|
Multiple Standardized Units requested by sponsor
|
|
2
|
10
|
December 11, 2014
|
|
Rule SD0063 issue
|
|
1
|
9
|
December 10, 2014
|
|
Java API for reading SAS XPT file
|
|
4
|
2
|
December 10, 2014
|
|
ODM Validation
|
|
5
|
15
|
December 10, 2014
|
|
SD1202, SD1203, SD1204 (date after RFPENDTC) not addressed in FDA's validation checks
|
|
3
|
16
|
December 10, 2014
|
|
Modelling Error 3
|
|
3
|
6051
|
December 9, 2014
|
|
missing Deconvolution dosing
|
|
2
|
9774
|
December 8, 2014
|
|
SUBJECT by FORMULATION INTERACTION RSABE
|
|
0
|
5714
|
December 8, 2014
|
|
Clumsy replace
|
|
4
|
6442
|
December 6, 2014
|
|
AD0083 and AD0084, TRTSDT and TRTEDT comparison with periods of treatment
|
|
1
|
21
|
December 2, 2014
|
|
OD0006
|
|
2
|
6
|
December 2, 2014
|
|
Zero Order absorption
|
|
1
|
11542
|
November 25, 2014
|
|
TIP: How to find the Example Guide for Phoenix WinNonlin?
|
|
0
|
8497
|
November 21, 2014
|
|
How to calculate (cumulative) amount excreted in Phoenix WNL 6.3 ?
|
|
3
|
6562
|
November 21, 2014
|
|
Deconvultion Method - Phoenix WinNonlin 6.3
|
|
3
|
8639
|
November 20, 2014
|
|
FDA Publishes Official Validation Rules for Submission Data
|
|
0
|
5
|
November 18, 2014
|
|
In vivo data set not available for 2 formulation
|
|
4
|
9472
|
November 18, 2014
|
|
Parallel Computing
|
|
0
|
5526
|
November 17, 2014
|
|
DD0024 rule mis-firing?
|
|
1
|
3
|
November 17, 2014
|
|
methylphenidate BIOEQUIVALENCE
|
|
1
|
5730
|
November 14, 2014
|
|
Confusing step on Phoenix 1.4, Data Wizard>Properties
|
|
0
|
5349
|
November 14, 2014
|
|
OpenCDISC Validator 1.4.1 - User Define Formats
|
|
3
|
9
|
November 10, 2014
|
|
Template: Tables Font default change
|
|
3
|
6624
|
November 10, 2014
|
|
Running BE simulation for infusion modelled drug
|
|
0
|
4491
|
November 7, 2014
|
|
PHOENIX MODEL FEATURE FOR simulation at specified times
|
|
3
|
4888
|
November 6, 2014
|
|
MUTIPLE DOSE SIMULATION WITH PHOENIX MODEL
|
|
12
|
7877
|
November 5, 2014
|
|
CT0169 & CT0170 error in OpenCDISC QSTESTCD and QSTEST are not in CT 'BARS'
|
|
3
|
13
|
November 4, 2014
|
|
Bug in config-sdtm-3.2.xml
|
|
1
|
4
|
October 31, 2014
|
|
Problem in the Excel Report
|
|
1
|
4
|
October 31, 2014
|
|
CT0081 and CT0081R false positives on SPONSOR/Clinical Study Sponsor
|
|
5
|
8
|
October 30, 2014
|