While FreeThink Technologies is proud ASAP technology was helpful in getting regulatory approval of Paxlovid as a treatment for COVID-19, FreeThink was not involved in any way in Pfizer’s tremendous efforts to quickly bring this important drug to market. ASAP, as a method of determining drug stability, is playing an ever-increasing role in more rapidly bringing drugs to market, with this being a good example.
The US Food and Drug Administration has acknowledged Accelerated Stability Assessment Program (ASAP) studies as a primary stability justification for authorizing Paxlovid, Pfizer’s COVID-19 treatment tablet approved last year for emergency use.
Here’s what Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, had to say about the authorization in December:
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic. This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
FreeThink produces ASAPprime® software and is a leading provider of ASAP contract studies.
You can read the FDA’s review of Paxlovid on their website here (see page 61).