Bioanalytical Method Development and Validation
Provision of a suitable bioanalytical method is an essential prerequisite for any pharmacokinetic study. LC-MS-MS methods can be developed extremely rapidly for discovery support, while further development and refinement required prior to formal validation.
Clinical and Preclinical Bioanalysis
- State-of-the-art LC-MS-MS instrumentation
- Rapid turnaround bioanalysis for Phase I Clinical Studies
- Fast method development for discovery support
- Facilities for light-sensitive and cytotoxic compounds
- Automated sample handling
- Synthesis of isotopically labelled internal standards.
- PK and TK evaluation in rodents and non rodents
- Optimization of PK sampling
- Designing PK studies and sub-studies
- Compartmental and non-compartmental analysis
- Interspecies Scaling
- Clinical Studies
- Statistical assessment of dose proportionality.
- Bioequivalence/Bioavailability studies
- Food effect studies
- SAD/MAD studies
- Drug-drug interaction studies
- Special population (ie. Hepatic and renal impairment studies)
- Gender differences
- PK/PD modeling and simulation
- Population PK and PK/PD
- PB-PK modelling
Characterization of the pharmacokinetics of drugs in various species, including humans, following different administration routes combining the physicochemical properties of a compound with physiological and anatomical information.
The PB-PK basic model can be customized taking into consideration project-specific items (e.g. elimination routes, transporters, permeability limitation, drug-drug interaction etc.), target tissues (for tox/pharm) and project-specific animal models.Bioanalyses, PK and TK analyses and reporting are performed in accordance with GLP and relevant ICH, EMEA, and FDA guidelines and routinely audited by our Accelera Quality Group unless specified otherwise.
Validated software systems devoted to bioanalysis and PK include: Phoenix-WinNonlin (Certara), Watson (Thermo Scientific), NONMEM (ICON) and SAS (SAS Institute, Inc.). Use of validated software in accordance with requirements stipulated by regulatory bodies.