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Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics.
Davda, Jasmine; Reynolds, Kellie; Davis, John D; Smith, Patrick F.
  • Davda J; Certara, Princeton, NJ, USA.
  • Reynolds K; Division of Infectious Disease Pharmacology (DIDP), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Davis JD; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
  • Smith PF; Certara, Princeton, NJ, USA.
Br J Clin Pharmacol ; 87(9): 3398-3407, 2021 09.
Article in English | MEDLINE | ID: covidwho-1186136
ABSTRACT
Perhaps the most important lesson learned from the COVID-19 pandemic is that of preparedness. Enhanced surveillance systems for early threat detection will be crucial to maximizing response time for implementation of public health measures and mobilization of resources in containing an emerging pandemic. Recent outbreaks have been dominated by viral pathogens, with RNA respiratory viruses being the most likely to have pandemic potential. These should therefore be a preparedness priority. Tools in the areas of virology, drug discovery, clinical pharmacology, translational medicine and pharmacometrics should be considered key components in the rapid identification and development of existing and novel interventions for a pandemic response. Prioritization of therapeutics should be based on in vitro activity, likelihood of achieving effective drug concentrations at the site of action, and safety profile at the doses that will be required for clinical efficacy. Deployment strategies must be tailored to the epidemiology of the disease, and the adequacy of the response should be re-evaluated in view of evolving epidemiological factors. An interdisciplinary framework integrating drug pharmacology, viral kinetics, epidemiology and health economics could help optimize the deployment strategy by improving decision-making around who to treat, when to treat, and with what type of intervention for optimal outcomes. Lastly, while an effective vaccine will ultimately end a pandemic, antiviral drug intervention guided by clinical pharmacology principles will continue to play a critical role in any pandemic response.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pharmacology, Clinical / COVID-19 Type of study: Experimental Studies / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Br J Clin Pharmacol Year: 2021 Document Type: Article Affiliation country: Bcp.14859

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pharmacology, Clinical / COVID-19 Type of study: Experimental Studies / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Br J Clin Pharmacol Year: 2021 Document Type: Article Affiliation country: Bcp.14859