Non-human primates Services
According to ICHM3 guideline requirements, for New Chemical Entities (NCE) repeat-dose toxicity studies in two species (one rodent and one nonrodent), are expected to support administration of more than a single dose of pharmaceuticals in humans. Dogs and minipigs are the usual non-rodents species in most cases. Nevertheless, NHP can be selected as the non-rodent species to characterize toxicity for those compounds which show a significantly different metabolic profile respect to humans in the usual non-rodent species or in those cases when these species show unique sensitivity to the NCE.
In the case of biopharmaceuticals, ICHS6 guideline establish the need of defining the toxicological properties of the drug in question prior to human exposure in at least on pharmacologically relevant species, understood as “one in which the test material is pharmacologically active due to the expression of the receptor or an epitope (in the case of monoclonal antibodies).” In this scenario, NHP is a very valuable animal model, given the phylogenetic closeness and particular similarities in metabolism, sensory organs, hormonal system, reproduction and immune system.
Vivotecnia offers the following NHP studies:
- Safety pharmacology studies.
- Toxicological research.
- Pharmacokinetics and Toxicokinetics research.
These studies can be conducted via common routes and via other techniques that are more compound specific:
- Oral: Gavage, Capsules, Pills
- Intra-vaginal and Intra-urethral
Maybe you are interested in…
PK/PD and Metabolism
Over the drug discovery process, ADME (Absorption, Distribution, Metabolism, and Elimination) and PK studies are deemed necessary to evaluate the bioavailability…
Inhalation toxicity studies are required to assess the exposure hazards for consumer products or manufacturing workers.
Our team of experienced, highly-educated scientists, with backgrounds in toxicology, molecular biology, chemistry and immunology, understand that the drug development process is no longer a one-size fits all approach.
Safety Pharmacology satisfies a key requirement in the process of a drug development, assessing the potential adverse effects of drug candidates on the major physiological systems of the body.
Non-human primate unit: a second non-rodent species alternative