Different rates = BE if intentional (FDA def.) [Design Issues]
Dear Helmut and John,
On a purely US, regulatory, non-PK point of view, yes
❝ So, given the blue part, John is right.
On a purely US, regulatory, non-PK point of view, yes

—
Regards
Ohlbe
Regards
Ohlbe
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
- Different rates = BE if intentional (FDA def.) Helmut 2016-05-10 16:08
- 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