Claim & Reasonable Probability Understand Product, Control Process & Demonstrate Quality

1. Claim & Reasonable Probability
Understand Product, Control Process & Demonstrate Quality
Roohi B. Obaid & Obaid Ali
Civil Service Officer
Drug Regulatory Authority of Pakistan

2. Claim & Reasonable Probability
Understand Product, Control Process & Demonstrate Quality
Part A
Roohi B. Obaid

3. Not the view of DRAP
Current judgment of speaker
No obligation on DRAP
Regulatory experience
References
FDA, WHO
D
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4. If someone come and claims
that he or she has discovered a
drug for Nausea ....
What would you like to see ..

9. Review and
Evaluation
Regulatory Authorities

10. Label Review and alerts

11. Generic Drugs

12. If it is claimed that someone
used same materials and
developed generic version ...
What would you like to see ..

13. Pre Clinical
Clinical Phase 1
Clinical Phase 2
Clinical Phase 3

14. Absorption
A Distribution
D Metabolism
M Elimination
E
Absorption is a real challenge

15. Absorption is a real challenge
Solubility Permeability

16. Absorption is a real challenge
Solubility Permeability
Will formulation be able to deliver similar
amount of drugs with similar rate?
Bioavailability

17. Absorption is a real challenge
Solubility Permeability
Will formulation be able to demonstrate
similar pattern of both?
Bioequivalence

18. Reaching in Blood
Site of Action
Excreting from Body

19. Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption

20. Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability

21. Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
GIT

22. Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
GIT pH

23. Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
6.84.61.2GIT pH

24. Scenario A
If innovator changes the
formulation
of its new drug, what do you think it
requires clinical studies or bio-studies
or comparative dissolution studies or
none of them

25. Scenario B
If innovator changes the
manufacturing site
of its new drug, what do you think it
requires clinical studies or bio-studies
or comparative dissolution studies or
none of them

26. Scenario C
If innovator changes the
manufacturing process
of its new drug, what do you think it
requires clinical studies or bio-studies
or comparative dissolution studies or
none of them

27. Scenario D
If innovator changes the
manufacturing equipment
of its new drug, what do you think it
requires clinical studies or bio-studies
or comparative dissolution studies or
none of them

28. Claim & Reasonable Probability
Understand Product, Control Process & Demonstrate Quality
Photo Courtesy
Business Insider Thank You

29. Warm up exercise
Fundamental Scenarios and Bio-studies or Dissolution Studies

31. Agree

32. Agree
500 100

33. Have you ever imagined a situation
where a tablet can come out from the
body as it is?
If so, can it produce effect

37. If a tablet is disintegrated, what are the
options it will not reach to the blood

38. If a tablet is dissolved, what are the
options it will not reach to the blood