This tutorial identifies the challenges and solutions for integrating all sources of toxicological data involved and helps to understand the non-clinical development and strategies of drug toxicity or safety assessments. The international state of the art of non-clinical evaluation of pharmaceuticals, the interpretation of toxicological data and the acceptability or unacceptability of toxicological risks (benefit/risk assessments) for pharmaceuticals will be discussed.
This tutorial should attract everybody who is interested in or responsible for non-clinical (toxicological) data. This tutorial does not require specialist knowledge in this area.
Who Should Attend
Non-specialists in toxicology, regulatory affairs personnel, clinical colleagues, project team leaders and members
At the conclusion of this tutorial, attendees will be able to:
- Recognise the principles, objectives and strategies of non-clinical safety evaluation of pharmaceuticals
- Identify the need of interactive discussion of quality, non-clinical and clinical data in drug development
- Interest in selection and performing of important non-clinical data for submission of pharmaceuticals