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

posted by Helmut Homepage – Vienna, Austria, 2016-05-19 18:23 (2870 d 02:41 ago) – Posting: # 16335
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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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