IN VIVO AND IN VITRO TOXICITY STUDIES

Drug toxicity studies aim to evaluate the safety of a new pharmaceutical compound before it is approved for clinical use. These studies are conducted in different phases and aim to identify any toxic effects that the drug could have on living organisms.

The Biogem Test Facility is authorized by the Ministry of Health to conduct acute and subacute toxicity studies in both in vivo and in vitro models according to the OECD and ISO10993 guidelines of drugs, chemical compounds, food additives and medical devices.

Acute toxicity studies performed on animal models (mice, rats, rabbits) aim to evaluate the toxic effects of a single dose of the drug.

Subacute toxicity studies aim to examine the toxic effects of repeated doses of the drug over a longer period (from a few weeks to a few months) and to identify its target organs and the maximum tolerated dose.

In vivo studies

• OECD Test 423: Acute Oral toxicity - Acute Toxic Class Method
• OECD Test 407: Repeated Dose 28-day Oral Toxicity Study in Rodents
• OECD Test 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents
• UNI EN ISO 10993-10 regulation: Skin irritation and sensitization tests

In vitro studies

• UNI EN ISO 10993-5 regulation: Tests for in vitro cytotoxicity;
• OECD Test 432: In vitro 3T3 NRU phototoxicity test.