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Nonclinical Safety Testing of RNA Vaccines

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RNA Vaccines

Part of the book series: Methods in Molecular Biology ((MIMB,volume 1499))

Abstract

In this chapter, we first consider the overall goal of nonclinical safety testing during drug development and have a brief overview of its regulatory background. We then discuss some basic requirements of safety/toxicity testing before concentrating on the safety testing of RNA vaccines and developing a sample RNA vaccine safety testing program.

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References

  1. ICH M3(R2) Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, p 2. http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html. Accessed 29 Oct 2015

  2. Hager GH (2011) A checklist of some general basic requirements for starting toxicity studies of a New Chemical Entity (NCE). In: Company folder preclinical safety testing. Aurigon Life Science GmbH, Munchen

    Google Scholar 

  3. Hager GH (2011) A checklist of some general basic requirements for starting toxicity studies for New Biological Entities (NBE). In: Company folder preclinical safety testing. Aurigon Life Science GmbH, Munchen

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  4. Aurigon Life Science GmbH (2010) Sample study plan. Aurigon Life Science GmbH, Munchen

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  5. Aurigon Life Science GmbH (2010) Sample study report. Aurigon Life Science GmbH, Munchen

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  6. World Health Organization: Annex 1 who guidelines on nonclinical evaluation of vaccines, p 9. http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/en/. Accessed 29 Oct 2015

  7. European Medicines Agency EMA: guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products (EMEA/CHMP/GTWP/125459/2006). http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000410.jsp&mid=WC0b01ac058002958d. Accessed 29 Oct 2015

  8. World Health Organization: Annex 1 WHO guidelines on nonclinical evaluation of vaccines, pp 10–11. http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/en/. Accessed 29 Oct 2015

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Acknowledgements

The author thanks Helga Bleuel for her helpful comments during the preparation of this chapter.

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Correspondence to Gundel Hager .

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Hager, G. (2017). Nonclinical Safety Testing of RNA Vaccines. In: Kramps, T., Elbers, K. (eds) RNA Vaccines. Methods in Molecular Biology, vol 1499. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-6481-9_16

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  • DOI: https://doi.org/10.1007/978-1-4939-6481-9_16

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-6479-6

  • Online ISBN: 978-1-4939-6481-9

  • eBook Packages: Springer Protocols

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