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


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PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education"
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Significance of BA/BE studies in drug research and evaluation of different aspects

  1. 1. Symposium 3: BA/BE The Proof of Concept <ul><li>Prof.Dr. Y. Ilker Kanzik </li></ul><ul><li>Prof.Dr. Nevin Celebi </li></ul><ul><li>Prof.Dr-Jose Augusto Guimaraes Morais </li></ul>
  2. 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. 3. Bioequivalence Studies of a Product <ul><li>What is it based on ? </li></ul><ul><li>Scientific studies </li></ul><ul><li>Technologies used in studies </li></ul><ul><li>Related regulations </li></ul><ul><li>organization </li></ul><ul><li>coordination </li></ul><ul><li>communication </li></ul><ul><li>monitoring, auditing and </li></ul><ul><li>inspections </li></ul><ul><li>consciousness of mission </li></ul><ul><li>and responsibility </li></ul><ul><li>attention </li></ul><ul><li>labor </li></ul><ul><li>self-sacrifice </li></ul>
  4. 4. Characteristics of a BE Study <ul><li>a product’s bioequivalence study is a “Science based regulatory affairs’ project ” to be submitted to health authorities, </li></ul><ul><li>a combination of studies based on specializations/expertise </li></ul><ul><li>all these factors should be based on a very good documentation system, </li></ul><ul><li>this could be possible with “bioequivalence studies project management” </li></ul>
  5. 5. Required stages of a product before it reaches the patient <ul><li>Research </li></ul><ul><li>Development </li></ul><ul><li>Clinical Research </li></ul><ul><li>Production </li></ul><ul><li>Control, Analysis </li></ul><ul><li>Distribution, Marketing </li></ul><ul><li>Purchasing </li></ul>
  6. 6. Necessities for a new product <ul><li>Development of an active ingredient </li></ul><ul><li>Research towards invention </li></ul><ul><li>ADME studies </li></ul><ul><li>Active ingredient/Excipient material obtention </li></ul><ul><li>Formulation development </li></ul><ul><li>Production of dosage forms </li></ul><ul><li>Clinical research </li></ul>
  7. 7. What is required to carry out these studies? <ul><li>Cost/Expense </li></ul><ul><li>Sources: location challenges </li></ul><ul><li>Know-how, problem solving </li></ul><ul><li>Speciality </li></ul><ul><li>Quality </li></ul><ul><li>Industrial risk </li></ul><ul><li>Obtaining rapid results </li></ul><ul><li>Complete service </li></ul><ul><li>Finance risks </li></ul>
  8. 8. The Management of the BE studies <ul><li>carried out by planners of a pharmaceutical company itself </li></ul><ul><li>may outsource to a CRO to carry out the study </li></ul>
  9. 9. Review Process for Brand Name and Generic Drug <ul><li> Brand Name Drug Generic Drug </li></ul><ul><li>1. Chemistry 1. Chemistry </li></ul><ul><li>2. Manufacturing 2. Manufacturing </li></ul><ul><li>3. Controls 3. Controls </li></ul><ul><li>4. Labeling 4. Labeling </li></ul><ul><li>5. Testing 5.Testing </li></ul><ul><li>6. Animal Studies </li></ul><ul><li>7. Clinical Studies 6.Bioequivalence </li></ul><ul><li> 8. Bioavailability </li></ul>
  10. 10. What are the requirements for a generic product ? <ul><li>Same active ingredient(s) </li></ul><ul><li>Salt, base, anhydrous, hydrated, inclusion complexes </li></ul><ul><li>Same route of administration </li></ul><ul><li>OK! </li></ul><ul><li>Same dosage form </li></ul><ul><li>YES, But…. </li></ul><ul><li>Same strength </li></ul><ul><li>YES, But….. </li></ul><ul><li>Same conditions of use </li></ul><ul><li>OK! </li></ul><ul><li>Compared to reference (brand name) product </li></ul><ul><ul><li>How the reference products should be determined? </li></ul></ul><ul><ul><li>Difficulties </li></ul></ul>
  11. 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. 12. Some Important Details About BE Studies <ul><li>Reference Product Search and Selection </li></ul><ul><li>Comparison of Test and Reference Product Dissolution Profiles </li></ul><ul><li>Formulation : API+Excipients </li></ul><ul><li>BE Investigational Product’s Shipment/Receipt Records </li></ul><ul><li>BE Investigational Product’s Return/Receipt Records </li></ul><ul><li>Test/Reference Products Labeling </li></ul><ul><li>At the end of the research –if encountered- Adverse Effect List </li></ul>
  13. 13. <ul><li>“ BE studies are the science based research” </li></ul><ul><li>“ BE studies are the science based regulatory </li></ul><ul><li>affair s ” </li></ul>Conclusion 1 <ul><li>BA/BE studies are scientific affairs requiring </li></ul><ul><li>team work. </li></ul><ul><li>It is possible and rational to perform them </li></ul><ul><li>within companies with high R & D investment </li></ul>
  14. 14. Conclusion 2 <ul><li>On the other hand, for small and medium-scale sponsor pharmaceutical companies to enter these studies (in-house) a very large investment is required and this is not rational. </li></ul><ul><li>It is understood that problems could be solved more rapidly by the help of more scientific and specialized staff of CSOs and/or CROs to which the sponsor pharmaceutical company may outsource its BE study . </li></ul>
  15. 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. 16. Final remarks for the young colleagues <ul><li>The session speakers will talk some of issues in BE topic </li></ul><ul><li>You, as future professionals, may judge and decide which topics are in your interests’ limites in their presentations </li></ul><ul><li>If we may give you the toughts for your future plans, the session will be counted as “succesful”. </li></ul>
  17. 17. Acknowledgement
  18. 18. <ul><li>Thank you </li></ul>