TKT has long experience, and possesses a unique competence, to carry out safety pharmacological risk assessments in drug development (including mainly “small molecules” but also “biologicals”). We offer e.g. the following services:
- Safety pharmacological assessment of drug targets.
- In vitro secondary pharmacodynamic screening of drug candidates with respect to off-target activity.
- Design and evaluation of nonclinical in vitro / in vivo studies to support clinical development programs in accordance with current guidelines (ICH, EMEA, FDA).
- Authoring 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 at CROs.
- In- and outlicensing support / Due Diligence.