CV, not CI [Regulatives / Guidelines]
Hello HS,
I have a question here
Will high intra-subject variability in Clearance and distribution have any role when Parallel design with truncation approach is implemented
Will FDA ask to demonstrate low intra-subject variability in parallel design also


What is the rationale for using intra-subject variability in parallel design approach?
I have a question here
Will high intra-subject variability in Clearance and distribution have any role when Parallel design with truncation approach is implemented

Will FDA ask to demonstrate low intra-subject variability in parallel design also



What is the rationale for using intra-subject variability in parallel design approach?
Complete thread:
- Truncation hiren379 2012-08-14 12:01
- Truncation (FDA: no HVDs) Helmut 2012-08-14 14:18
- Truncation (FDA: no HVDs) hiren379 2012-08-14 14:54
- CV, not CI Helmut 2012-08-14 15:22
- CV, not CIhiren379 2013-12-13 07:53
- CV, not CI Dr_Dan 2013-12-13 09:49
- CV, not CIhiren379 2013-12-13 07:53
- CV, not CI Helmut 2012-08-14 15:22
- Truncation (FDA: no HVDs) hiren379 2012-08-14 14:54
- Truncation (FDA: no HVDs) Helmut 2012-08-14 14:18
