E. Woolf

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Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Teams

Hollie H. Barton, C. Holliman, E. Woolf, 2014, The AAPS Journal.

Effect of alendronate and vitamin D3 on fractional calcium absorption in a double‐blind, randomized, placebo‐controlled trial in postmenopausal osteoporotic women

S. Shapses, R. Sherrell, E. Woolf, 2011, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).

Sam H Haidar, Gustavo Mendes Lima Santos, Nicola C Hughes, 2018, Bioanalysis.

Novel Application of the Two‐Period Microtracer Approach to Determine Absolute Oral Bioavailability and Fraction Absorbed of Ertugliflozin

D. Papadopoulos, A. Vaz, V. Sahasrabudhe, 2018, Clinical and translational science.

Quantitation of anacetrapib, stable-isotope labeled-anacetrapib (microdose), and four metabolites in human plasma using liquid chromatography tandem mass spectrometry.

R. W. Lutz, K. Bateman, E. Woolf, 2016, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Toward highly sensitive and reproducible LC-MS/MS analysis of MK-8591 phosphorylated anabolites in human peripheral blood mononuclear cells.

Rena Zhang, Suzie Yeh, E. Woolf, 2019, Bioanalysis.

Development and validation of a selective and sensitive bioanalytical procedure for the quantitative determination of gaboxadol in human plasma employing mixed mode solid phase extraction and hydrophilic interaction liquid chromatography with tandem mass spectroscopic detection.

E. Woolf, M. Kall, Tina Dige, 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Insulin glargine and its two active metabolites: A sensitive (16pM) and robust simultaneous hybrid assay coupling immunoaffinity purification with LC-MS/MS to support biosimilar clinical studies.

K. Bateman, E. Woolf, Li Sun, 2017, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Single-Dose Pharmacokinetics of Indinavir and the Effect of Food

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

Determination of L-735 524, an human immunodeficiency virus protease inhibitor, in human plasma and urine via high-performance liquid chromatography with column switching.

E. Woolf, B. Matuszewski, H. Haddix, 1995, Journal of chromatography. A.

Bioequivalence of Alendronate and Vitamin D3 in a Combination Tablet Versus Corresponding-Dose Individual Tablets in Healthy Taiwanese Volunteers, Determined Using a Novel Plasma Alendronate Assay

E. Woolf, L. Hickey, G. Yeh, 2015, Current therapeutic research, clinical and experimental.

Determination of fexofenadine in human plasma using 96-well solid phase extraction and HPLC with tandem mass spectrometric detection.

E. Woolf, B. Matuszewski, I. Fu, 2004, Journal of pharmaceutical and biomedical analysis.

Strategy for peptide quantification using LC-MS in regulated bioanalysis: case study with a glucose-responsive insulin.

E. Woolf, D. Goykhman, Iris Xie, 2018, Bioanalysis.

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Sam H Haidar, Lauren F. Stevenson, Lauren F Stevenson, 2012, Bioanalysis.

Bioavailability of Alendronate and Vitamin D3 in an Alendronate/Vitamin D3 Combination Tablet

R. Ramakrishnan, J. Wagner, E. Woolf, 2011, Journal of clinical pharmacology.

Effect of the sample matrix on the determination of indinavir in human urine by HPLC with turbo ion spray tandem mass spectrometric detection.

E. Woolf, B. Matuszewski, I. Fu, 1998, Journal of pharmaceutical and biomedical analysis.

Indinavir and Rifabutin Drug Interactions in Healthy Volunteers

S. Waldman, P. Deutsch, W. Kraft, 2004, Journal of clinical pharmacology.

Determination of Doravirine in human plasma using liquid-liquid extraction and HPLC-MS/MS.

E. Woolf, D. Goykhman, R. Desai, 2019, Bioanalysis.

Evaluation of dried blood spot (DBS) technology versus plasma analysis for the determination of MK-1775 by HILIC-MS/MS in support of clinical studies

W. Zeng, S. Leijen, E. Woolf, 2012, Analytical and Bioanalytical Chemistry.

A flexible and high throughput liquid chromatography-tandem mass spectrometric assay for the quantitation of telcagepant in human plasma.

E. Woolf, C. Miller-Stein, Lihong Du, 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Determination of rofecoxib, a cyclooxygenase-2 specific inhibitor, in human plasma using high-performance liquid chromatography with post-column photochemical derivatization and fluorescence detection.

E. Woolf, B. Matuszewski, I. Fu, 1999, Journal of chromatography. B, Biomedical sciences and applications.

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).

Sam H Haidar, Olivier Le Blaye, Gustavo Mendes Lima Santos, 2017, Bioanalysis.

Volumetric absorptive microsampling (VAMS®) in therapeutic protein quantification by LC-MS/MS: Investigation of anticoagulant impact on assay performance and recommendations for best practices in method development.

K. Bateman, E. Woolf, S. Shi, 2021, Journal of pharmaceutical and biomedical analysis.

Elimination of diastereomer interference to determine Telcagepant (MK-0974) in human plasma using on-line turbulent-flow technology and off-line solid-phase extraction coupled with liquid chromatography/tandem mass spectrometry.

E. Woolf, D. Musson, C. Miller-Stein, 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Simultaneous determination of unlabeled and deuterium-labeled indinavir in human plasma by high-performance liquid chromatography with tandem mass spectrometric detection.

E. Woolf, B. Matuszewski, 1997, Journal of pharmaceutical sciences.

Quantitative determination of odanacatib in human plasma using liquid-liquid extraction followed by liquid chromatography-tandem mass spectrometry analysis.

E. Woolf, Li Sun, S. Breidinger, 2012, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Hydrophilic interaction chromatography/tandem mass spectrometry for the simultaneous determination of three polar non-structurally related compounds, imipenem, cilastatin and an investigational beta-lactamase inhibitor, MK-4698, in biological matrices.

E. Woolf, C. Miller-Stein, W. Xie, 2009, Rapid communications in mass spectrometry : RCM.

Determination of a novel gamma-secretase inhibitor in human plasma and cerebrospinal fluid using automated 96 well solid phase extraction and liquid chromatography/tandem mass spectrometry.

C. Matthews, E. Woolf, 2008, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Determination of dextromethorphan and its metabolite dextrorphan in human urine using high performance liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry: a study of selectivity of a tandem mass spectrometric assay.

E. Woolf, B. Matuszewski, M. Constanzer, 2005, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

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.

Disposition of indinavir, a potent HIV-1 protease inhibitor, after an oral dose in humans.

P. Deutsch, J. Lin, E. Woolf, 1996, Drug metabolism and disposition: the biological fate of chemicals.

Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS.

E. Woolf, B. Matuszewski, L. Wenning, 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Determination of sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometry.

W. Zeng, E. Woolf, D. Musson, 2008, Journal of pharmaceutical and biomedical analysis.

High-throughput, semi-automated determination of a cyclooxygenase II inhibitor in human plasma and urine using solid-phase extraction in the 96-well format and high-performance liquid chromatography with post-column photochemical derivatization-fluorescence detection.

C. Matthews, E. Woolf, B. Matuszewski, 2001, Journal of chromatography. B, Biomedical sciences and applications.

Improved procedure for the the determination of rofecoxib in human plasma involving 96-well solid-phase extraction and fluorescence detection.

C. Matthews, E. Woolf, B. Matuszewski, 2002, Journal of chromatography. A.

Simultaneous determination of unlabeled and carbon-13-labeled etoricoxib, a new cyclooxygenase-2 inhibitor, in human plasma using HPLC-MS/MS.

E. Woolf, B. Matuszewski, M. Rose, 2002, Journal of pharmaceutical sciences.

Determination of pilocarpic acid in human plasma by capillary gas chromatography with mass-selective detection.

E. Woolf, B. Matuszewski, D. Musson, 1998, Journal of chromatography. B, Biomedical sciences and applications.

In-vitro metabolism of celecoxib, a cyclooxygenase-2 inhibitor, by allelic variant forms of human liver microsomal cytochrome P450 2C9: correlation with CYP2C9 genotype and in-vivo pharmacokinetics.

A. D. Rodrigues, C. Tang, T. Rushmore, 2001, Pharmacogenetics.

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.

Optimization of multidimensional high-performance liquid chromatography for the determination of drugs in plasma by direct injection, micellar cleanup and photodiode array detection.

E. Woolf, R. Weinberger, J. Posluszny, 1990, Journal of chromatography.

CHAPTER 8 – POST-COLUMN DERIVATIZATION TECHNIQUES

E. Woolf, 1993 .

Determination of sitagliptinin human plasma using protein precipitation and tandem mass spectrometry.

Eric J Woolf, W. Zeng, E. Woolf, 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Simultaneous investigation of indinavir nonlinear pharmacokinetics and bioavailability in healthy volunteers using stable isotope labeling technique: study design and model-independent data analysis.

P. Rolan, E. Woolf, J. Stone, 1999, Journal of pharmaceutical sciences.

The simultaneous determination of L-697, 661, a HIV-1 specific reverse transcriptase inhibitor, and its 6-hydroxy metabolite in human plasma via column-switching high performance liquid chromatography

E. Woolf, B. Matuszewski, T. Au, 1994 .

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

Lauren F. Stevenson, Sam H. Haidar, B. Desilva, 2015, The AAPS Journal.

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

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

Ultrasensitive liquid chromatography-tandem mass spectrometric methodologies for quantification of five HIV-1 integrase inhibitors in plasma for a microdose clinical trial.

Sheila Breidinger, Eric J Woolf, Larissa Wenning, 2012, Analytical chemistry.

A device for dried blood microsampling in quantitative bioanalysis: overcoming the issues associated blood hematocrit.

E. Woolf, N. Spooner, R. de Vries, 2015, Bioanalysis.

Clinical application of volumetric absorptive microsampling to the gefapixant development program.

K. Bateman, E. Woolf, F. Vazvaei, 2020, Bioanalysis.

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.

Absorption, metabolism, and excretion of etoricoxib, a potent and selective cyclooxygenase-2 inhibitor, in healthy male volunteers.

A. D. Rodrigues, C. Matthews, K. Lasseter, 2003, Drug metabolism and disposition: the biological fate of chemicals.

Direct comparison of radioimmunoassay and LC-MS/MS for PK assessment of insulin glargine in clinical development.

Kevin Bateman, Eric J Woolf, K. Bateman, 2014, Bioanalysis.

Determination of celecoxib in human plasma by normal-phase high-performance liquid chromatography with column switching and ultraviolet absorbance detection.

E. Woolf, B. Matuszewski, M. Rose, 2000, Journal of chromatography. B, Biomedical sciences and applications.

Determination of risedronate in human urine by column-switching ion-pair high-performance liquid chromatography with ultraviolet detection.

E. Woolf, B. Matuszewski, S. Shugarts, 2003, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Merck's perspective on the implementation of dried blood spot technology in clinical drug development - why, when and how.

Yang Xu, Eric J Woolf, Nancy Gb Agrawal, 2013, Bioanalysis.

Simultaneous determination of omeprazole and 5'-hydroxyomeprazole in human plasma by liquid chromatography-tandem mass spectrometry.

E. Woolf, B. Matuszewski, 1998, Journal of chromatography. A.

Assessment of the in-vivo stereochemical integrity of aprepitant based on the analysis of human plasma samples via high-performance liquid chromatography with mass spectrometric detection.

E. Woolf, B. Matuszewski, W. Kline, 2005, Biomedical chromatography : BMC.

The Effects of Modifying In Vivo Cytochrome P450 3A (CYP3A) Activity on Etoricoxib Pharmacokinetics and of Etoricoxib Administration on CYP3A Activity

A. Gottlieb, S. Waldman, W. Kraft, 2004, Journal of clinical pharmacology.

Pharmacokinetics of Etoricoxib in Patients with Hepatic Impairment

C. Matthews, K. Lasseter, E. Woolf, 2003, Journal of clinical pharmacology.

Single‐ and Multiple‐Dose Pharmacokinetics of Etoricoxib, a Selective Inhibitor of Cyclooxygenase‐2, in Man

C. Matthews, K. Lasseter, J. McCrea, 2003, Journal of clinical pharmacology.

Dose Proportionality of Oral Etoricoxib, a Highly Selective Cyclooxygenase‐2 Inhibitor, in Healthy Volunteers

C. Matthews, E. Woolf, K. Gottesdiener, 2001, Journal of clinical pharmacology.

Immunoaffinity purification using anti-PEG antibody followed by two-dimensional liquid chromatography/tandem mass spectrometry for the quantification of a PEGylated therapeutic peptide in human plasma.

E. Woolf, R. Bakhtiar, Yang Xu, 2010, Analytical chemistry.

Single-Dose Pharmacokinetics of Indinavir and the Effect of Food

A. Sterrett, S. Waldman, P. Deutsch, 1998, Antimicrobial Agents and Chemotherapy.

Extractability‐mediated stability bias and hematocrit impact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulated bioanalysis

K. Bateman, E. Woolf, D. Goykhman, 2018, Journal of pharmaceutical and biomedical analysis.

An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs

K. Bateman, P. Kothare, E. Woolf, 2016, The AAPS Journal.

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

T. Olah, P. Timmerman, E. Woolf, 2015, The AAPS Journal.

An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs

K. Bateman, P. Kothare, E. Woolf, 2016, The AAPS Journal.

Effect of disease state on ionization during bioanalysis of MK-7009, a selective HCV NS3/NS4 protease inhibitor, in human plasma and human Tween-treated urine by high-performance liquid chromatography with tandem mass spectrometric detection.

E. Woolf, E J Woolf, M D G Anderson, 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

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.

Determination of an investigational HIV integrase inhibitor in human plasma using high performance liquid chromatography with tandem mass spectrometric detection.

E. Woolf, B. Matuszewski, P. Vallano, 2005, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

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

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

Determination of MK-507, a novel topically effective carbonic anhydrase inhibitor, and its de-ethylated metabolite in human whole blood, plasma, and urine by high-performance liquid chromatography.

E. Woolf, B. Matuszewski, M. Constanzer, 1994, Journal of chromatography. B, Biomedical applications.

Normal-phase high-performance liquid chromatographic procedure for the determination of diprafenone in plasma.

E. Woolf, T. Koziol, D. Austin, 1990, Journal of Chromatography A.

Determination of efavirenz, a selective non-nucleoside reverse transcriptase inhibitor, in human plasma using HPLC with post-column photochemical derivatization and fluorescence detection.

C. Matthews, E. Woolf, B. Matuszewski, 2002, Journal of pharmaceutical and biomedical analysis.

Determination of an in vivo metabolite of a human immunodeficiency virus protease-inhibitor in human plasma by high-performance liquid chromatography with tandem mass spectrometry.

E. Woolf, B. Matuszewski, H. Haddix, 1997, Journal of chromatography. A.

High-performance liquid chromatographic procedure for the determination of a non-nucleoside HIV-1 reverse transcriptase inhibitor in human plasma.

E. Woolf, B. Matuszewski, 1992, Journal of chromatography.

Determination of a macrolide immunosuppressant indolyl-ascomycin derivative in plasma by high performance liquid chromatography with fluorescence detection

E. Woolf, B. Matuszewski, I. Fu, 1999 .

Development of high performance liquid chromatography tandem mass spectrometric methods for the determination of a novel ascomycin-based immunoregulant in human whole blood and plasma: A case of potential analyte loss during sample collection

E. Woolf, B. Matuszewski, B. Karanam, 2002 .

The disposition and metabolism of rofecoxib, a potent and selective cyclooxygenase-2 inhibitor, in human subjects.

T. Baillie, M. Davis, C. Matthews, 2002, Drug metabolism and disposition: the biological fate of chemicals.

Monolithic silica liquid chromatography columns for the determination of cyclooxygenase II inhibitors in human plasma.

E. Woolf, B. Matuszewski, R. Mazenko, 2002, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

SAMPLE PREPARATION VIA SOLID PHASE EXTRACTION IN THE 96-WELL FORMAT FOR HPLC/UV DETECTION-BASED BIOFLUID ASSAYS. APPLICATION TO THE DETERMINATION OF A NOVEL CYCLOOXYGENASE II INHIBITOR IN HUMAN PLASMA AND URINE

E. Woolf, B. Matuszewski, R. Mazenko, 2001 .

Determination of suvorexant in human plasma using 96-well liquid-liquid extraction and HPLC with tandem mass spectrometric detection.

E. Woolf, S. Breidinger, R. Simpson, 2015, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Isolation and structural characterization of the photolysis products of etoricoxib.

C. Matthews, E. Woolf, B. Matuszewski, 2004, Pharmazie.

Pharmacokinetics of Etoricoxib in Patients with Renal Impairment

S. Swan, C. Matthews, T. Marbury, 2004, Journal of clinical pharmacology.

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

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

An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat

K. Bateman, S. Ren, I. Mcintosh, 2022, The AAPS Journal.

A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials

E. Woolf, J. Stone, D. Jaworowicz, 2022, The AAPS Journal.

Elimination of autosampler carryover in a bioanalytical HPLC-MS/MS method: a case study.

E. Woolf, B. Matuszewski, S. Shugarts, 2005, Journal of pharmaceutical and biomedical analysis.

Incorporating protein precipitation to resolve hybrid IP-LC-MS assay interference for ultrasensitive quantification of intact therapeutic insulin dimer in human plasma.

E. Woolf, Li Sun, S. Stoch, 2022, Journal of pharmaceutical and biomedical analysis.

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.

High-throughput simultaneous determination of the HIV protease inhibitors indinavir and L-756423 in human plasma using semi-automated 96-well solid phase extraction and LC-MS/MS.

G. Gatto, M. Braun, E. Woolf, 2000, Journal of pharmaceutical and biomedical analysis.

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

P. Timmerman, E. Woolf, D. Fast, 2010, Bioanalysis.

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

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

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.

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 1--small molecules by LCMS).

Li Xue, Stacy Ho, Neil Spooner, 2014, Bioanalysis.

Ultrasensitive liquid chromatography-tandem mass spectrometric methodologies for quantification of five HIV-1 integrase inhibitors in plasma for a microdose clinical trial.

M. Rizk, E. Woolf, Li Sun, 2012, Analytical chemistry.