Clinical Trial Studies - Bioanalysis-Pharmacokinetic unit
The Bioanalysis Unit analyses drugs and metabolites in biological matrices in samples from clinical studies (phases I, II, III and IV) and preclinical studies. It has accredited experience in developing and checking analytical methods for a wide variety of molecules and applying them in analytical studies, always adapting to the deadlines requested by the pharmaceutical industry.
Bioanalytical validated method List
Certifications
• Since 1998 it has had the GLP compliance
certificate for analysis of
levels of drugs and their metabolites in biological
specimens. Recertification
of September 2009, Certificate nº BPLI/0909/009/CAT.
In addition, the unit carries out its activities following the standards and recommendations below:
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OECD, Principles of Good Laboratory Practice
FDA Guidelines: Bioanalytical Methods Validation for Human Studies
EMEA Guideline (Draft 2009)
ICH Guidelines
Notice to applicants
VICH Guideline (Draft 2009)
GLP Certificate
ANALYTICAL TECHNIQUES
• LC-MS/MS systems:
- Atmospheric pressure ionisation (API) with chemical ionisation and electrospray systems
• HPLC-UV
• HPLC-Fluorescence
FIELDS OF ACTION
• Pharmacokinetics
• Quantitative analysis of drugs and/or metabolites
• Identification of metabolites
• Analysis of thermolabile compounds
• Biotransformation studies with stable isotopes
• Bioavailability
• Bioequivalence
• Metabolism
• Research on new drugs
• Animal tissue residue studies
