Effects and adverse effects [Design Issues]
BE-proff,
for effects and adverse effects ask your physician or pharmacist. See f.i. this presentation. Some more:
for effects and adverse effects ask your physician or pharmacist. See f.i. this presentation. Some more:
- 2×2×3 Full replicate design (RTR|TRT)
- Estimation of CVwR and CVwT.
Suitable for both ABEL (EMA) / RSABE (FDA) and ABE.
Less sampled blood volume compared to RTRT|TRTR and lower chance of dropouts.
- The EMA requires ≥12 evaluable subjects in sequence RTR. Practically not relevant (see this post).
- 2×3×3 Partial replicate design (RRT|RTR|TRR)
- Suitable for both ABEL (EMA) / RSABE (FDA) and ABE.
Less sampled blood volume compared to RTRT|TRTR and lower chance of dropouts.
- Allows only estimation of CVwR.
Sometimes convergence issues if evaluated by FDA’s method for ABE.
- 2×4×2 Balaam’s design (RT|TR|RR|TT)
- Allows estimation of CVwR and CVwT.
Suitable for both ABEL (EMA) / RSABE (FDA) and ABE.
Less sampled blood volume compared to 3-period replicate designs and lower chance of dropouts. - Very (!) low power compared to 3- and 4-period replicate designs. Only ½ of the subjects are used to assess BE; CVwR and CVwT are estimated from ¼ of the subjects.
- Balanced Incomplete Block Designs (BIBD)
- Suitable for ABE.
Generally only used in pilot or dose proportionality studies if >4 treatments are tested and >4 periods cannot be used due to blood volume restrictions and/or expected dropout-rate.
Number of periods < number of treatments.
- Lower power compared to higher-order crossovers (Latin Squares or William’s designs, where number of periods = number of treatments).
- Balaam’s design and the 4-sequence 4-period replicate designs (2×4×2 RTTR|TRRT|RRTT|TTRR) are currently (v1.2-08 of 2015-07-10) not implemented in
PowerTOST
’s functions for ABEL and RSABE.
- The completely randomized 4-period replicate (RTTR|TRRT|RRTT|TTRR|RTRT|TRTR) is not implemented at all. Doesn’t matter – haven’t seen one in ages.
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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
Complete thread:
- Indications for different BE-designs BE-proff 2015-08-17 11:59 [Design Issues]
- Effects and adverse effectsHelmut 2015-08-17 14:55
- Effects and adverse effects BE-proff 2015-08-18 08:26
- Effects and adverse effectsHelmut 2015-08-17 14:55