Full Replicate with 3 periods [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2023-03-28 11:03 (451 d 07:18 ago) – Posting: # 23517
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Hi mittyri & Achievwin,

❝ ❝ can [TRT, RTR] be a substitute for RTRT or TRTR, or TTRR or RRTT (in four period fully replicated design)?

❝ Hey! Look at the fresh FDA draft

❝ Bloody partial replicate goes away and is being substituted to that design in GL.


Yes and no. The partial replicate was nowhere mentioned in the previous (2001) guidance. On page 8 (after the 2-sequence 4-period full replicate) we read:

Other replicated crossover designs are possible. For example, a three-period design, as shown below, could be used.

$$\small{\begin{array}{rcccc}
& & & \text{Period}\\\\
& & 1 & 2 & 3\\\\
& 1 & \textbf{T} & \textbf{R} & \textbf{T}\\
\text{Sequence}\\
& 2 & \textbf{R} & \textbf{T} & \textbf{R}
\end{array}}$$ However, the partial replicate (and not the TRT|RTR) is still stated in the ANDA draft

❝ I would opt for it.


So would I. Not at least because of the nasty issues of the partial replicate in A.

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