Wendy W. Wu

Internal Medicine

110 Irving St NW
Washington, DC 20010

Last Updated: 09/26/2026

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Found 31 publications

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science.

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science.

Journal: Clinical pharmacology and therapeutics

Published: June 02, 2026

Integrating drug effects on individual cardiac ionic currents and cardiac action potentials to understand nonclinical translation to clinical ECG changes.

Integrating drug effects on individual cardiac ionic currents and cardiac action potentials to understand nonclinical translation to clinical ECG changes.

Journal: Frontiers in pharmacology

Published: August 05, 2025

Reassessing the Conduct of Patch Clamp Cardiac Ion Channel Assays to Improve Nonclinical Data Translation to Clinical ECG Changes and Proarrythmia Risk.

Reassessing the Conduct of Patch Clamp Cardiac Ion Channel Assays to Improve Nonclinical Data Translation to Clinical ECG Changes and Proarrythmia Risk.

Journal: Clinical and translational science

Published: July 31, 2025

Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices.

Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices.

Journal: Scientific reports

Published: June 17, 2025

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.

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.

Journal: Analytica chimica acta

Published: November 07, 2024

ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC Studies.

ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC Studies.

Journal: Clinical pharmacology and therapeutics

Published: May 04, 2023

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

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

Journal: Frontiers in medicine

Published: November 27, 2022

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.

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.

Journal: Journal of pharmacological and toxicological methods

Published: May 18, 2022

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.

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.

Journal: PloS one

Published: April 08, 2022

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

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

Journal: Journal of pharmacological and toxicological methods

Published: March 18, 2022

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

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

Journal: Clinical pharmacology and therapeutics

Published: June 16, 2021

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

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

Journal: Clinical pharmacology and therapeutics

Published: December 09, 2020

Showing 1-12 of 31

Last Updated: 09/26/2026