General Questions
- Waves of COVID-19?
Will there be another wave of COVID-19?
- Convalescent plasma to treat COVID-19?
Can plasma from recovered COVID-19 patients treat other patients with COVID-19? FDA guidance on investigational COVID-19 convalescent plasma https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-covid-19-convalescent-plasma EC…
- Viral dose
Does a high viral dose worsen COVID-19?
- Waves of COVID-19?
Q&A from Webinar: Model-informed Drug Repurposing – Applications for COVID-19 (May 14)
- Adverse effect of ivermectin?
What about the adverse effect of IVM in deficit of p-glycoprotein expression?
- Simulate dosage forms?
Isn’t it possible as well to simulate dosage forms that can concentrate/or better target drug delivery to concentrate potential repurposed…
- Impact of polymorphism?
How is genetic polymorphism likely to impact these derived models? If the impact is significant, can genetic differences be incorporated…
Please share your questions from the webinar here. We will also post Q&A from the session. Thank you.
- Adverse effect of ivermectin?
Therapeutics for COVID-19
- Therapeutic levels for Hydroxychloroquine
The simulations presented at the webinar was for preventing COVID-19-infection. Do you expect target levels for HCQ to be higher…
- Heparin
Can heparin prevent the viral entry of SARS-COV-2 and if so, what specific sulfation pattern is required?
- Combination treatment for COVID-19
Which drug combinations show the greatest promise for treating COVID-19? Do we have a sense of the dose and timing…
- Therapeutic levels for Hydroxychloroquine
Dosing for Special Patient Populations
- Pregnant Women
A small study out of China seems to indicate that pregnant women with COVID-19 could pass it on to their…
- Elderly Patients
The death rate for COVID-19 increases significantly at 50+ years of age. It is currently reported as 14.8% for patients…
- ICU and Critical Care Patients
On March 28th, Intensive Care Magazine published guidance on how to manage critically ill adults with COVID-19, and it includes…
There are important factors to consider when optimizing dosing of therapeutics for special patient populations such as the elderly, pregnant women, those in critical care, and children.
- Pregnant Women
Regulatory Considerations
- Clinical investigation timelines and approval process
What can be done by the regulators (FDA, EMA) to accelerate clinical investigation timelines and approval process for COVID-19 treatments?…
- IND Requirements for COVID-19
What CMC and nonclinical data is required to submit an IND for this indication?
- EMA provides recommendations on compassionate use of remdesivir
On April 3, 2020, the EMA provided recommendations on compassionate use of remdesivir for COVID-19 patients who are not eligible…
- Clinical investigation timelines and approval process
Vaccines for COVID-19
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- mRNA-1273
mRNA-1273 is a vaccine candidate developed by Moderna and the National Institute of Allergy and Infectious Disease (NIAID) Vaccine Research…
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In Silico Workbench
- Introduction to In Silico Workbench
The in silico workbench applications on this site are an ongoing work-in-progress which will be updated when more data is…
- Introduction to In Silico Workbench