Departments 
  Clinical Trial Studies
 
 Bioanalysis-Pharmacokinetic unit
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Director:   Dr. Pilar Pelagio
    
The Bioanalysis-Pharmacokinetic Unit carries out analyses of pharmaceutical chemicals and/or metabolites in biological fluids, and samples from clinical trial studies (phase I, II, III, IV) and preclinical studies. It has extensive experience in the development and validation of analytical methods for a wide range of molecules, and their application to analytical studies, within the time limits necessary for the pharmaceutical industry.
CERTIFICATIONS
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- GLP Certificate for drug and metabolite level analyses in   biological samples. Re-certification July 2004, Certificate   no. BPLI/0707/008/CAT.
- The unit carries out its activities according to the following   norms and guidelines:
      - OECD, Principles of Good Laboratory Practice
      - FDA Guidelines: Bioanalytical Methods Validation for Human         Studies
      - ICH Guidelines
ANALYTICAL TECHNIQUES
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- System of LC/MS/MS:
      - Atmospheric pressure ionisation (API) with chemical
        and electrospray ionisation systems
- HPLC / UV
- HPLC / Fluorescence
WORKING AREAS
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- Pharmacokinetics
- Quantitative analysis of drugs and/or metabolites
- Identification of metabolites
- Analysis of thermolabile compounds
- Studies of biotransformation with stable isotopes
- Bioavailibility
- Bioequivalence
- Metabolism
- Investigation of new pharmaceutical drugs
Phase I Clinical Trials
Phase II-IV Clinical     Trials
Bioanalysis-     Pharmacokinetic
Pharmacogenetics