medicinal product. This will lay the foundation for all forthcoming clinical evaluations. The main priority is to ensure the safety for trial participants, and all preceding development work aims to characterize and minimize risks in accordance with regulatory guidelines.<\/p>\n

Again, each drug product is unique. Therefore, parts of the guidelines are applicable to some drug products and not to others. Everything does not apply to every product.<\/p>\n

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Chemical and pharmaceutical quality \u2014 Always important but often overlooked<\/h2>\n

During development, quality demands may differ from study to study. However, your drug substance and product must always be adequately characterized when it comes to purity, stability, and manufacturing processes. If not, patient safety could be compromised. As a result, regulatory authorities will have no confidence in the results obtained throughout the drug development process.<\/p>\n

Establishing a thorough understanding of your molecule and drug product is critical. Not doing so is a common reason for increased costs and time delays in your project.<\/p>\n

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Nonclinical studies \u2014 Understanding your drug and its safety is crucial<\/h2>\n

Nonclinical studies should support a safe starting dose in humans and identify safety parameters for clinical monitoring. For any new drug product, it is therefore necessary to characterize:<\/p>\n