The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals
Owner/Developer: European Journal of Pharmacology
In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary.
|Audience:||Researchers - Scientists - Industry|
|User access:||Restricted access - Fee-based access|
|Relevance:||Replacement - Reduction - Refinement|
|Purpose:||Documentation and information - Regulatory testing - Toxicological and safety evaluation - Efficacy testing|
|Technology/Tools:||Animal testing (in vivo)|
Did you find what you were looking for?Yes, I found it! No, I did not!
Thanks for your feedback! Please note that we cannot reply to you unless you send us an email.
What are you looking for?
We value your feedback so we can improve the information on the page. Please add your email address if you would like a reply. Thank you in advance for your help.!Please contact us by email if you have any questions.