Could Phase III Clinical Trials be taken without Phase I and II ?

[SGquality]

My questions is if Phase III Clinical Trials could be undertaken without having the Phase I and II clinical studies done ? The drug under discussion is an already existing product in the market.

Could studies like pharmacokinetics and pharmacodynamics be done as substitute of Phase I and II ?

 

[Stijloor]

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[Ajit Basrur]

My questions is if Phase III Clinical Trials could be undertaken without having the Phase I and II clinical studies done ? The drug under discussion is an already existing product in the market.

Could studies like pharmacokinetics and pharmacodynamics be done as substitute of Phase I and II ?

Yes that approach is acceptable.