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Registeradditional water to subject [Study Performance]
Dear All,
If we give additional water during dosing to a single subject, will it affect the solubility of the product and subsequently on the absorption, pk and stats results. However it depends on the amount of water what we have given.
If it occurs in P-I, can we give the same amount of additional water to the same subject in next period(s) to avoid variability.
Can we drop the subject from the study, to avoid the queries from the regulatory.
Regards
Raghu
If we give additional water during dosing to a single subject, will it affect the solubility of the product and subsequently on the absorption, pk and stats results. However it depends on the amount of water what we have given.
If it occurs in P-I, can we give the same amount of additional water to the same subject in next period(s) to avoid variability.
Can we drop the subject from the study, to avoid the queries from the regulatory.
Regards
Raghu
Complete thread:
- additional water to subject suchit_bhavsar 2013-06-25 11:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- additional water to subject Dr_Dan 2013-06-25 14:38
- additional water to subject Helmut 2013-06-25 15:56
- additional water to subject Dr_Dan 2013-06-25 16:24
- additional water to subject suchit_bhavsar 2013-06-26 05:20
- additional water to subjectraghu 2013-06-28 08:24
- Science driven decisions Helmut 2013-06-28 14:22
- additional water to subjectraghu 2013-06-28 08:24
- additional water to subject Helmut 2013-06-25 15:56
- additional water to subject Dr_Dan 2013-06-25 14:38
Ing. Helmut Schütz