The Toxicology and Bioanalysis unit provides an extensive analytical service with the aim of supporting the development of products for both Human and Veterinary Pharmaceutical Industry.
FIELDS OF ACTION:
They have experience in the development and validation of analytical methods for a wide variety of molecules, covering from small synthetic chemical drugs (small molecule) to innovative biotech products (large molecule) within the following fields:
- Pharmacokinetics, Bioequivalence, Bioavailability and interaction with drug studies.
- Phase I Clinical studies (first-in-man), Phase II…
- Pharmacokinetics, toxicokinetics and Bioavailability in preclinical studies.
In addition, it offers support in the field of Biomarkers: validation methods of commercial kits implemented in routine Laboratory and new kits, as well as the transfer of immunoassay methods to LC-MS/MS systems.
Method validation is performed along with the Principles of Good Laboratory Practice (GLP) and quality standards as required by Agencies (EMA, FDA, ANVISA ...)
The Bioanalysis Unit works with an animal experimentation, farm certified under GLP, participating in Bioequivalence Studies, Pharmacokinetics and Animal Tissue Residue in multiple matrices.
Since 1998, GLP compliance certificate for analysis of levels of drugs and their metabolites in biological specimens. This certificate is updated every two years. No. BPLI/1311/012/CAT (September- 2013)
STANDARDS AND RECOMMENDATIONS:
- OECD, Principles of Good Laboratory Practice
- FDA Guidelines: Bioanalytical Methods Validation for Human Studies (2001)
- EMEA Guideline (2011)
- ICH Guidelines
- Notice to applicant
- VICH Guideline (2011)
- LC-MS/MS systems: Atmospheric pressure ionization (API) with chemical ionization and electrospray systems
- Inductively coupled plasma mass spectrometry (ICP-MS)
- RIA, CLIA, ELISA.