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

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

posted by Helmut – Vienna, Austria, 2016-05-19 18:23 (3231 d 23:51 ago) – Posting: # 16335
Views: 11,562

Hi earlybird,

that’s a fine piece of cake! We have to change the code of the next release of PowerTOST.
@Detlew: Only ANOVA also in Section 1.j) of the current RESOLUÇÃO – RE Nº 1.170, DE 19 DE ABRIL DE 2006

❝ The correct study design for this case is the full replicate design, i.e. a 4-period design.

The WHO’s Working Document does not specify which replicate designs are acceptable (contrary to the EMA mentioning 3- and 4-period replicates). IMHO, the 4-period replicate is the best design anyway…

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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