Non clinical

The non-clinical Drug Metabolism and Pharmacokinetic (DMPK) consultant provides services ranging from compound optimization and selection to First-In-Human (FIH) clinical trial application.

• Strategic project support regarding compound optimization in drug discovery with focus on DMPK and pharmacokinetics & pharmacodynamics (PK/PD)
• Design, calculation (WinNonlin) and reporting of non-clinical PK and toxicokinetic (TK) studies
• Design and interpretation (PKPD) of non-clinical pharmacology studies
• Project support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis
• Prediction of human PK and human efficacious doses with help of in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics (PBPK)
• Support regarding scientific publications, scientific advice meetings and due diligence assessments
• Experience in small molecules, peptides, therapeutic proteins, ATMPs, oligonucleotides and radiopharmaceuticals
• Integrated non-clinical support available together with CTC’s sister companies RegSmart Life Science AB, Toxicology Knowledge Team Sweden AB (TKT), Lablytica Life Science AB and MetaSafe AB.