InnoSer - Preclinical Development Services
From Drug Development
With the most promising lead compounds selected and optimized, preclinical research provides a final characterization and safety assessment of a potential candidate prior to dosing in humans. To prepare for a First-in-Human trial (FiH), a comprehensive dossier of preclinical findings needs to be filed and approved by the regulatory authorities to allow for clinical use as an investigational new drug (IND).
The IND-dossier requires an in-depth profiling and extrapolation of pharmacological parameters to substantiate the proposed clinical dosing-regimen to meet the requirements for the desired exposure in a human subject while minimizing its toxic effects.
It is part of InnoSer’s ambition to serve its customers in all stages of their preclinical research. As such, we are currently in the process of applying for a GLP-accreditation.
The InnoSer team applies a tailored approach towards the pharmacology and toxicology aspects of your research and adjust the study design on a case-by-case basis.
With our wide portfolio of methods and models, we can determine the transferability and reliability of your results supporting you in the transition of your compounds from bench to the clinic. Our team and network of experts are committed to accelerating the drug development process to help you deliver your treatment to patients at a fast pace.
InnoSer can support you in developing your clinical hypothesis by using a pharmacometrics approach. Using tools such as population-based pharmacokinetic modelling (PopPK) we can support you in optimizing your clinical setup for specific substrata of patients.
InnoSer is equipped to provide preclinical studies in rodents as well as safety pharmacology studies in various in vitro model systems. We have an established third-party partner to support your non-rodent preclinical studies. We are currently expanding our capabilities within drug development, and we are performing GLP like studies in preparation of full GLP accreditation.
InnoSer is currently expanding its offerings of in vitro models for specialty toxicology, including new approach methods (NAMs), such as genetic toxicity, mutagenicity, carcinogenicity, liver toxicity, cardiotoxicity and neurotoxicity.
- DMPK properties
- Therapeutic efficacy studies
- MTD (Maximum Tolerated Dose) determination
- Dose Response Relations
- Translational disease models
- Single Dose Toxicity
- Repeated Dose Toxicity
- Medical device biocompatibility