RNA Vaccines
Springer New York
Chapter title |
Considerations for Producing mRNA Vaccines for Clinical Trials.
|
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Chapter number | 15 |
Book title |
RNA Vaccines
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Published in |
Methods in molecular biology, January 2017
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DOI | 10.1007/978-1-4939-6481-9_15 |
Pubmed ID | |
Book ISBNs |
978-1-4939-6479-6, 978-1-4939-6481-9
|
Authors |
Andreas Schmid, Schmid, Andreas |
Editors |
Thomas Kramps, Knut Elbers |
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 USA 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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Germany | 2 | 15% |
Australia | 1 | 8% |
Unknown | 10 | 77% |
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Members of the public | 12 | 92% |
Scientists | 1 | 8% |
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Unknown | 41 | 100% |
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Researcher | 6 | 15% |
Student > Ph. D. Student | 5 | 12% |
Student > Bachelor | 4 | 10% |
Other | 3 | 7% |
Student > Master | 2 | 5% |
Other | 3 | 7% |
Unknown | 18 | 44% |
Readers by discipline | Count | As % |
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Biochemistry, Genetics and Molecular Biology | 6 | 15% |
Medicine and Dentistry | 3 | 7% |
Agricultural and Biological Sciences | 2 | 5% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 5% |
Materials Science | 2 | 5% |
Other | 6 | 15% |
Unknown | 20 | 49% |