Investigation of ... [Design Issues]
Dear Helmut,
Up to now my understanding of a bioavailability study was: A study with the aim to study the extent of availability in the body, without the aim to show equivalence. F.i. intra-venious application versus oral.
IMHO this is a very sophisticated and nitpicking attitude, suitable to wow NLYW
.
In the same spirit you can't speak about non-inferiority or superiority studies.
But: "Jedem Tierchen sein Pläsierchen" (rough translation "To each their own"). Especially if it (the beastie) is an assessor.
❝ We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result).
Up to now my understanding of a bioavailability study was: A study with the aim to study the extent of availability in the body, without the aim to show equivalence. F.i. intra-venious application versus oral.
❝ The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?”
IMHO this is a very sophisticated and nitpicking attitude, suitable to wow NLYW

In the same spirit you can't speak about non-inferiority or superiority studies.
But: "Jedem Tierchen sein Pläsierchen" (rough translation "To each their own"). Especially if it (the beastie) is an assessor.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Reg-Bio Availability or Bio Equivalence study pravin17 2016-05-03 08:07 [Design Issues]
- Bio Availability or Bio Equivalence study Ohlbe 2016-05-03 10:25
- Bio Availability or Bio Equivalence study jag009 2016-05-09 23:09
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- Different rates = BE if intentional (FDA def.) Ohlbe 2016-05-10 22:03
- Different rates = BE if intentional (FDA def.) Helmut 2016-05-10 16:08
- Bio Availability or Bio Equivalence study jag009 2016-05-09 23:09
- Bio Availability or Bio Equivalence study nobody 2016-05-03 10:41
- Bioequivalence study? Helmut 2016-05-03 11:55
- Bioequivalence study? nobody 2016-05-03 14:07
- Bioequivalence study d_labes 2016-05-03 15:50
- Bioequivalence study Helmut 2016-05-03 17:44
- Investigation of ...d_labes 2016-05-04 08:43
- Bioequivalence study Helmut 2016-05-03 17:44
- Bio Availability or Bio Equivalence study Ohlbe 2016-05-03 10:25