Preclinical drug development

Together with partner (PKI) does consulting in drug development for a small pharma company. Its preclinical portfolio is completed by conducting required nonclinical and later clinical studies with DMPK focus. After a gap analysis by PKI a proposal for study packages on various analytical, drug metabolism and drug-drug interaction aspects has been developed including timelines, cost estimates and suitable CRO partners.

Now that the plans are endorsed we manage the collaborations, evaluate the results and prepare compliant reports. In our partnership, is responsible for the analytical details, early stages and informatics, PKI for the strategic, cost and regulatory aspects.

In the past year, in-vitro safety aspects have been covered, GxP compliant bioanalytical methods for animal and human plasma have been developed and applied to several animal studies. Radioactive material has been synthesized and is used for an ongoing mass balance study.
