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Dear All,
During Bioequivalence study for US FDA on any Proton pump inhibitors
(e.g Pantoprazole, Lansoprazole, etc.,) if administer water intake
during post-dose on the day of dosing maintained about 1.2 Liter and
this volume distributed propotonately arround 150mL water for every
two hours until 12 hours post-dose. Will it be excepted by FDA
regulatory?
As per FDA guidline we need to administer water during dosing and
later on after 1hr post dose water intake is ad-libitum. In case if i
administer to volunteers a fixed amount of water at regular interval,
what would be FDA approach? will they accept this or no.
Due to this regular intake of water will the absorption of the PPI
will be affected and will their be any change in the pH and if there
is change in pH will it also affet the absorption with regard to rate
and extend of the drug release.
It would be kind enough if you can share your experience, views and
thoughts.
Regards
Maneesh S
Pharmacokinetics
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