Safety pharmacology

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.

For further information and requests for quotations, please use our contact form, or contact any of our consultants.

Drug development