claim & reasonable probability
TRANSCRIPT
Claim & Reasonable ProbabilityUnderstand Product, Control Process & Demonstrate Quality
Roohi B. Obaid & Obaid AliCivil Service Officer
Drug Regulatory Authority of Pakistan
Claim & Reasonable ProbabilityUnderstand Product, Control Process & Demonstrate Quality
Part ARoohi B. Obaid
Not the view of DRAP
Current judgment of speaker
No obligation on DRAP
Regulatory experience
ReferencesFDA, WHO
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If someone come and claims
that he or she has discovered a
drug for Nausea ....
What would you like to see ..
Review and
Evaluation
Regulatory Authorities
Label Review and alerts
Generic Drugs
If it is claimed that someone
used same materials and
developed generic version ...
What would you like to see ..
Pre Clinical
Clinical Phase 1
Clinical Phase 2
Clinical Phase 3
Absorption
ADistribution
DMetabolism
MElimination
E
Absorption is a real challenge
Absorption is a real challenge
Solubility Permeability
Absorption is a real challenge
Solubility Permeability
Will formulation be able to deliver similar
amount of drugs with similar rate?
Bioavailability
Absorption is a real challenge
Solubility Permeability
Will formulation be able to demonstrate
similar pattern of both?
Bioequivalence
Reaching in Blood
Site of Action
Excreting from Body
Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
GIT
Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
GIT pH
Reaching in Blood
Site of Action
Excreting from Body
Disintegrate Dissolution Absorption
Solubility Permeability
6.84.61.2GIT pH
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
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
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
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
Claim & Reasonable ProbabilityUnderstand Product, Control Process & Demonstrate Quality
Photo CourtesyBusiness Insider Thank You
Warm up exercise
Fundamental Scenarios and Bio-studies or Dissolution Studies
Agree
Agree
500 100
Have you ever imagined a situation
where a tablet can come out from the
body as it is?
If so, can it produce effect
If a tablet is disintegrated, what are the
options it will not reach to the blood
If a tablet is dissolved, what are the
options it will not reach to the blood