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hi everyone,
i have got some doubt.
Drug A, Drug B and drug Cis available in india as combination.
If we want to add one more drug (say Drug D) instead Drug B.
And Drug D superior of Drug B.
Drugs A,B & D are in the same class.
Combi of ABC is available in india.
But Drug D is not available in india and at the same time it is
available in other countries like USA.
Now my question is In this condition Whether we will have to go for
Clinical trials or BE.
Kindly clarify in this regard.
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As the Drug D is not available in india, As per schedule Y,a clinical
trial will be required for the FDC containing the Drug D.
rgds
Ashis
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hi ashish
thank you for kind response.
ok as per schedule Y we can proceed. I have some more doubt. ie
Which phase it will comes under whether III or IV. Is it any rules
about number of volunteers for the study. since it is clinical trial
we need to conduct in hospitals we will get more patients or
volunteers. so number will question. kindly clarify.
devisha.
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