Publications by authors named "Michael Fossler"

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It Is Time to Re-Think the Limit of Quantitation.
Michael J Fossler, Brian Smith

Clin Pharmacol Drug Dev· December 2025

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What Does an Editor Do in 2025?
Amalia M Issa, Michael Fossler, Vijay V Upreti

Clin Pharmacol Drug Dev· November 2025

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Honoring the Extensive and Impactful Contributions of Prof David J Greenblatt, MD: Founding Editor of Clinical Pharmacology in Drug Development.
Vikram Arya, Michael Fossler, Oliver Grundmann

Clin Pharmacol Drug Dev· August 2025

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Commentary on Improving the Efficiency of Clinical Pharmacology Studies.
Michael J Fossler

Clin Pharmacol Drug Dev· August 2023

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The effect of TRV027 on coagulation in COVID-19: A pilot randomized, placebo-controlled trial.
Alexander J Robbins, Nur Amalina Che Bakri, Edward Toke-Bjolgerud, Aaron Edwards, Asha Vikraman, Michael Fossler

Br J Clin Pharmacol· April 2023

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Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine.
Pieter Simons, Rutger van der Schrier, Maarten van Lemmen, Simone Jansen, Kiki W K Kuijpers, Michael Fossler

Anesthesiology· March 2023

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The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials.
Kenneth T Moore, Michael J Fossler, Islam Younis,

J Clin Pharmacol· December 2022

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Budget impact and pharmacy costs with targeted use of oliceridine for postsurgical pain in patients at high risk of opioid-related adverse events.
Kit N Simpson, Michael J Fossler, Linda Wase, Mark A Demitrack, Todd L Wandstrat

Expert Rev Pharmacoecon Outcomes Res· June 2022

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Two-Part Phase 1 Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of TRV734 in Healthy Adults.
Kimberly A Ramos, Ian E James, Franck Skobieranda, David G Soergel, Dennis Ruff, Michael J Fossler

Clin Pharmacol Drug Dev· January 2022

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Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials.
Gregory B Hammer, Ashish K Khanna, Cathy Michalsky, Linda Wase, Mark A Demitrack, Michael J Fossler

Pain Ther· December 2021

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Intracellular uptake of agents that block the hERG channel can confound the assessment of QT interval prolongation and arrhythmic risk.
Alexander Burashnikov, Hector Barajas-Martinez, Robert Cox, Mark A Demitrack, Michael J Fossler

Heart Rhythm· December 2021

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Cost-effectiveness and cost-benefit analysis of oliceridine in the treatment of acute pain.
Kit N Simpson, Michael J Fossler, Linda Wase, Mark A Demitrack

J Comp Eff Res· October 2021

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Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials.
Timothy L Beard, Cathy Michalsky, Keith A Candiotti, Paul Rider, Linda Wase, Michael J Fossler

Pain Ther· June 2021

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Benefit and Risk Evaluation of Biased μ-Receptor Agonist Oliceridine versus Morphine.
Albert Dahan, C Jan van Dam, Marieke Niesters, Monique van Velzen, Michael J Fossler

Anesthesiology· September 2020

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Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.
Sabry Ayad, Mark A Demitrack, David A Burt, Cathy Michalsky, Linda Wase, Michael J Fossler

Clin Drug Investig· August 2020

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A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.
Michael J Fossler, Virginia Schmith, Stephen A Greene, Lauren Lohmer, Michael S Kramer

CNS Drugs· August 2020

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The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine.
Anne N Nafziger, Kelly A Arscott, Kristina Cochrane, Franck Skobieranda, David A Burt, Michael J Fossler

Clin Pharmacol Drug Dev· July 2020

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A First-in-Human Clinical Study With TRV734, an Orally Bioavailable G-Protein-Biased Ligand at the μ-Opioid Receptor.
Ian E James, Franck Skobieranda, David G Soergel, Kimberly A Ramos, Dennis Ruff, Michael J Fossler

Clin Pharmacol Drug Dev· February 2020

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Functionally Selective Inhibition of the Oxytocin Receptor by Retosiban in Human Myometrial Smooth Muscle.
Paul J Brighton, Michael J Fossler, Siobhan Quenby, Andrew M Blanks

Endocrinology· February 2020

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A Randomized, Placebo-Controlled Trial to Assess the Effects of 8 Weeks of Administration of GSK256073, a Selective GPR109A Agonist, on High-Density Lipoprotein Cholesterol in Subjects With Dyslipidemia.
Eric J Olson, Kelly M Mahar, Thomas F Haws, Michael J Fossler, Feng Gao

Clin Pharmacol Drug Dev· October 2019

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Population Pharmacokinetics of Pemetrexed in Adult Non-Small Cell Lung Cancer in Indian Patients.
Meenakshi Srinivasan, Ayyappa Chaturvedula, Michael J Fossler, Anand Patil, Vikram Gota

J Clin Pharmacol· September 2019

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Tenofovir Plasma Concentration from Preexposure Prophylaxis at the Time of Potential HIV Exposure: a Population Pharmacokinetic Modeling and Simulation Study Involving Serodiscordant Couples in East Africa.
Surulivelrajan Mallayasamy, Ayyappa Chaturvedula, Michael J Fossler, Mark Sale, Vineet Goti

Antimicrob Agents Chemother· August 2019

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The Potential Role of the J-T Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium.
Jose Vicente, David G Strauss, Vijay V Upreti, Michael J Fossler, Philip T Sager

J Clin Pharmacol· July 2019

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Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach.
Surulivelrajan Mallayasamy, Ayyappa Chaturvedula, Michael J Fossler, Mark E Sale, Craig W Hendrix

Front Pharmacol· July 2019

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A Systematic Evaluation of Effect of Adherence Patterns on the Sample Size and Power of a Clinical Study.
Surulivelrajan Mallayasamy, Ayyappa Chaturvedula, Terrence Blaschke, Michael J Fossler

CPT Pharmacometrics Syst Pharmacol· December 2018

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