2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.
Algorithme Pharma Inc., 575 Armand-Frappier Blvd, Laval (Montreal), Quebec, Canada.
Natasha
N
Savoie
Fabio
F
Garofolo
Peter
P
van Amsterdam
Surendra
S
Bansal
Chris
C
Beaver
Patrick
P
Bedford
Brian P
BP
Booth
Christopher
C
Evans
Mohammed
M
Jemal
Marc
M
Lefebvre
Arthur Leonardo
AL
Lopes de Silva
Steve
S
Lowes
Joseph C
JC
Marini
Robert
R
Massé
Louise
L
Mawer
Eric
E
Ormsby
Mario L
ML
Rocci
Ct
C
Viswanathan
Jason
J
Wakelin-Smith
Jan
J
Welink
Joleen T
JT
White
Eric
E
Woolf
D001702:Biopharmaceutics / Q000379:methods* / Q000592:standards; D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D011792:Quebec
D004364:Pharmaceutical Preparations