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Dear ColleagesI have an inquiry about a combination contaiing the
following ingredients: paracetamole , pheniramaine and ascorbic acid
and the same combination without ascorbic acid. do we need to conduct
a BE study.Kindly send me the refeence for the answer
Your reply is highly appreciated.regardsISra'
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The following message was posted to: PharmPK
I don't think so.
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The following message was posted to: PharmPK
Dear Isra
A brand, NEGRIPIN Pulver is available from a Russian company
"Pharmtechnology" which combines paracetamole, pheniaramine and ascorbic
acid. Regarding BE, someone else can let us know.
Nadeem Irfan Bukhari,
International Medical University,
Kuala Lumpur, Malaysia.
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Hi
It depends on which country you are going to market the product. Some
countries do not require BE for OTC products (as the drug or
combination are available in the market for more years).
I would suggest that you should look for the guidelines of that
particular country in which the product is intended to be marketed and
if requires BE study, then, find out the comparator (innovator)
product available in that country and proceed.
V.Rajesh
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