The Centre for Bioavailability Studies (CEB) is a qualified resource, skilled to collaborate with Pharmaceutical Industry in all the different phases of drug development.

The main area of activity has been the performance of Bioavailability/Bioequivalence Studies in human healthy volunteers to assess the efficacy and safety of drugs. CEB 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.

CEB has broaden its competences and facilities to perform clinical trials (phases I to III) which is one of the most relevant areas of activity at the moment with special emphasis on Neurology and Endocrinology. The proximity of the University Hospital of Coimbra and an important relation with a pro-active national pharmaceutical industry are key-points of this development.

Regarding human resources, the team includes a coordinator, a study director and four laboratory technicians also performing study-coordination functions in clinical trials. Multidisciplinary medical doctors, pharmacists and nurses also collaborate in the clinical trials performed by CEB.

The technical resources correspond to the most up-to-date and suitably calibrated equipment, in order to ensure precision and quality of the results presented.

All CEB'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 (certification since 2004 for the performance of Clinical Trials, Bioavailability/Bioequivalence Studies and Drug Dosages).

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.