Prior to the administration of a new pharmaceutical product to humans, its safety is evaluated in vitro or in animals during development. The objective of the non-clinical (preclinical) safety assessment is generally to characterise the toxic effects with respect to target organs, dose dependency, the relationship between clinical findings and exposure to the compound, and potential reversibility of findings. All these data support the clinical trials and allow the estimation of an initial, safe starting dosage for the human trials and the identification of parameters for the clinical monitoring of potential adverse effects.
Safety testing during drug development is a well-regulated process, framed by guidelines provided by EMA, FDA, ICH and OECD that have to be taken into consideration while adopting an individual testing strategy suited to the requirements of national and international authorities.
The in vitro and in vivo studies address the identification of the most human-like animal species for safety evaluation as well as genetic and general toxicity, safety pharmacology and if necessary other non-clinical studies such as reproduction toxicity and carcinogenic studies. Studies to assess phototoxicity, immunotoxicity as well as abuse liability are considered on a case-by-case basis.
Aurigon offers a high level of expertise in customising study packages and study outlines according to your specific needs and requirements, your clinical testing strategy, and the stage of development. For more than 15 years we have been successfully testing small molecules, peptides, biologics, vaccines, ATMPs and medical devices for our customers. Our comprehensive services cover all important aspects of safety testing including the provision of study data in SEND submission-ready format. All studies are of course conducted in GLP-certified facilities in accordance with the latest guidelines (e.g. EMA, ICH, FDA, WHO). For us, animal welfare is not just a case of following the 2010/63/EU guideline; we are fully committed to ensuring the well-being of experimental animals. We believe that the safety of medical compounds can be reliably assessed without causing unnecessary pain.