ANVISA = EMA’s ABEL! [Regulatives / Guidelines]
As I told you,,....everything can change according a new understanding from ANVISA. But, it is a good news!
About the use of semi or full or replicated, I am encouraged to peform a semi-replicated study with 3-periods because to calculate ISCV, I just need replicate the reference.
Adding: There is no reason to restrict the study only with use of total replicated.
Regards.
Mauricio Sampaio
Edit: two successive messages merged. You can edit your posts within 24 h if needed [Ohlbe]
About the use of semi or full or replicated, I am encouraged to peform a semi-replicated study with 3-periods because to calculate ISCV, I just need replicate the reference.
Adding: There is no reason to restrict the study only with use of total replicated.
Regards.
Mauricio Sampaio
Edit: two successive messages merged. You can edit your posts within 24 h if needed [Ohlbe]
Complete thread:
- ANVISA and replicate designs d_labes 2016-05-11 09:47 [Regulatives / Guidelines]
- ANVISA and replicate designs Mauricio Sampaio 2016-05-18 06:14
- ANVISA and replicate designs earlybird 2016-05-19 16:10
- ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23
- ANVISA = EMA’s ABEL! Lucas 2016-05-19 18:32
- Method A, B (or C?) Helmut 2016-05-19 19:04
- ANVISA = EMA’s ABEL!Mauricio Sampaio 2016-05-19 19:57
- ANVISA = EMA’s ABEL? d_labes 2016-05-24 09:46
- ANVISA = EMA’s ABEL! Lucas 2016-05-19 18:32
- ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23