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A different question related to the same problem. When making a new
dosage form, say a different salt to the product already on the
market, what pre-clinical studies would be required / recommended
before human trials?
Ian Smith.
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The following message was posted to: PharmPK
Dear Ian,
Primarily you should go for the acute toxicity study, if the new form
is for oral then one more systemic route should also try to check the
systemic exposure. By this study you will be in position to check the
LD50 or GHS category of a product which is already in market and your
new form with different salt. After looking to that results you will
be in position decide that any further investigation is required or not.
I don't think number of studies required when the product is prepared
with different kind of salts.
Thanx & Regards
Chintan Patel
Pharmacology & Toxicology
Cadila Pharmaceuticals Limited
1389, Trasad Road
Dholka - 387 810
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Dear Ian smith
I would like to suggest the following
See the impurity profile of the molecule.If it is fine, stright away
you can go for BE studies.
If not then then you can do genotox followed by 28 day repeated dose
toxicity study in 1 or 2 species to prove the safety.For large
molecules, just do 28 day repeated dose tox study in 1 or 2 species.
Rajasekhar
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