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Hi Luv,
Not big, less than 20%, maybe like 15%? It was diltiazem. Basically we started the project with DR (or ER) beads in a capsule formulation but then switched to a tablet formulation containing the same ER beads (We called it a wax tablet). It was dead on bioequivalence with T/R Ratio like 95-99%.
John
❝ What was the ISCV observed?
❝ In one of our current study of DR pellets we got IntraSCV ~110% for reference and test (T/R min and max ranges was 8%-4000%) where as the interSCV was ~100% for both.
Not big, less than 20%, maybe like 15%? It was diltiazem. Basically we started the project with DR (or ER) beads in a capsule formulation but then switched to a tablet formulation containing the same ER beads (We called it a wax tablet). It was dead on bioequivalence with T/R Ratio like 95-99%.
John
Complete thread:
- Case Study (FDA) Helmut 2014-09-30 13:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Case Study (FDA) jag009 2014-09-30 17:25
- Case Study (FDA) Helmut 2014-09-30 20:09
- Case Study (FDA) luvblooms 2014-10-01 06:24
- Case Study (FDA) Helmut 2014-10-01 14:32
- Case Study (FDA) luvblooms 2014-10-01 06:24
- Case Study (FDA) luvblooms 2014-10-01 06:15
- Case Study (FDA)jag009 2014-10-01 20:41
- Case Study (FDA) Helmut 2014-09-30 20:09
- Case Study (FDA) jag009 2014-09-30 17:25
Ing. Helmut Schütz