Bioequivalence and Bioavailability Forum

Dear Ms Silvia Giarcovich,

» (always with a nurse at all times and a medical doctor visiting all the volunteers, etc etc)?

It is highly advisable to keep the volunteers under the medical supervision of physicians for a specified period after administration of investigational product. Also, in case of any emergency, housing the subjects in their home is not practically safe to manage any serious adverse events.

» One possibility would be to include a PCR / COVID-19 test both at screening and before each administration period and at the end of the study.

Yes. We can include negative RT-PCR as one of the subject's inclusion criteria during screening/each check-in/post study evaluation in the protocol itself to minimize the risk of infection/transmission of Coronavirus during the housing period.