Regulation of Geroprotective Medications

Author:

Stambler Ilia

Publisher

Springer International Publishing

Reference19 articles.

1. EMA. European Medicines Agency (2018) Medicines for older people. London. https://www.ema.europa.eu/en/human-regulatory/research-development/medicines-older-people. Accessed 15 Feb 2019

2. FDA. US Department of Health and Human Services Food and Drug Administration (2012) Guidance for industry. E7 studies in support of special populations: geriatrics. Questions and answers. Food and Drug Administration, Silver Spring. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm189544.pdf. Accessed 15 Feb 2019

3. Gurwitz JH, Goldberg RJ (2011) Age-based exclusions from cardiovascular clinical trials: implications for elderly individuals (and for all of us). Comment on “the persistent exclusion of older patients from ongoing clinical trials regarding heart failure”. Arch Intern Med 171:557–558. https://doi.org/10.1001/archinternmed.2011.33

4. Hall SS (2015) A trial for the ages. Science 349:1275–1278. https://doi.org/10.1126/science.349.6254.1274

5. ICH. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1993) ICH harmonized tripartite guideline E7, Studies in support of special populations: geriatrics. ICH, Brussels

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