Bioequivalence /bioavailability studies (performed on maximum 32 volunteers simultaneously)

• Single/multiple dose;
• Different forms of pharmaceutical presentation/ different ways of administration;
• Drugs products with immediate /extended release;
• Standard studies under fasting conditions/after lunch;
• Pilot studies.

• Selection of appropriate study design;
• Wording of study protocol;
• Designing of CRFs;
• Volunteers recruitment;
• Bioanalytical determination of the active substances/methabolites (see the List of the validated/in development bioanalytical methods);
• Dissolution profiles or in vitro bioequivalence studies;
• Pharmacokinetic evaluation and data statistic processing (Statiscal services/statistical analyses);
• Elaboration of study reports
• Archiving of all documents.