TriApex provides developmental and reproductive toxicology (DART) studies of the development of new chemical entities (NCEs) and biologics. TriApex can conduct different stages of DART studies according to the proposed indication, product characteristics, and phase of pharmaceutical development.
1. TriApex is staffed by a professional and experienced DART research team, and capable to conduct DART studies in rodents and non-rodents (rabbit, monkey).
2. We provide scientific study design and customized services according to the proposed indication, product characteristics, and phase of pharmaceutical development.
1. Fertility and early embryonic developmental (FEED) study (rodents)
2. Embryo-fetal developmental (EFD) toxicity study (rodents and non-rodents)
3. Pre- and postnatal development (PPND) toxicity study (rodents)
4. Enhanced pre- and postnatal development (ePPND) toxicity study (NHPs)
5. Combination studies
The aim of DART studies is to reveal any effect of the pharmaceutical on mammalian reproduction relevant for human risk evaluation to provide reference for clinical reproductive risk assessment. As appropriate, the set of studies conducted should encompass observations through one complete life cycle (i.e., from conception in one generation through conception in the following generation), and permit detection of immediate and latent adverse effects. To support clinical development, FEED, EFD in two species, and PPND studies are commonly required.
TriApex has designed multiple staged or combination reproductive toxicology studies for sponsors based on the product characteristics and proposed indication to accelerate clinical trials or marketing process.
We conducted GLP-compliant FEED, EFD and PPND studies of one mRNA vaccine to support the IND submissions according to the product characteristics and relevant guidelines, and worked with the sponsor to successfully push forward the phase I, II and III clinical trials of this product.