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Symposium 3: BA/BE The Proof of Concept ,[object Object],[object Object],[object Object]
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
Bioequivalence Studies  of a Product ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Characteristics of a BE Study ,[object Object],[object Object],[object Object],[object Object]
Required stages of a product before it reaches the patient ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Necessities for a new product ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is required to carry out these studies? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The Management of the  BE studies  ,[object Object],[object Object]
Review Process for Brand Name and Generic Drug ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What are the requirements for a generic product ? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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
Some Important Details About BE Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],Conclusion  1 ,[object Object],[object Object],[object Object],[object Object]
Conclusion  2 ,[object Object],[object Object]
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.
Final remarks for the young colleagues ,[object Object],[object Object],[object Object]
Acknowledgement
[object Object]

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Significance of BA/BE studies in drug research and evaluation of different aspects

  • 1.
  • 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
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 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
  • 12.
  • 13.
  • 14.
  • 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.
  • 16.
  • 18.