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Registerwater restriction before and after dosing [Regulatives / Guidelines]
Dear,
I am totally agree with HS. I would like to appreciate his advise.
now the question was why 1 hr before dosing and 1 hr after dosing water restriction.
so in my opinion, as per pharmacokinetic and what we learned in medicine, water will do the distention of stomach which results in increase in surface area and thats why increases the absorption.
To maintain similarity guideline says only 240 ml of water should be given at the time of dosing. but if it is given less, then you have to mention protocol deviation and just to evaluate the PK parameters afterwards.from my experience i can tell you it will not hamper ur study results.
still que is there why only 240ml???
other wise i am agree with all.
regards
Dr.Tarak Parikh
MD,Physician
I am totally agree with HS. I would like to appreciate his advise.
now the question was why 1 hr before dosing and 1 hr after dosing water restriction.
so in my opinion, as per pharmacokinetic and what we learned in medicine, water will do the distention of stomach which results in increase in surface area and thats why increases the absorption.
To maintain similarity guideline says only 240 ml of water should be given at the time of dosing. but if it is given less, then you have to mention protocol deviation and just to evaluate the PK parameters afterwards.from my experience i can tell you it will not hamper ur study results.
still que is there why only 240ml???
other wise i am agree with all.
regards
Dr.Tarak Parikh
MD,Physician
Complete thread:
- water restriction before and after dosing ssk 2006-08-12 17:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- water restriction before and after dosing Helmut 2006-08-12 18:21
- water restriction before and after dosing ssk 2006-08-13 16:51
- water restriction before and after dosing Helmut 2006-08-13 19:13
- water restriction before and after dosing drks 2006-08-19 09:18
- water restriction before and after dosing Helmut 2006-08-19 12:45
- water restriction before and after dosingDr.Tarak Parikh 2007-04-06 09:27
- water restriction before and after dosing Helmut 2007-04-06 15:34
- water restriction before and after dosing drks 2011-06-10 14:24
- water restriction before and after dosing Helmut 2007-04-06 15:34
- water restriction before and after dosing ssk 2006-08-13 16:51
- water restriction before and after dosing Helmut 2006-08-12 18:21
Ing. Helmut Schütz