Safety pharmacology risk assessment in drug development
- Safety pharmacological assessment of drug targets.
- In vitro secondary pharmacodynamic screening of drug candidates with respect to off-target activity.
- Early phase de-risking of drug candidates.
- Design and evaluation of nonclinical in vitro / in vivo studies to support clinical development programs, including integrated risk assessment of toxicology and safety pharmacology data, in accordance with current guidelines (ICH, EMEA, FDA).
- Authoring and quality assurance of the secondary pharmacodynamic and safety pharmacology parts of regulatory submission documents, i.e CTA, IMPD/IND, IB, AR/DSUR.
- Interaction with regulatory authorities (FDA, MPA, etc ).
- Planning, monitoring and evaluation of safety pharmacology studies (GLP and non-GLP) at CROs throughout the entire drug development process, including problem solving strategies.
- In- and outlicensing support / Due Diligence.
- Tailor-made literature and database searches for specific customer needs.