Eric Woolf

发表

Issues facing the bioanalytical community: summary of round table discussions.

Neil Spooner, Stephanie Cape, Roger Hayes, 2016, Bioanalysis.

2 Bioanalytical report writing

Kevin Bateman, Roger Hayes, Eric Woolf, 2022 .

Regulated Bioanalysis—Historical Aspects and Key Concepts Related to Its Use

Eric Woolf, Sheila Breidinger, E. Woolf, 2017 .

A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs.

Yang Xu, Eric Woolf, Kun Yang, 2020, ACS pharmacology & translational science.

Recommendations from the Global Bioanalysis Consortium Team A8: Documentation

Eric Woolf, Marian Kelley, Tom Verhaeghe, 2013, The AAPS Journal.

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.

Eric Woolf, Surendra Bansal, Mohammed Jemal, 2010, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Lindsay King, Roger Hayes, Surinder Kaur, 2014, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Lindsay King, Stacy Ho, Roger Hayes, 2014, Bioanalysis.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).

Roger Hayes, Amanda Wilson, Eric Woolf, 2015, Bioanalysis.

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Stacy Ho, Eric Woolf, Binodh DeSilva, 2011, Bioanalysis.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

Stacy Ho, Roger Hayes, Eric Woolf, 2013, Bioanalysis.

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

Stephanie Cape, Scott Summerfield, Amanda Wilson, 2016, Bioanalysis.

Single-Dose Pharmacokinetics of Indinavir and the Effect of Food

Eric Woolf, Andrew T. Sterrett, Michael Hesney, 1998, Antimicrobial Agents and Chemotherapy.

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

Hao Jiang, Amanda Wilson, Eric Woolf, 2017, Bioanalysis.

Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation.

Eric Woolf, Philip Timmerman, Surendra Bansal, 2010, Bioanalysis.

Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples

Eric Woolf, W. Nowatzke, E. Woolf, 2007, The AAPS Journal.

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Eric Woolf, Binodh DeSilva, Lauren Stevenson, 2014, The AAPS Journal.

Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group

Eric Woolf, Philip Timmerman, Wenkui Li, 2014, The AAPS Journal.

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Eric Woolf, Akiko Ishii-Watabe, Naidong Weng, 2018, Bioanalysis.