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Two Stage Desing: ANOVA
Potvin et al: effects in stage 2
Potvin et al: effects in stage 2
Forget simulationbased TSDs for 2×2×2 in Europe
TSD statistical model  with multiple sites
TSD statistical model  with multiple sites
TSD statistical model  with multiple sites
TSD statistical model  with multiple sites
earlybird
20091016 11:25
7
20211012 11:27
7,506
Twostage design Regulatory
EMA: TSDs
Mikkabel
20200623 17:42
1
20200623 18:22
1,222
ANVISA guidelines for twostage design
Brainless copyandpastedevil
Brainless copyandpastedevil
ANVISA guidelines for twostage design
ANVISA guidelines for twostage design
ANVISA guidelines for twostage design
ANVISA guidelines for twostage design
ANVISA guidelines for twostage design
ANVISA guidelines for twostage design
crap
crap
crap
crap
Explained crap remains crap
Proposed changes
Proposed changes
Mauricio Sampaio
20200211 20:52
15
20200217 14:16
5,364
EU, method C preference
On the contrary, my dear Dr. Watson!
On the contrary, my dear Dr. Watson!
On the contrary, my dear Dr. Watson!
On the contrary, my dear Dr. Watson!
On the contrary, my dear Dr. Watson!
On the contrary, my dear Dr. Watson!
EU: simulationbased methods in agony
EU: ABEL TIE??
Referencescaling: only simulations possible
ElMaestro
20191011 10:25
9
20191020 13:58
4,005
Appropriate wording for a protocol
Appropriate wording for a protocol
Appropriate wording for a protocol
Appropriate wording for a protocol
Which country?
Which country?
EEUrules, TSDmethods (lengthy answer)
EEUrules, TSDmethods (lengthy question)
n2 based on PK metric with higher CV
Q&A ref
The omniscient oracle has spoken
The omniscient oracle has spoken
OT: Булга́ков
n2 based on PK metric with higher CV
AUC passes with 0.05 and Cmax with 0.0294
AUC passes with 0.05 and Cmax with 0.0294
Hybrid B/C
AUC passes with 0.05 and Cmax with 0.0294
Use data of all dosed subjects
Use data of all dosed subjects
‘Method C’ ⇒ risky
EEUrules, TSDmethods (lengthy question)
apple tree for twostage
overripe apples
override apples
Elena777
20190909 19:34
24
20190919 16:15
7,429
TwoStage Design for FDC
No simple way out
the more complicated the more interesting
Astea
20190606 01:24
2
20190609 22:56
2,351
2stage design with interim sample size estimation
2stage design with interim sample size estimation
Null = bioINequivalence
2stage design with interim sample size estimation
2stage design with interim sample size estimation
Blind or not, Indecisions or Decisions
Blind or not, Indecisions or Decisions
Blind ?
Blind ?
Blind 2Stage
Blind 2Stage
Blind 2Stage and an elephant
Which elephant?
Blind interim in parallel design?
Blind men
The Blind Leading the Blind
d_labes
20101005 15:09
15
20190606 00:55
13,588
Finally: Exact TSD methods for 2×2 crossover designs
Exact TSD methods: Example
Finally: Exact TSD methods for 2×2 crossover designs
Flow chart (without details)
naive questions regarding new functions in Power2Stage
Some answers
Some more "answers"
clarification regarding user Power2Stage guides
Technicality: Weigths for the inverse normal approach
Selection of w and w*
Selection of w and w*
Now what? w & w* examples
Now what? w & w* examples
Now what? w & w* examples
Now what? w & w* examples
a bug in interim.tsd.in()?
a bug in interim.tsd.in()?
Nonbinding futility rule
Bad weather?
NLYW?
Nonbinding futility rule
Nonbinding futility rule
Nonbinding futility rule
Binding / Nonbinding futility rule  alpha control
Binding / Nonbinding futility rule  alpha control
Helmut
20180421 17:17
24
20190330 09:52
16,290
Twostage design and 'forced bioequivalence'
Twostage design and 'forced bioequivalence'
Twostage design and 'forced bioequivalence'
But what is the real problem?
But what is the real problem?
But what is the real problem?
But what is the real problem?
But what is the real problem?
U as a futility criterion
Mikalai
20180606 08:28
8
20180608 14:00
4,514
Two PK metrics: Inflation of the Type I Error
Two PK metrics: Inflation of the Type I Error?
A place to start
A place to start?
A place to start?
Scientific gut feeling
Five minutes gone  power.tsd.2m() arose
A better place to start.
Nope
Nope
I've meditated hard
Helmut
20171112 11:57
10
20171115 13:15
8,605
Potvin designs w. imbalance  what would you expect?
Dropouts in stage 2
Dropouts continued
ElMaestro
20170817 13:02
2
20170919 17:17
5,797
Initial sample size guess for the Potvin methods
Initial sample size guess for the Potvin methods
Initial sample size guess for the Potvin methods
Initial sample size guess for the Potvin methods
Initial sample size guess for the Potvin methods
ConfuseaCat
ConfuseaCat
loop ↔ vectorized ↔ direct
loop ↔ vectorized ↔ direct
loop ↔ vectorized ↔ direct
loop ↔ vectorized ↔ direct
The n ext crackpot iteration
The n ext crackpot iteration
The ultimate crackpot iteration!
The ultimate crackpot iteration!
The ultimate crackpot iteration!
The ultimate crackpot iteration!
The ultimate crackpot iteration!
The ultimate crackpot iteration!
The ultimate crackpot iteration!
Suggested code
Nitpicker!
Nitpicker!
Nitpicker!
Nitpicker!
Nitpicker!
Benchmark code
Benchmark code
ElMaestro
20170819 15:04
27
20170823 01:48
27,247
Potvin C in the EU
Potvin C in the EU
Potvin C in the EU
2 Groups model FDA
2 Groups model FDA
Group effects obsolete?
Group effects FDA/EMA
Group effects FDA/EMA
Group effects FDA/EMA
Group effects EMA
Group effects EMA
Group effects EMA
Group effects EMA
Group effects EMA
Group effects EMA
Fixed effects model with Group term
Fixed effects model: changing the F, p values
Fixed effects model: changing the F, p values
Fixed effects model: changing the F, p values
Holy War of type III
Significance of Group effect in Russia: why the type III is so 'important'
Fixed effects model: changing the F, p values
FDA group model in R
FDA group model in R
FDA group model in R
FDA group model in R
FDA group model in R
Fixed effects model with Group term
Group effects FDA/EMA
Group effects FDA/EMA
2 Groups model FDA
Homework
Helmut
20130416 17:40
31
20170603 14:57
42,835
Data for 2nd stage of Potvin’s designs
Data for 2nd stage of Potvin’s designs
Data for 2nd stage of Potvin’s designs
GMR = fixed!
“Type 1” slightly higher power than “Type 2” for the same adj. α
“Type 1” slightly higher power than “Type 2” for the same adj. α
Terminology
Terminology
Which GMR to plug in
Which GMR to plug in
Which GMR to plug in
Validated frameworks; observed GMR not relevant
Validated frameworks; observed GMR not relevant
GMR, theta 0 and that all
GMR, theta 0 and that all
GMR, theta 0 and that all
GMR, theta0 and that all
GMR, theta0 and that all
“Type 1” slightly higher power than “Type 2” for the same adj. α
BEproff
20170218 06:40
18
20170309 18:01
12,476
Impact of minimum stage 2 sample size on the Type I Error
Impact of minimum stage 2 sample size on the Type I Error
Impact of minimum stage 2 sample size on the TIE: example
Impact of minimum stage 2 sample size on the TIE: example
Impact of minimum stage 2 sample size on the TIE: example
Impact of minimum stage 2 sample size on the TIE: example
Bingo!
Helmut
20161230 01:22
6
20161230 19:00
5,878
Activity
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