Full Replicate with 3 periods [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2023-03-28 11:03 (422 d 19:54 ago) – Posting: # 23517
Views: 2,650

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,035 posts in 4,835 threads, 1,645 registered users;
51 visitors (0 registered, 51 guests [including 5 identified bots]).
Forum time: 06:57 CEST (Europe/Vienna)

The mediocre teacher tells.
The good teacher explains.
The superior teacher demonstrates.
The great teacher inspires.    William Arthur Ward

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5