Nonclinical Toxicology
Genotoxicity assessment is an integral part of preclinical safety studies required by regulatory agencies such as EMA, FDA, ICH, and OECD. These studies are mandatory for the registration of pharmaceutical products, industrial chemicals, crop protection products, cosmetic agents, and food additives, and are used for both internal development decisions and formal regulatory processes.
Preclinical regulatory CRO
Established – 2000
At Vivotecnia all our studies are performed under GLP (Good Laboratory Practices) and following the corresponding OECD Guidelines. In addition, we strictly follow the ICH M3(R2) and ICH S2(R1) guidelines for genotoxicity testing, which provide a framework for performing genotoxicity testing during preclinical development of new pharmaceutical products. By adhering to these standards, we ensure that your compounds are tested properly and that your data are credible and reliable.
Genotoxicity Testing
At Vivotecnia, we perform a standardized battery of in vitro and in vivo assays aimed at detecting three main types of genetic damage:
The bacterial reverse mutation test (OECD TG 471) detects mutagens capable of inducing point mutations in bacteria (Salmonella typhimurium and Escherichia coli), both in the presence and absence of metabolic activation (S9). This in vitro test is widely used by researchers because of its high sensitivity and strong predictive value for carcinogenicity.
This test (OECD TG 473) is based on the analysis of cultured mammalian cells to identify structural chromosomal aberrations. It evaluates the clastogenic potential of a substance by observing alterations in metaphase and is a key component of the in vitro study package required before progressing to in vivo testing.
The in vivo micronucleus test (OECD TG 474) detects chromosomal and aneugenic damage in erythroid cells from bone marrow or peripheral blood in rodents. It allows the evaluation of the genotoxic potential of a substance in a whole organism and is particularly useful to confirm or refute results obtained in in vitro studies.
If you are looking for a committed team,
with experience and scientific vision,
Vivotecnia is your ally in preclinical
toxicology.
