Bioequivalence and Bioavailability Forum • Case Study (FDA)

Case Study (FDA) [RSABE / ABEL]

posted by jag009 – NJ, 2014-10-01 22:41 (3877 d 14:37 ago) – Posting: # 13637
Views: 7,925

Hi Luv,

❝ 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
- 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 06:15
    - Case Study (FDA)jag009 2014-10-01 20:41