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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

General Toxicology
Reproductive Toxicology
Safety Pharmacology

Isotope Chemistry & Drug Disposition

Regulatory Services
General Toxicology
Reproductive Toxicology
Safety Pharmacology

Isotope Chemistry & Drug Disposition

Regulatory Services

 Need information?

Please contact us if you would like to arrange a visit to your company by one of our representatives, to request a proposal, or for any more information on our services.

info@accelera.org

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