Lester R - Search Results

1

Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24-Hour Holter Electrocardiogram Recordings.

Skovgaard D, Haahr PM, Lester R, Clark K, Paglialunga S, Finer N, Friedrichsen MH, Hjerpsted JB, Engelmann MDM. Skovgaard D, et al. Among authors: lester r. J Clin Pharmacol. 2023 May;63(5):539-543. doi: 10.1002/jcph.2193. Epub 2023 Jan 20. J Clin Pharmacol. 2023. PMID: 36524539 Clinical Trial.

2

Evaluating cardiac risk: exposure response analysis in early clinical drug development.

Grenier J, Paglialunga S, Morimoto BH, Lester RM. Grenier J, et al. Drug Healthc Patient Saf. 2018 Apr 18;10:27-36. doi: 10.2147/DHPS.S133286. eCollection 2018. Drug Healthc Patient Saf. 2018. PMID: 29713203 Free PMC article. Review.

3

QT Assessment in Early Drug Development: The Long and the Short of It.

Lester RM, Paglialunga S, Johnson IA. Lester RM, et al. Int J Mol Sci. 2019 Mar 15;20(6):1324. doi: 10.3390/ijms20061324. Int J Mol Sci. 2019. PMID: 30884748 Free PMC article. Review.

4

Effect of Futibatinib on Cardiac Repolarization: Results of a Randomized, Controlled, Double-Blind, QT/QTc, Phase 1 Study in Healthy Subjects.

Yamamiya I, Lester R, Sonnichsen D, Mina M, He Y, Benhadji KA. Yamamiya I, et al. Among authors: lester r. Clin Pharmacol Drug Dev. 2023 Mar;12(3):304-313. doi: 10.1002/cpdd.1195. Epub 2022 Nov 20. Clin Pharmacol Drug Dev. 2023. PMID: 36404525 Clinical Trial.

5

Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability.

Lester RM, Engel C, van Haarst AD, Paglialunga S. Lester RM, et al. Clin Pharmacol Ther. 2024 Jul;116(1):42-51. doi: 10.1002/cpt.3284. Epub 2024 May 2. Clin Pharmacol Ther. 2024. PMID: 38698592 Review.

6

Early drug development: assessment of proarrhythmic risk and cardiovascular safety.

Lester RM, Olbertz J. Lester RM, et al. Expert Rev Clin Pharmacol. 2016 Dec;9(12):1611-1618. doi: 10.1080/17512433.2016.1245142. Epub 2016 Oct 27. Expert Rev Clin Pharmacol. 2016. PMID: 27718759 Review.

7

Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the "Double-Negative" Scenario.

Lester RM. Lester RM. Clin Pharmacol Drug Dev. 2021 Sep;10(9):964-973. doi: 10.1002/cpdd.1003. Epub 2021 Jul 31. Clin Pharmacol Drug Dev. 2021. PMID: 34331518 Free PMC article. Review.

8

A Randomized, Double-Blind, Parallel Design Thorough QT Study With a Nested Crossover to Compare the Cardiac Safety of Amiselimod With Placebo and Positive Control in Healthy Volunteers.

Lee J, Lester R, O'Reilly T, Lowe ER, Slatkin NE, Franklin H, Israel RJ. Lee J, et al. Among authors: lester r. Clin Pharmacol Drug Dev. 2023 Mar;12(3):236-248. doi: 10.1002/cpdd.1210. Epub 2023 Jan 28. Clin Pharmacol Drug Dev. 2023. PMID: 36708138 Clinical Trial.

9

P029 Pharmacokinetic/Pharmacodynamic Analysis of Amiselimod, a Selective Sphingosine 1-Phosphate Receptor Modulator, in Healthy Subjects: Results From a Phase 1 Study.

Lee J, Lester R, O'Reilly T, Lowe E, Slatkin N, Franklin H, Israel R. Lee J, et al. Among authors: lester r. Am J Gastroenterol. 2021 Dec 1;116(Suppl 1):S7. doi: 10.14309/01.ajg.0000798716.85306.ca. Am J Gastroenterol. 2021. PMID: 37461948

10

Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin: A Randomized, Dose Escalation Study in Healthy Adults.

Kavoosi M, O'Reilly TE, Kavoosi M, Chai P, Engel C, Korz W, Gallen CC, Lester RM. Kavoosi M, et al. Toxins (Basel). 2020 Aug 9;12(8):511. doi: 10.3390/toxins12080511. Toxins (Basel). 2020. PMID: 32784930 Free PMC article. Clinical Trial.

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