Wendy Wu

Senior Pharmacokineticist / Principal Investigator / Lab Head

US Food and Drug Administration

United States

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Wendy Wu is a Senior Pharmacokineticist, Principal Investigator, and Lab Head at the U.S. Food and Drug Administration. Her research focuses on pharmacokinetics, particularly in the areas of drug solubility and cardiac safety assessments. Recent publications include work on in vitro hERG assay methodologies and the impact of experimental conditions on drug potency. She contributes to advancing drug regulation and addressing public health issues through scientific innovation.

Articles (10)

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2025

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2023

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2023

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2022

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2022

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2022

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2022

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2021

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2020

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2020

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Nicolas Thiebaud

Vertex Pharmaceuticals

UNITED KINGDOM

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Gary Richard Mirams

Professor of Mathematical Physiology / Wellcome Trust Senior Research Fellow

University of Nottingham

UNITED KINGDOM

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Wendy Wu

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Articles (10)

ACA-24-3995.Highlighted: Determination of Lopinavir and Ritonavir in hERG solution to Support In Vitro hERG Block Potency Assessment Using LC-MS/MS: The Challenge of Poor Drug Solubility

ICH S7B In Vitro Assays Do Not Address Mechanisms of QT<sub>C</sub> Prolongation for Peptides and Proteins – Data in Support of Not Needing Dedicated QT<sub>C</sub> Studies

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Experimental factors that impact CaV1.2 channel pharmacology—Effects of recording temperature, charge carrier, and quantification of drug effects on the step and ramp currents elicited by the “step-step-ramp” voltage protocol

Determination of five positive control drugs in hERG external solution (buffer) by LC-MS/MS to support in vitro hERG assay as recommended by ICH S7B

Expanding Approved Patient Populations for Rare Disease Treatment Using In Vitro Data

hERG block potencies for 5 positive control drugs obtained per ICH E14/S7B Q&As best practices: Impact of recording temperature and drug loss

Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm

A general procedure to select calibration drugs for lab-specific validation and calibration of proarrhythmia risk prediction models: An illustrative example using the CiPA model

Collaborators (2)

Nicolas Thiebaud

Gary Richard Mirams

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Wendy Wu

Research Interests

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About

Articles (10)

ACA-24-3995.Highlighted: Determination of Lopinavir and Ritonavir in hERG solution to Support In Vitro hERG Block Potency Assessment Using LC-MS/MS: The Challenge of Poor Drug Solubility

ICH S7B In Vitro Assays Do Not Address Mechanisms of QT<sub>C</sub> Prolongation for Peptides and Proteins – Data in Support of Not Needing Dedicated QT<sub>C</sub> Studies

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Experimental factors that impact CaV1.2 channel pharmacology—Effects of recording temperature, charge carrier, and quantification of drug effects on the step and ramp currents elicited by the “step-step-ramp” voltage protocol

Determination of five positive control drugs in hERG external solution (buffer) by LC-MS/MS to support in vitro hERG assay as recommended by ICH S7B

Expanding Approved Patient Populations for Rare Disease Treatment Using In Vitro Data

hERG block potencies for 5 positive control drugs obtained per ICH E14/S7B Q&amp;As best practices: Impact of recording temperature and drug loss

Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm

A general procedure to select calibration drugs for lab-specific validation and calibration of proarrhythmia risk prediction models: An illustrative example using the CiPA model

Collaborators (2)

Nicolas Thiebaud

Gary Richard Mirams

Make your next move.

hERG block potencies for 5 positive control drugs obtained per ICH E14/S7B Q&As best practices: Impact of recording temperature and drug loss