AI Article Synopsis
- The approval process for clinical trials mandates detailed quality documentation of new drugs used on participants.
- In the EU, this documentation is compiled into an investigational medicinal product dossier (IMPD), while in the US, it's known as an investigational new drug (IND) application.
- Compliance with production and quality assurance standards is essential, with particular emphasis on requirements for mRNA vaccines following European guidelines.
Article Abstract
The approval of clinical trials by the competent authorities requires comprehensive quality documentation on the new drug to be used on the clinical trial participant. In the EU, quality data is summarized as investigational medicinal product dossier (IMPD), in the United States, as investigational new drug (IND) application. For that, several preconditions concerning production, quality control, and assurance have to be fulfilled. Here, specific requirements related to mRNA vaccines are addressed on the basis of European standards.
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| http://dx.doi.org/10.1007/978-1-0716-3770-8_15 | DOI Listing |
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