How do we determine the low dose in reproductive toxicity tests?
- 7个月前
For the low-dose tests， we are looking for a dose point that does not prove any adverse reactions in reproductive toxicity tests NOAEL. In doing so, we need to consider the exposure dose, pharmacology features, and toxicity and establish the proper dose-reaction relationship.
https://www.medicilon.com/videos/low-dose-in-reproductive-toxicity/
In most cases, we set three doses for small molecule drugs and biotechnology therapies and two doses for vaccines to observe their reproductive toxicity.
We'd suggest setting the low dose at 1-5 times the MRHD exposure dose.
We also need to prove the rationality of our dose design if we decide to set the low dose at the level of the sub-therapeutic amounts.
https://www.medicilon.com/videos/low-dose-in-reproductive-toxicity/
In most cases, we set three doses for small molecule drugs and biotechnology therapies and two doses for vaccines to observe their reproductive toxicity.
We'd suggest setting the low dose at 1-5 times the MRHD exposure dose.
We also need to prove the rationality of our dose design if we decide to set the low dose at the level of the sub-therapeutic amounts.