Michele Malone

Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis

Steve Lowes, Jim Jersey, Ronald E. Shoup et al. · Bioanalysis · 2011 · 88 citations

Global Cro Council, Medicine, Global Health +14

Recommendations on Biomarker Bioanalytical Method Validation By Gcc

Richard Hougton, Dominique Gouty, John Allinson et al. · Bioanalysis · 2012 · 60 citations

Cro Leaders, Engineering, Pathology +19

Recommendations on The Interpretation of The New European Medicines Agency Guideline on Bioanalytical Method Validation By Global Cro Council For Bioanalysis (Gcc)

Mark Boterman, Mira Doig, Massimo Breda et al. · Bioanalysis · 2012 · 44 citations

Global Cro Council, Engineering, Verification And Validation +16

Recommendations on Bioanalytical Method Stability Implications of Co-Administered And Co-Formulated Drugs By Global Cro Council For Bioanalysis (Gcc)

Steve Lowes, Mark Boterman, Mira Doig et al. · Bioanalysis · 2012 · 32 citations

Pharmaceutical Science, Global Cro Council, Co-formulated Drugs +19

8th GCC: Consolidated Feedback to US FDA on The 2013 Draft FDA Guidance on Bioanalytical Method Validation

Joseph Bower, Douglas M. Fast, Fabio Garofolo et al. · Bioanalysis · 2014 · 31 citations

Engineering, Verification And Validation, Consolidated Feedback +16