Annual Report of Activities CNC 2008 - Center for Neuroscience and ...

2.2. Centre for Bioavailability StudiesThe Centre for Bioavailability Studies (CEB) was structured to be a qualified resource, skilled to collaborate withPharmaceutical Industry in all the different phases of drug development.The main area of activity has been the performance of Bioavailability/Bioequivalence Studies in human healthyvolunteers to assess the efficacy and security of drugs. The elaboration of protocols and other documents neededto the studies execution, the organization of the processes to the regulatory authorities approval and thedevelopment of analytical methods for the drugs quantification have been of CEB’s responsibility.Recently, CEB improved competences and facilities for clinical trials performance (Phases I to III), one of the mostrelevant areas of activity at the moment. The proximity of the University Hospital of Coimbra and an importantrelation 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 techniciansalso performing study‐coordination functions in clinical trials. Multidisciplinary medical doctors, pharmacistsand nurses also collaborate in the clinical trials executed at CEB.The technical resources correspond to the most up‐to‐date and suitably calibrated equipment, in order to ensureprecision and quality of the results presented.All the activities performed at CEB follow quality standards such Good Laboratory Practices (certification since1999 by INFARMED for the performance of Bioavailability/Bioequivalence and Pharmacokinetic Studies), GoodClinical Practices and ISO 9001 Guidelines (certification since 2004 for the performance of Clinical Trials,Bioavailability/Bioequivalence Studies and Drug Dosages at CEB).Areas of ExpertiseStudies of absolute bioavailability of a drug.138Elaboration 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 differentformulations.Elaboration of documents associated with clinical trials performance.Clinical trials performance.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.Organisation and scientific coordination of reviews or reports for the introduction of drugs in Portugal and theEuropean Union.