The test drug will next be examined in detail in the laboratory to determine whether it is safe. "Safe in this context means that it has no harmful effects that could lead to unacceptable side effects when used in humans in the future" says Jürgen Zorn. The department where Zorn works is responsible for product safety throughout the clinical development process and after a new therapy has been successfully approved. "Toxicological studies conducted in the laboratory, for example on cell cultures and/or animals, provide important information for subsequent clinical trials."
This is required by law: Before a potential new drug can be tested in humans, preclinical studies must verify how it is likely to behave in the body and whether it will not cause any undesirable side effects. The information obtained is then extrapolated to humans. Only active ingredients that prove to be effective and safe here will continue their journey.
" We monitor and evaluate the safety findings from the preclinical studies across all clinical trials - even after the drug has been approved. "
Jürgen Zorn, Head of Pharmacovigilance, CSL R&D Marburg
