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Significance of BA/BE studies in drug research and evaluation of different aspects
- 2. PRACTICAL ASPECTS of BIOEQUIVALENCE STUDIES For the TUFTAD Session: BA/BE The Proof of Concept Prof.Dr.A. Atilla HINCAL Hacettepe University Faculty of Pharmacy Sıhhiye 06100 Ankara,Turkey International Congress “PharmaCon2007”on New Technologies&Trends in Pharmaceutical Industry and Education, Dubrovnik,Croatia, May 22-27, 2007 This session is sponsored by
- 11. BA/BE studies organization platform SPONSOR (Manufacturer) CLINICAL STUDIES (Accredited Centers, Analytical CRO’s) BIOANALYTICAL STUDIES (Accredited Centers, Analytical CRO’s) SCIENTIFIC CONTRACT SERVICE ORGANIZATION HEALTH AUTHORITY LOCAL ETHICAL COMMITTEE Candidate Product for BE CENTRAL ETHICAL COMMITTEE
- 15. Conclusion 3 CSO s and CROs that have long time experience have cumulated knowledge and talent for a specific project management in BE studies. It is possible for such an experienced and established CSO/CRO to reduce the expenses of the sponsor pharmaceutical company, to avoid loss of sources and to optimize the use of time.
- 17. Acknowledgement