In vitro – In vivo comparative Study design for topical dosage form<br />Surang  J.<br />R&D division OSI<br />14 Septembe...
What does “Topical dosage form” mean?<br />External use = skin, hair , nail , mouth,…rectum<br />Solution, Suspension, Oin...
How to check quality?<br />Physical properties…….<br />2. Chemical properties……<br />3. Microbiological properties….<br />...
How to check  Safety ?<br />
Skin allergy patch test<br />
Why do we check Efficiency ?<br />
How to check Efficiency ?<br />Now we are generic drug product developer.<br />FDA said “our product must have bioequivale...
How to check bioequivalence of topical dosage form ?<br />Fda ( Thai FDA) approve 3 method<br />In vitro drug release <br ...
In vitro testing<br />Franz cell diffusion<br />
Sample data of TA 0.1% cream drug release profile compare in 4 brands <br />
Pharmacodynamic study<br />Apply drug product and measure the effect on the body such as BP, redness, HR, etc..<br />Only ...
In human 100 – 4000 cases be required for satisfied.<br />
Conclusion<br />In vitro = outside the living organism<br />In vivo = inside the living organism<br />So…<br />
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IVIVC topical dosage form

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IVIVC topical dosage form

  1. 1. In vitro – In vivo comparative Study design for topical dosage form<br />Surang J.<br />R&D division OSI<br />14 September 2010<br />
  2. 2. What does “Topical dosage form” mean?<br />External use = skin, hair , nail , mouth,…rectum<br />Solution, Suspension, Ointment, Creams, Paste, Suppository,…Powder<br />FDA regulatory “ Quality, Efficiency , Safety must be required for drug product”<br />
  3. 3. How to check quality?<br />Physical properties…….<br />2. Chemical properties……<br />3. Microbiological properties….<br />4. Physical Aspect……….<br />
  4. 4. How to check Safety ?<br />
  5. 5. Skin allergy patch test<br />
  6. 6. Why do we check Efficiency ?<br />
  7. 7. How to check Efficiency ?<br />Now we are generic drug product developer.<br />FDA said “our product must have bioequivalence as same as innovator’s”<br />Efficiency will be measure by bioequivalence between our product and innovator’s<br />We cannot copy innovator’s so how we can check bioequivalence?<br />
  8. 8. How to check bioequivalence of topical dosage form ?<br />Fda ( Thai FDA) approve 3 method<br />In vitro drug release <br />Pharmacodynamic study<br />Clinical trial*****<br />**** US FDA approve only Clinical trial<br />
  9. 9. In vitro testing<br />Franz cell diffusion<br />
  10. 10. Sample data of TA 0.1% cream drug release profile compare in 4 brands <br />
  11. 11. Pharmacodynamic study<br />Apply drug product and measure the effect on the body such as BP, redness, HR, etc..<br />Only use in corticosteroid creams; skin blanching assay; Minolta Chroma meter.<br />
  12. 12. In human 100 – 4000 cases be required for satisfied.<br />
  13. 13. Conclusion<br />In vitro = outside the living organism<br />In vivo = inside the living organism<br />So…<br />
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