Publications by authors named "Kathi Williams"

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Evaluation of low volume sampling devices for a pharmacodynamic biomarker analysis: Challenges and solutions.
Xiaoyun Yang, Evelin Logis, Kathi Williams, X Rebecca Sheng, Saloumeh K Fischer

J Pharm Biomed Anal· December 2024

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Evaluation of Patient-Centric Sample Collection Technologies for Pharmacokinetic Assessment of Large and Small Molecules.
Sandhya Mandlekar, Dhruvitkumar S Sutaria, Xiaoyun Yang, Ryan Johnson, Yixuan Zou, Kathi Williams

Clin Pharmacol Ther· September 2024

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Validation of low-volume sampling devices for pharmacokinetic analysis: technical and logistical challenges and solutions.
Xiaoyun Yang, Kathi Williams, Rebecca Elliott, Martha Hokom, Janis Allen

Bioanalysis· December 2023

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Kathi Williams

Bioanalysis· August 2023

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Challenges with development of a pharmacokinetics assay to measure a variably glycosylated fusion protein.
Gizette Sperinde, Luna Liu, Keyang Xu, Tracy Bentley, Sid Sukumaran, Kathi Williams

Bioanalysis· January 2022

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Assessment of low volume sampling technologies: utility in nonclinical and clinical studies.
Kathi J Williams, Jeff Lutman, Cynthia McCaughey, Saloumeh K Fischer

Bioanalysis· May 2021

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Evaluation of two point of care technologies for measuring monoclonal antibody therapeutic-A concentrations in blood.
Saloumeh K Fischer, Kathi Williams, Ian Harmon, Bryan Bothwell, Hua Xu

Bioanalysis· October 2020

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Development of an IL-6 point-of-care assay: utility for real-time monitoring and management of cytokine release syndrome and sepsis.
Saloumeh K Fischer, Kathi Williams, Ling Wang, Emmanuel Capio, Mikhail Briman

Bioanalysis· October 2019

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An FcRn- dependent transcytosis assay as a screening tool for predictive assessment of nonspecific clearance of antibody therapeutics in humans.
Shan Chung, Van Nguyen, Yuwen Linda Lin, Julien Lafrance-Vanasse, Suzie J Scales, Kathi Williams

MAbs· July 2019

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Overcoming disease-specific matrix effect in a clinical pharmacokinetic assay using a microfluidic immunoassay technology.
Kathi Williams, Rich Erickson, Saloumeh Kadkhodayan Fischer

Bioanalysis· August 2017

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Automating bioanalytical sample analysis through enhanced system integration.
Vimal Patel, Daniel Leach, Mark Hornberger, Kathi Williams, Judy Shih

Bioanalysis· July 2013

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Analysis of plasmid samples on a microchip.
Li Ding, Kathi Williams, Walter Ausserer, Luc Bousse, Robert Dubrow

Anal Biochem· May 2003

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