In Vivo Pharmacokinetics & PK/PD Support
Pharmacokinetics is the study of the concentration of compound in the body over time, and is related to the absorption, distribution, metabolism, excretion (ADME) of a compound (often described as ‘what the body does to the drug’).
Obtaining pharmacokinetic data is a key requirement in the evaluation of new chemical entities providing validation of any in vitro-in vivo extrapolations and an understanding of ADME processes in preclinical species which can provide confidence in translation to man and/or highlight key risks.
Pharmacokinetics Services
- Various administration routes: intravenous (incl. infusion), per os (PO), intra-peritoneal, subcutaneous, intra-cerebrospinal and intramuscular
- Cassette PK screening of up to 5 compounds simultaneously
- Different sampling routes: jugular vein cannulation, cardiac puncture, tail vein microsampling, retro-orbital
- Different matrices: blood, plasma, cerebrospinal fluid, tissues, bile, urine and faeces
- Data analyzed with the latest version of Phoenix® WinNonlin® software, using rigorous acceptance criteria
- Solid state evaluation, salt screening and enhanced formulation for problematic compounds
- Biomarker development and application within projects
- Support of pharmacodynamic and efficacy study design
PK/PD Modeling
- The relationship between concentration-time and response-time profiles varies with different targets and the position of a target in a biological pathway. The team provides analysis and interpretation of pharmacokinetic/pharmacodynamic (PKPD) relationships in support of PD and/or efficacy studies.
- We provide simulations from early PK data to assist study design and support translation to man. Early assessments of clinical dose and associated exposure can be explored by thorough evaluation of the relationships between response, concentration and time.
- Analysis of biomarkers can also be conducted at Evotec as it can greatly enhance the process; integration of such information in static or ideally dynamic (physiologically-based pharmacokinetic; PBPK) models form the foundation for drug discovery and safety risk assessment.