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RegisterFull Replicate with 3 periods [Design Issues]
posted by Helmut 
– Vienna, Austria, 2023-03-28 11:03 (622 d 17:55 ago) – Posting: # 23517
Views: 3,988
Hi mittyri & Achievwin,
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:
& & & \text{Period}\\\\
& & 1 & 2 & 3\\\\
& 1 & \textbf{T} & \textbf{R} & \textbf{T}\\
\text{Sequence}\\
& 2 & \textbf{R} & \textbf{T} & \textbf{R}
\end{array}}$$ However, the partial replicate (and not the TRT|RTR) is still stated in the ANDA draft…
So would I. Not at least because of the nasty issues of the partial replicate in A.
❝ ❝ can [TRT, RTR] be a substitute for RTRT or TRTR, or TTRR or RRTT (in four period fully replicated design)?
❝ Hey! Look at the fresh FDA draft
❝ Bloody partial replicate goes away and is being substituted to that design in GL.
Yes and no. The partial replicate was nowhere mentioned in the previous (2001) guidance. On page 8 (after the 2-sequence 4-period full replicate) we read:
Other replicated crossover designs are possible. For example, a three-period design, as shown below, could be used.
$$\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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Definition of Full Replicate Sereng 2023-03-13 17:08 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Definition of Full Replicate Mahmoud 2023-03-13 20:27
- Definition of Full Replicate Sereng 2023-03-13 23:38
- Definition of Full Replicate Mahmoud 2023-03-14 08:44
- Definition of Full Replicate Achievwin 2023-03-27 19:08
- Full Replicate with 3 periods mittyri 2023-03-27 22:16
- Full Replicate with 3 periods Achievwin 2023-03-28 03:06
- Full Replicate with 3 periodsHelmut 2023-03-28 09:03
- Full Replicate with 3 periods mittyri 2023-03-27 22:16
- Definition of Full Replicate Achievwin 2023-03-27 19:08
- Definition of Full Replicate Mahmoud 2023-03-14 08:44
- Definition of Full Replicate Sereng 2023-03-13 23:38
- Definition of Full Replicate Brus 2023-03-14 10:10
- Replicate Design ≠ Higher-Order Crossover Helmut 2023-03-14 10:37
- Thank You! Sereng 2023-03-14 20:08
- Replicate Design ≠ Higher-Order Crossover Relaxation 2023-03-20 08:56
- imbalance in Latin Square mittyri 2023-03-27 23:01
- Balance for all effects Helmut 2023-04-21 10:01
- Definition of Full Replicate Mahmoud 2023-03-13 20:27
Ing. Helmut Schütz