How do we determine the low dose in reproductive toxicity tests

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. 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. Medicilon’s Pharmacology & Toxicology Study We boast professional teams and practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research can be carried out according to non-GLP or GLP standards. Our research platform has been rated as Shanghai R&D Public Service Platform.