Bioanalysis
The Bioanalysis unit offers an extensive analytical service in order to support the development of products for both the human pharmaceutical industry and the veterinary industry.
Fields of action
Human
The unit has proven experience in the development and validation of analytical methods for a wide variety of molecules, ranging from small-molecule chemical drugs to innovative large-molecule biotechnology products within the following fields of action:
- Pharmacokinetics, Bioequivalence, Bioavailability and drug interaction studies
- Phase I trials (first-in-man), Phase II…
- Pharmacokinetics, toxicokinetics and bioavailability in preclinical studies.
Methods are validated in accordance with Good Laboratory Practices (GLP) and according to the quality standards required by different Agencies (EMA, FDA, ANVISA...).
Veterinary
The Bioanalysis of Laboratorio Echevarne unit has been working for some years with a local animal testing facility with GLP certification, taking part in studies on Bioequivalence/Pharmacokinetics and in residue studies in animal tissues in multiple matrices.
Certification
The GLP Compliance Certificate has been available since 1988 for the analysis of drug levels and their metabolites in biological specimens. This certificate is updated every two years.
Standards and recommendations
• OECD, Principles of Good Laboratory Practice
• FDA Guidelines: Bioanalytical Methods Validation for Human Studies (2018)
• EMEA Guideline (2011)
• ICH Guidelines
• Notice to applicant
• VICH Guideline (2015)
Analytical techniques
• UHPLC-MS/MS systems: Atmospheric pressure ionisation (API) with chemical ionisation and electrospray systems
• HPLC-UV
• HPLC-Fluorescence
• Mass spectrometry with inductively coupled plasma (ICP-MS)
• RIA, CLIA, ELISA
