## Full Replicate with 3 periods [Design Issues]

Hi mittyri & Achievwin,

Yes and no. The partial replicate was

& & & \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.

—

Helmut Schütz

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]
- 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