Sunday, May 15, 2011

Update on GBC: All Harmonsation Team leads have been assigned

All Molecules / All Techniques

A1 - Scope and Regulations : Surendra Bansal
A2 - Tiered approaches for method validation : Steve Lowes
A3 - Method transfer, partial/cross validations : Ray Briggs
A4 - Reference standards and reagents : Joseph Bower
A5 - Sample Management : Mike Redrup
A6 - Stability : Nico van de Merbel
A7 - Repeat analysis and ISR : Eric Fluhler
A8 - Documentation : Tom Verhaeghe
A9 - Analytical instrument qualification : Chad Briscoe
A10 - New Frontiers : Robert Benthem
A11 - Biomarkers : Howard Hill

Large Molecules / Ligand Binding

L1 - Large molecule specific run acceptance : Marian Kelley
L2 - Large molecule specific assay operation : Lauren Stevenson
L3 - Assay formats : Sherri Dudal
L4 - Reagents and their stability : Lindsay King
L5 - Automation practices in LM bioanalysis : Han Gunn
L6 - Immunogenicity - Effect on PK : Jeff Sailstad

Small Molecules / Chromatographic Assays

S1 - Small molecule specific run acceptance : Doug Fast
S2 - Small molecule specific assay operation : Eric Woolf
S3 - Chromatographic run quality assessment : Stuart McDougall

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