Additional Posts in Life Sciences Consulting
Can anyone relate?

Additional Posts (overall)
Anyone work w RegDev?
New to Fishbowl?
Download the Fishbowl app to
unlock all discussions on Fishbowl.
unlock all discussions on Fishbowl.
Can anyone relate?
Anyone work w RegDev?
Send download link to your phone
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Download the Fishbowl app to unlock all discussions on Fishbowl.
Copy and paste embed code on your site
Yes this is an efficacy endpoint known as DoR (duration of response) - most often used in oncology alongside ORR and CR/PR/SD/PD.
If you’re talking preclinical - you’re looking at PK T1/2, tumor inhibition % and duration of PD response.
Mentor
Listen to D1. He/she knows their shit.
OP I think you are looking to understand pk/pd
Durability? So like half life?
Pkpd would be a related way of measuring this, though it doesn’t necessarily translate to what you’re trying to get at I think.
Robustness is an awkward word to use here I think. I think you're referring to stability which is related to shelf life or PK/PD which is related to frequency of administration. Both dependent on a lot of factors.
I saw a clinical trial use "durability of response" as a secondary endpoint a while ago. It was a biologic but I could see it making sense for small molecules
Durability is more of a long term efficacy question - sure we saw a 30% reduction in primary outcome for 18 months in clinical studies, but is that reduction maintained at the 3 years? 5 years? Etc. Real world evidence has entered the chat