Mike Buonarati

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

Pharmacy, Toxicology, Analytical Chemistry +13

Recommendations on Biomarker Bioanalytical Method Validation By Gcc

Richard Hougton, Dominique Gouty, John Allinson et al. · Bioanalysis · 2012 · 61 citations

Pharmacy, Biomedical Sciences, Analytical Chemistry +14

Recommendations on Incurred Sample Stability (ISS) by GCC

Steve Lowes, Richard LeLacheur, Ronald E. Shoup et al. · Bioanalysis · 2014 · 34 citations

Pharmacy, Chemistry, Analytical Chemistry +16

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

Pharmacy, Biomedical Sciences, Drug Approval Processes +14

7th GCC Insights: Incurred Samples Use; Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing

Mario L. Rocci, Steve Lowes, Ronald E. Shoup et al. · Bioanalysis · 2014 · 19 citations

Pharmacy, Chemistry, Analytical Chemistry +16