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Forum time: 2012-02-05
17:21
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Study Performance
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R for BE/BA
Off Topic
Outliers
Conferences / Workshops
Tips / Tricks
Nonparametrics
BE/BA News
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2012 events listing
3rd World Congress on BABE-2012, 26-28 March, Hyderabad
2nd World Congress
Going Off-Topic ♠♣♥♦
Cross-over Trials by Stephen Senn
Conferences / Workshops
HS
2011-10-10 03:15
4
2012-01-16 17:22
1391
Guidance Documents
...other Sources
Requests for Update
Questions for regulatory requirements…
Redesign of FDA's website :-(
Regulatives / Guidelines
HS
2006-01-20 23:28
4
2009-06-08 15:24
24814
anova in BE
General Statistics
AB
2012-02-05 15:21
0
4
BMI vs LIC for age and weight chart
Between subject differences in Xovers
Regulatives / Guidelines
Vardhan82
2012-02-03 06:26
1
2012-02-04 11:30
59
Dissolution of Effervescent Tablets
Dissolution of Effervescent Tablets
Study Performance
joyjac
2012-01-26 03:48
1
2012-02-04 10:58
91
Bioequivalence criteria for endogenous drug
Bioequivalence criteria for endogenous drug
Regulatives / Guidelines
pash413
2012-02-03 12:15
1
2012-02-04 05:31
100
DCGI BE-NOC
DCGI BE-NOC
DCGI BE-NOC
DCGI BE-NOC
DCGI BE-NOC
DCGI BE-NOC
Regulatives / Guidelines
rave04
2012-02-03 06:10
5
2012-02-03 13:19
116
Change in ULOQ concentration
Bioanalytics
auditor
2012-02-03 08:28
0
62
Biosimilars
Biosimilars
Biosimilars
Healthy subjects vs. patients
Biosimilars
Biosimilars
Design Issues
M.Vasu
2011-11-24 14:01
5
2012-02-03 06:43
735
Statistical Out come
Statistical Out come
Statistical Out come
General Statistics
auditor
2012-02-01 12:58
2
2012-02-02 19:13
138
Estimation on Kel, AUCi, Thalf
PK Metrics
MGR
2012-02-02 05:48
0
89
BE of Effervescent Tablets
BE of Effervescent Tablets
Check absorption!
BE of Effervescent Tablets
BE of Effervescent Tablets
BE of Effervescent Tablets
BE of Effervescent Tablets
Study Performance
joyjac
2012-01-12 09:45
6
2012-02-01 04:01
325
clinical trials/ BE studies for locally acting drugs
clinical trials/ BE studies for locally acting drugs
clinical trials/ BE studies for locally acting drugs
Regulatives / Guidelines
jagankm
2012-01-25 11:26
2
2012-01-31 19:01
159
unknown linearity
linear PK required for biowaiver
... or knowledge of non-linearity
... or knowledge of non-linearity
Regulatives / Guidelines
kudra23
2012-01-30 10:30
3
2012-01-31 18:18
156
acceptance criteria of calibration standards
acceptance criteria of calibration standards
acceptance criteria of calibration standards
acceptance criteria of calibration standards
Bioanalytics
haydonat
2012-01-30 14:27
3
2012-01-31 18:05
154
Sample Size Replicated Study
Sample Size Replicated Study
Sample Size Replicated Study
Sample Size Replicated Study
Sample Size Replicated Study
4-treatment-4-period study
4-treatment-4-period study
Clinical study
Power / Sample Size
ashwinim13
2008-08-18 10:42
7
2012-01-31 16:38
2021
SAS and missing values
SAS and missing values
THX & another request
Congratulations for both of us :-D
FDA's RSABE: Phoenix ‘validated’ against SAS
How to obtain CINV value in Phoenix
Import from external source
Thanks, it's done!!
Thanks, it's done!!
SAS and missing values
Software
HS
2012-01-06 01:47
9
2012-01-31 03:12
492
Strength selection
Strength selection
Strength selection
Strength selection
Strength selection
Swiss reference?
Swiss reference?
EU reference!
Design Issues
Paresh
2012-01-27 06:47
7
2012-01-29 03:51
250
EMA - Exclusion of data
EMA - Exclusion of data
EMA - Exclusion of data
LSMeans?
LSMeans?
Regulatives / Guidelines
d_labes
2012-01-24 11:09
4
2012-01-26 13:22
280
Paper on RSABE/ABEL
Paper on RSABE/ABEL
Paper on RSABE/ABEL
Hyslop/Howe
Hyslop/Howe
FARTSSIE on RSABE/ABEL
FARTSSIE on RSABE/ABEL
PowerTOST vs. simulation on ABEL
Power / Sample Size
HS
2012-01-04 15:46
7
2012-01-26 10:44
468
Subject to include in BE protocol (FDA SABE approach)
Regulatives / Guidelines
Shuanghe
2012-01-26 09:44
0
137
SD’s Cτ predictive of MD BE?
PK Metrics
HS
2012-01-24 16:45
0
127
Sample Size Calculation for partial and full replicate study
The power to know - no
The power to know - no
Sample size tables used
Not that easy at all
Regulatives / Guidelines
balakotu
2012-01-24 09:44
4
2012-01-24 13:26
293
Calibration Curve
Duplicate LLOQ and ULOQ
Duplicate LLOQ and ULOQ
Duplicate LLOQ and ULOQ
Duplicate LLOQ and ULOQ
Calibration Curve
Calibration Curve
Calibration Curve
Calibration Curve
Bioanalytics
auditor
2012-01-20 11:15
8
2012-01-22 21:48
319
Expedited Review from IEC in case of change in study design
Expedited Review from IEC in case of change in study design
Expedited Review from IEC in case of change in study design
New trial = new opinion
Sample size: parallel ≠ 2× cross-over!
Expedited Review from IEC in case of change in study design
Expedited Review from IEC in case of change in study design
Regulatives / Guidelines
amatewadi
2012-01-09 12:46
6
2012-01-22 14:26
409
study sample analysis
study sample analysis
Bioanalytics
Falisa_Mustafa
2012-01-20 04:06
1
2012-01-20 13:22
174
Tmax in Partial Replicate Design
Good question!
Good question!
Early exposure (+scaling?)
Tmax in Partial replicate design
Tmax in Partial replicate design
Intra-subject contrast (difference)
Intra-subject contrast (difference)
Nonparametrics
Joshua
2012-01-17 06:59
7
2012-01-20 13:01
371
Design the generic ophthalmic solutions clinical trials
Design the generic ophthalmic solutions clinical trials
Design Issues
gore.lalit
2012-01-20 05:26
1
2012-01-20 08:31
212
FDA enforcing QbD from 2013
FDA enforcing QbD from 2013
Dissolution / BCS/IVIVC
ElMaestro
2012-01-19 15:19
1
2012-01-19 15:48
206
Spiking in plasma more then 5%
Spiking in plasma more then 5%
Bioanalytics
auditor
2012-01-19 08:47
1
2012-01-19 11:19
173
Biowaiver of strengh in fixed combinatios
Regulatives / Guidelines
Averroes
2012-01-18 13:05
0
151
WHO BTIF
WHO BTIF
WHO BTIF
WHO BTIF
WHO BTIF
WHO BTIF
WHO BTIF
Inter- or intra-subject CV?
intrasubject
intrasubject
intrasubject
Regulatives / Guidelines
K2K
2012-01-12 05:15
10
2012-01-18 09:36
460
manual power calculation
manual power calculation: why?
manual power calculation: why?
FARTSSIE.xls
FARTSSIE.xls
CV from CI: manual, PowerTOST, FARTSIE.xls
CV from CI: manual, PowerTOST, FARTSIE.xls
Power / Sample Size
Karthik
2011-03-17 10:17
6
2012-01-18 09:35
1576
Biowaiver Monographs
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Biowaiver Monographs (new FIP link)
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Dodium and the end of world
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Biowaiver Monographs (Update)
Dissolution / BCS/IVIVC
HS
2006-06-02 17:57
13
2012-01-17 17:50
8759
Power for unbalanced cross-over
Great post!
Santa is coming
PowerTOST
BIBDs
Uuups
PowerTOST robust
Power / Sample Size
d_labes
2011-01-14 15:21
6
2012-01-17 11:53
1403
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