Andrea Greiter-Wilke
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Explore the profile of Andrea Greiter-Wilke including associated specialties, affiliations and a list of published articles.
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24
Citations
230
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Recent Articles
1.
Boulay E, Authier S, Bartko T, Greiter-Wilke A, Leishman D, Li D, et al.
J Pharmacol Toxicol Methods
. 2024 Jul;
129:107543.
PMID: 39019200
Introduction: Corrected QT interval (QTc)is an established biomarker for drug-induced Torsade de Pointe (TdP), but with concerns for a false positive signal. Clinically, JTpc and TpTec have emerged as ECG...
2.
Harde E, Hierl M, Weber M, Waiz D, Wyler R, Wach J, et al.
Cell Chem Biol
. 2023 Dec;
31(3):577-592.e23.
PMID: 38042151
Hyperpolarization-activated and cyclic-nucleotide-gated 1 (HCN1) ion channels are proposed to be critical for cognitive function through regulation of synaptic integration. However, resolving the precise role of HCN1 in neurophysiology and...
3.
Rossman E, Wisialowski T, Vargas H, Valentin J, Rolf M, Roche B, et al.
J Pharmacol Toxicol Methods
. 2023 May;
123:107270.
PMID: 37164235
The ICH E14/S7B Questions and Answers (Q&As) guideline introduces the concept of a "double negative" nonclinical scenario (negative hERG assay and negative in vivo QTc study) to demonstrate that a...
4.
Bopst M, Dinklo T, Funk J, Greiter-Wilke A, Lenz B, Kustermann S, et al.
Regul Toxicol Pharmacol
. 2023 May;
141:105407.
PMID: 37141985
The non-clinical safety profile of the small molecule hepatitis B virus viral expression inhibitor RG7834 was studied in a package consisting of safety pharmacology, genotoxicity, repeat dose toxicity and reproductive...
5.
Vargas H, Rossman E, Wisialowski T, Nichols J, Pugsley M, Roche B, et al.
J Pharmacol Toxicol Methods
. 2023 Mar;
121:107265.
PMID: 36997076
Recent updates and modifications to the clinical ICH E14 and nonclinical ICH S7B guidelines, which both relate to the evaluation of drug-induced delayed repolarization risk, provide an opportunity for nonclinical...
6.
Boulay E, Miraucourt L, Pugsley M, Abernathy M, Chui R, Dalton J, et al.
J Pharmacol Toxicol Methods
. 2023 Mar;
121:107266.
PMID: 36963703
Introduction: Characterization of the incidence of spontaneous arrhythmias to identify possible drug-related effects is often an important part of the analysis in safety pharmacology studies using telemetry. Methods: A retrospective...
7.
Greiter-Wilke A, Roberts S, Heinig K, Waiz D, Jenni R, Holzgrefe H
J Pharmacol Toxicol Methods
. 2022 Mar;
115:107167.
PMID: 35301126
Pending updates to ICH S7B/E14 guidelines will enable the substitution of human TQT studies with support from concomitant negative hERG and non-rodent CV studies. This retrospective analysis compared the effects...
8.
Vargas H, Rolf M, Wisialowski T, Achanzar W, Bahinski A, Bass A, et al.
Clin Pharmacol Ther
. 2020 Sep;
109(2):310-318.
PMID: 32866317
Defining an appropriate and efficient assessment of drug-induced corrected QT interval (QTc) prolongation (a surrogate marker of torsades de pointes arrhythmia) remains a concern of drug developers and regulators worldwide....
9.
Li Z, Mirams G, Yoshinaga T, Ridder B, Han X, Chen J, et al.
Clin Pharmacol Ther
. 2019 Nov;
107(1):102-111.
PMID: 31709525
This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental...
10.
Guth B, Grobler A, Frazier K, Greiter-Wilke A, Herzyk D, Hough T, et al.
J Pharmacol Toxicol Methods
. 2019 May;
98:106579.
PMID: 31085319
This meeting report is based on presentations given at the first Drug Safety Africa Meeting in Potchefstroom, South Africa from November 20-22, 2018 at the North-West University campus. There were...