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The following message was posted to: PharmPK
Dear All,
If a company is developing new formulation and intend to do
preclinical PK before entering into Phase I PK/PD, The preclinical
study design consisit of 2 formulation of intended drug and
comparator/innovator at 3 doses (low mid high) of each drug.
Which stat model is to be applied to compare PK parameters of each
drug. and when it can be said that new formulation is having similar
PK profile with the innovator/comparator drug.
thanks in advance,
vishal
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The following message was posted to: PharmPK
Hello Vishal,
I think you are mixing two thing at a time here I would like to clarify
that if it's NCE than there will not be an innovator /comparator. Here I
am assuming that your are considering NCE molecule
1. If it's NCE we need to final preclinical PK in higher species like
Dog or monkey with similar clinical phase-1 formulation
2. No need to do with three doses PK like low middle and high we can do
with only single dose PK
3. If you want to statics calculation we can use Winnolin for PK
parameter calculation
If you need any clarification feel free to contact us
Regards
Ashok Meena
-
Ashok Kumar Meena
Pharmaceutical Development, Jubilant Biosys Limited, #96, Industrial
Suburb, 2nd Stage, Yeshwanthpur
Bangalore-560022
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