6 ms·

What’s the process for this to be tested and moved onwards toward approved use?

epistasis 3y ago
Phase 1: basic safety, some amount of dose-finding. Small number of patients. Phase 2: does it appear to work as intended, tested in a larger number of people Phase 3: is it better than alternatives. Then approval, followed by monitoring of the drug and side effects. There's also an additional phase of getting insurance to pay for the new drug, which can be the most difficult. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html https://www.cancer.org/cancer/managing-cancer/making-treatme...
- anotherboffin 3y ago
  Nice summary! From my limited knowledge in case someone’s more interested. Don’t know if it’s different in oncology. Phase 1 is pretty big on safety: sentinel dosing, then gradually increasing doses until the established max is reached or until serious side effects show up. Generally also includes PK/PD aspects: what is the half-life, how long it’s detectable in the body, does this match the modeling? How is the drug eliminated? All this is used to refine the dosing (if need be) but also provides a lot of the information needed for the safety documentation.
piyh 3y ago
Phase 1 trial scheduled to end in March 2024 https://classic.clinicaltrials.gov/ct2/show/NCT05227326 https://classic.clinicaltrials.gov/ct2/show/NCT05227326
jokowueu 3y ago
Tbh Since it's a small molecule you can just hire a lab to make a custom synth , I've seen it done a few times,
- syntaxing 3y ago
  So…what kind of labs can you hire to make this and how much would it cost?
  - deleted 3y ago
    [deleted]
  - jokowueu 3y ago
    It depends on the difficulty of making it and the amount required. https://pastebin.com/0pyuDBX1 https://pastebin.com/0pyuDBX1
- anotherboffin 3y ago
  Formulation is pretty important too. Do they give any detail on that?

Phase 1: basic safety, some amount of dose-finding. Small number of patients. Phase 2: does it appear to work as intended, tested in a larger number of people Phase 3: is it better than alternatives. Then approval, followed by monitoring of the drug and side effects. There's also an additional phase of getting insurance to pay for the new drug, which can be the most difficult. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html https://www.cancer.org/cancer/managing-cancer/making-treatme...

anotherboffin 3y ago
Nice summary! From my limited knowledge in case someone’s more interested. Don’t know if it’s different in oncology. Phase 1 is pretty big on safety: sentinel dosing, then gradually increasing doses until the established max is reached or until serious side effects show up. Generally also includes PK/PD aspects: what is the half-life, how long it’s detectable in the body, does this match the modeling? How is the drug eliminated? All this is used to refine the dosing (if need be) but also provides a lot of the information needed for the safety documentation.

piyh 3y ago

Phase 1 trial scheduled to end in March 2024 https://classic.clinicaltrials.gov/ct2/show/NCT05227326 https://classic.clinicaltrials.gov/ct2/show/NCT05227326

jokowueu 3y ago

Tbh Since it's a small molecule you can just hire a lab to make a custom synth , I've seen it done a few times,

syntaxing 3y ago
So…what kind of labs can you hire to make this and how much would it cost?
- deleted 3y ago
  [deleted]
- jokowueu 3y ago
  It depends on the difficulty of making it and the amount required. https://pastebin.com/0pyuDBX1 https://pastebin.com/0pyuDBX1
anotherboffin 3y ago
Formulation is pretty important too. Do they give any detail on that?