دورية أكاديمية
Regulatory Considerations for Producing mRNA Vaccines for Clinical Trials.
| العنوان: | Regulatory Considerations for Producing mRNA Vaccines for Clinical Trials. |
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| المؤلفون: | Schmid A; Albstadt-Sigmaringen University, Sigmaringen, Germany. schmida@hs-albsig.de. |
| المصدر: | Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2024; Vol. 2786, pp. 321-337. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Humana Press Country of Publication: United States NLM ID: 9214969 Publication Model: Print Cited Medium: Internet ISSN: 1940-6029 (Electronic) Linking ISSN: 10643745 NLM ISO Abbreviation: Methods Mol Biol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Totowa, NJ : Humana Press Original Publication: Clifton, N.J. : Humana Press, |
| مواضيع طبية MeSH: | Clinical Trials as Topic* , mRNA Vaccines* , Quality Control*, Humans ; RNA, Messenger/genetics ; United States ; Investigational New Drug Application ; Vaccines, Synthetic |
| مستخلص: | 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. (© 2024. The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature.) |
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| فهرسة مساهمة: | Keywords: Active substance; Clinical trial; IMPD; LNP; Specification; mRNA; Investigational medicinal product |
| المشرفين على المادة: | 0 (mRNA Vaccines) 0 (RNA, Messenger) 0 (Vaccines, Synthetic) |
| تواريخ الأحداث: | Date Created: 20240530 Date Completed: 20240530 Latest Revision: 20240530 |
| رمز التحديث: | 20240530 |
| DOI: | 10.1007/978-1-0716-3770-8_15 |
| PMID: | 38814402 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1940-6029 |
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| DOI: | 10.1007/978-1-0716-3770-8_15 |