Establishing the Pharmacokinetics of Genetic Vaccines is Essential for Maximising their Safety and Efficacy

Author:

Naasani ImadORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference36 articles.

1. Remington: The Science and Practice of Pharmacy – 1 Jun. 2005 by David B. Troy (Editor)

2. WHO Technical Report Series, No. 927, 2005 Annex 1- WHO guidelines on nonclinical evaluation of vaccines https://www.who.int/publications/m/item/annex1-nonclinical.p31-63

3. Plitnick LM. Global Regulatory Guidelines for Vaccines. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. 2013;225-241. doi:https://doi.org/10.1016/B978-0-12-394810-6.00009-5

4. Guideline on Clinical Evaluation of New Vaccines EMEA/CHMP/VWP/164653/2005. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-new-vaccines_en.pdf.

5. Health Canada. Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application. June 2016. https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/drug/harmonized-requirements-licensing-vaccines-guidelines-preparation-application.html

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