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 publication, scientific advice meetings and due diligence assessments
- Experiences with small molecules, peptides, therapeutic proteins, ATMPs, oligonucleotides and radiopharmaceuticals
- Integrated non-clinical support available together with CTC’s sister companies Toxicology Knowledge Team, Lablytica and RegSmart
The clinical Pharmacologist provides pharmacokinetic (PK) and pharmacodynamic (PD) services ranging from integration of early development PK/PD data to design of the first-in-human (FIH) studies to proof-of-concept trials.
- Non-clinical support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis
- Predictions of human PK (in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics)
- Summarize non-clinical and clinical PK sections in the IMPD and IB documentation
- Support, participation and preparation of data for meetings with regulatory authorities
- Design of FIH studies with adaptive design and dose setting
- Performance of interim reports of blinded data and participate in regular safety committee meetings in dose escalation studies
- PK and PK/PD calculations (WinNonlin), modeling and simulation, and reporting
- Design of metabolites in safety testing (MIST) studies and strategies
- Design of phase I studies such as bioavailability, bioequivalence, biosimilar, DDI, EPQT, renal and hepatic impairment, human ADME, PET and MRI studies.
- Design of biomarker strategies and phase IIa studies
- Microdosing (PET and microdialysis) and local administration of drugs in various organs
- Full-service studies in dedicated research clinics (including FIH approved clinic) and in-house support services with medical writing, pharmacovigilance, data management and statistics, bioanalysis and QA