The Centre of Clinical Pharmacology (CFC) is a qualified resource, to work closely with Pharmaceutical Industry in all the different phases of drug development.

The main area of activity is the performance of bioavailability/bioequivalence studies in human healthy volunteers to assess the efficacy and safety of drugs. CFC can be responsible for the elaboration of protocols and other documents needed for the studies execution, the organization of all documents to regulatory authorities submission and the development of specific analytical methods for the drugs quantification.

The strengthening of the collaboration with INFARMED will permit the performance of independent bioavailability and bioequivalence studies that are need to monitor the market.

CFC has been collaborating with BIAL conducting clinical studies for their R&D Department. This has been recently strength with 2 new study requests.

Regarding human resources, CFC has a coordinator, a study director and three laboratory technicians/study-coordinators. 15 consultants medical doctors, one pharmacist and five nurses who collaborate in the clinical trials performed by CFC.

CFC is equipped with the most up-to-date and suitably calibrated equipment for the development and validation of analytical methods in order to ensure precision and quality of the results presented.

All CFC's activities are performed according to Good Laboratory Practices (certification since 1999 by INFARMED for the performance of bioavailability/bioequivalence and pharmacokinetic studies), Good Clinical Practices and ISO 9001 Guidelines.

CFC has broaden its competences to support clinical trials (phases I to III) with special emphasis on the areas of neurology and endocrinology. The proximity of the University Hospital of Coimbra is a key-point of this development.

Areas of expertise

• Studies of absolute bioavailability of a drug.
• Elaboration of documentation to submit for the regulatory authorities, associated with bioequivalence studies.
• Bioequivalence studies of pharmaceutical products having the same drug in the same formulation or different formulations.
• Elaboration of documents for clinical trials.
• Development and validation of analytical methods.
• Dosage of drugs in the finished product or during the manufacturing process and in biological matrixes.
• Clinical studies on the variability of different batches of preparation from a single manufacturer.
• Chemical control of raw materials and manufactured products.
• Scientific advisor of reviews or reports for the introduction of drugs in Portugal and the European Union.