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CCK Technical Group Session 1 - A

Dissolution & Bioavailability Group

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CCK Technical Group Session 1 - A

  1. 1. CCK Technical Groups – Session 1-A Dissolution & Bioavailability Group 13 Jan 2019 Obaid Ali & Roohi B. Obaid
  2. 2. Reference: Dissolution Method Development for Generic Drug Product Banu Sizanli Zolnik, DOB, OPQ, CDER, FDA
  3. 3. To control consistency To control the process To assure the quality Tool
  4. 4. Critical for formulation development Tool
  5. 5. To get waiver from bio-studies Tool
  6. 6. To use as in-vitro bioequivalence studies Tool
  7. 7. Alcohol induced dose dumping Tool
  8. 8. Post marketing approval manufacturing change Tool
  9. 9. Process Parameter Material Attributes Formulation Variables Dissolution
  10. 10. Evaluation Discrimination Criteria Method
  11. 11. Solubility Apparatus Media Evaluation
  12. 12. Rotation speed Sink conditions Surfactant Evaluation
  13. 13. Differentiates drug product manufactured under target conditions VS Formulation with meaningful variations for the most relevant manufacturing variablesDiscrimination
  14. 14. Particle Size Clinical Batch Multiple batches Discrimination
  15. 15. Manufactured product variants with different release characteristics 1- Manufactured product variants with different release characteristics 1
  16. 16. Manufactured product variants with different release characteristics Select optimal dissolution method with adequate discriminating power 1 2 2- Select optimal dissolution method with adequate discriminating power
  17. 17. Manufactured product variants with different release characteristics Select optimal dissolution method with adequate discriminating power Determine bioavailability for product variants 1 2 3- Determine bioavailability for product variants 3
  18. 18. Manufactured product variants with different release characteristics Select optimal dissolution method with adequate discriminating power Determine bioavailability for product variants Determine dissolution rates resulting in similar in vivo performance 1 2 4- Determine dissolution rates resulting in similar in vivo performance 3 4
  19. 19. Manufactured product variants with different release characteristics Select optimal dissolution method with adequate discriminating power Determine bioavailability for product variants Determine dissolution rates resulting in similar in vivo performance Dissolution specifications chosen to ensure similar (BE) product performance1 2 5- Dissolution specifications chosen to ensure similar (BE) product performance 3 4 5
  20. 20. Manufactured product variants with different release characteristics Select optimal dissolution method with adequate discriminating power Determine bioavailability for product variants Determine dissolution rates resulting in similar in vivo performance Dissolution specifications chosen to ensure similar (BE) product performance Illustration of dissolution profile based on BE batches/ reference 1 2 6- Illustration of dissolution profile based on BE batches/ reference 3 4 5 6
  21. 21. BE batches 85% drug is dissolved Time Q = 80% of drug Criteria
  22. 22. Application is not supported with dissolution method development data Common Deficiencies
  23. 23. Failed to demonstrate that the dissolution method is discriminating Information on critical material attributes & process parameters are missing Common Deficiencies
  24. 24. Data do not support the proposed acceptance criteria Common Deficiencies
  25. 25. There is no dissolution data for the lower strength waiver Multi media testing for MR products Common Deficiencies
  26. 26. Method transfer report is not available when method validation is done at different sites Common Deficiencies
  27. 27. Dissolution data collected on aged lots Common Deficiencies
  28. 28. Individual dissolution data is not submitted Common Deficiencies
  29. 29. Remember Dissolution method is product specific, nothing cannot be assumed, everything has to be justified
  30. 30. Thanks

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