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15 papers and 2 presentations; 17 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2025 A discussion of the new ADaM guidance (ADNCA and ADPPK) for pharmacokinetics. Luke Reinbolt source 3
PHUSE EU 2020 Guide to Electronic Submission of Pharmacometric Datasets and Analyses to the Regulatory Authorities [presentation] Pooja Kulkarni source
video
17
PHUSE EU 2019 Bioequivalence Testing for Highly Variable Drug Products (HVDPs) James R. Johnson source
presentation source
9
PHUSE US 2018 Methods for Handling Concentration Values Below the Limit of Quantification in PK Studies James R. Johnson source
presentation source
9
PharmaSUG 2018 A CRO's perspective on successful partnering to deliver SDTM/SEND contributions Helen Owen,
Kirsty Payne
source 7
PharmaSUG 2018 Coming soon: ADNCA and the PK submission Luke Reinbolt,
Liz MacDonald
source 6
PHUSE EU 2014 Unuttered Questions of Statistical Programmers Aparajita Dey source
presentation source
10
PHUSE EU 2013 eBESTreports - The Fastest Way to Conclusions [presentation] Tuomas Kemppainen,
Juha Hyssala
source 25
PHUSE EU 2010 BeST - Bioequivalence Study Template Pekka Heikkilä source
presentation source
9
PharmaSUG 2009 Fitting Compartmental Models to Multiple Dose Pharmacokinetic Data using SAS PROC NLMIXED Jing Su,
Peng Sun,
Xiaodong Li,
Alan H. Hartford
9
PHUSE EU 2007 Bootstrapping in a replicative bioequivalence study Feryal Tanriverdio,
Arne Ring
source 11
PharmaSUG 2000 A SAS Tool for the Presentation and Statistical Analysis of Data from Bioavailability and Bioequivalence Studies Melvin S. Munsaka,
Carl R. Haske
8
MWSUG 1999 Sample Size Determination From A Pilot Bioequivalence Study For A Future Pivotal Bioequivalence Study: A SAS Procedure Xiang Gao,
Henry Cheng
7
SEUGI 1994 Model-Independent Pharmacokinetics Using SAS/PH-Kinetics Software Brian Fredric source 5
SEUGI 1991 Confidence Intervals for Bioequivalence Studies B. Jones,
D. J. Nichols,
P. Blood
source 12
SUGI 1989 The Application of Base SAS, SAS/STAT, and SAS/GRAPH Software to the Analysis and Presentation of Pharmacokinetic Data Philip H. Schwartz source 5
SUGI 1982 A Pharmacokinetic Analysis System (PAS) Raymond P. Chen,
Daniel M. Wildman
source

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