Bioanalytical Services
Accelera offers a full range of bioanalytical and pharmacokinetic services for drug discovery and development. A validated LIMS system (Watson) is used to manage all operations from sample tracking to data analysis, allowing the integrated design, conduct and reporting of bioanalytical and PK studies.
Clinical and Preclinical Bioanalysis
State-of-the-art LC-MS-MS instrumentation
Large molecules bioanalysis with ELISA, ALPHALISA, BIOPLEX assays Accredited as bioanalytical lab for Phase I Clinical Studies Facilities for light-sensitive and cytotoxic compounds
Synthesis of isotopically labelled internal standards
Pharmacokinetic Analysis
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.
Other Services
Isotope Chemistry & Drug Disposition
Isotope Chemistry & Drug Disposition
Need information?
Welcome and Check out our new motion picture!