Selvita (Fidelta)

Selvita (Fidelta)A European CRO offering comprehensive support from drug discovery research to non-clinical developmentIt is. We offer contract research services including in vitro and in vivo pharmacology, DMPK, toxicology, and biomarker testing at our research facilities in Poland and Croatia, including the former Fidelta sites.

Features of Selvita's (Fidelta) preclinical contract research services

Evaluate candidate compounds in over 80 disease models

At Selvita,Over 80 validated rodent and rabbit modelsWe support in vivo pharmacological studies using . We cover a wide range of disease areas, including tumors, infectious diseases, inflammation, respiratory, digestive, fibrosis, metabolism, neurology, and immunology. Evaluations can be tailored to the development stage of candidate compounds, such as Proof-of-Concept, efficacy, PK/PD, Target Validation, and mechanism of action studies. In addition to existing models,Development of custom models tailored to the mechanism of action of compounds and research objectivesIt also supports this, allowing research plans to be developed even for candidate substances that are difficult to evaluate using standard testing systems.

non-clinical evaluation combining toxicity and pharmacokinetics

Integrating in vivo pharmacology, toxicology, histopathology, and DMPKis also a characteristic of Selvita's (Fidelta) preclinical studies. In toxicity studies, mice, rats, and rabbits are used to conduct single and repeat-dose toxicity, tolerability, maximum tolerated dose, and dose-ranging studies. Toxicity evaluations can combine toxicokinetics, clinical pathology, and histopathology. Because it is possible to evaluate not only drug efficacy, but also systemic effects and tissue-level changes after administration,If you would like to evaluate the efficacy and safety of candidate compounds in parallelcan also be used for. Please note that the official website currently offers toxicity servicesnon-GLPAs we are providing guidance as such, if a GLP toxicity study is required, individual confirmation is necessary.

Integrating PK/PD and biomarkers to support development

In in vivo PK,Pharmacokinetic studies using mice and ratsand conduct single and repeated dose studies, bioavailability, excretion, and tissue/CSF sampling. PK/PD data can also be combined with modeling and simulation. In addition, biomarker analysis utilizing qPCR, ELISA, flow cytometry, mass spectrometry, etc., is available.Multi-faceted evaluation of candidate compound effects by combining pharmacokinetic, pharmacodynamic, and biomarker dataYes, we can. We also offer bioanalytical services compliant with GLP/GMP, and our key feature is the ability to build a seamless research framework ranging from early-stage drug discovery research to developmental evaluations.

An example of disease models owned by Selvita (Fidelta)

At Selvita,Models of inflammatory and respiratory diseases such as pulmonary fibrosis and asthmaWe support drug efficacy evaluations using . For example, in pulmonary fibrosis, non-invasive evaluation using Micro-CT is also possible. By combining image-based longitudinal observation with drug efficacy evaluation, changes in lung condition due to treatment can be continuously monitored. In addition to using existing models, we also accommodate the development of new models tailored to specific research objectives.

Nonclinical study cases of Selvita (Fidelta)

Search for lead compounds as candidate drugs for asthma

Fidelta, the predecessor of Selvita, from a major European pharmaceutical companyLead compound discovery targeting asthma, especially severe asthmaWe have a proven track record of being contracted for projects. Over a period of approximately 12 months, we conducted research combining medicinal chemistry, in vitro and in vivo pharmacology, DMPK, and pharmaceutical sciences, with a view toward future safety evaluation and candidate compound selection. By coordinating multiple specialized areas, this is an example of comprehensively supporting the process from the discovery of candidate compounds to the narrowing down of development candidates.

Company Information for Selvita (Fidelta)