Bioequivalence and Bioavailability Forum • ANVISA = EMA’s ABEL!

ANVISA = EMA’s ABEL! [Regulatives / Guidelines]

posted by Mauricio Sampaio – Brazil, 2016-05-19 21:57 (3231 d 18:54 ago) – Posting: # 16338
Views: 11,408
(edited on 2016-05-20 10:27)

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]

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