| PHUSE US |
2020 |
FDA and PMDA Study Data Submission Distinctions |
Kiran Kumar Kundarapu |
source poster source |
13 |
| PharmaSUG CN |
2015 |
Summary level clinical site data for data integrity review and inspection planning in NDA and BLA submission [presentation] |
Jingwei Gao |
|
41 |
| PharmaSUG |
2012 |
SDTM Domain Mapping with Structured Programming Methodology |
Chengxin Li, Jing-Wei Gao |
source |
8 |
| SUGI |
1993 |
The Progression and Integration of the CANDA at Merck |
Bruce Binkowitz, Wanda Bidlack |
source |
6 |
| NESUG |
1991 |
The Progression and Integration of the CANDA at Merck |
Wanda Bidlack, Dan Himmel, Bruce Binkowitz |
|
6 |
| SUGI |
1988 |
Designing a Drug Information System for the FDA Based on the SAS System |
|
source |
6 |