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Commentary on Improving the Efficiency of Clinical Pharmacology Studies

Clinical pharmacology in drug development, 2023-08, Vol.12 (8), p.775-778

Fossler, Michael J.

2023

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A randomized, Phase IIb study investigating oliceridine (TRV130), a novel µ-receptor G-protein pathway selective (μ-GPS) modulator, for the management of moderate to severe acute pain following abdominoplasty

Journal of pain research, 2017-01, Vol.10, p.2413-2424

2017

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The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials

Journal of clinical pharmacology, 2022-12, Vol.62 (12), p.1465-1467

2022

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Benefit and Risk Evaluation of Biased μ-Receptor Agonist Oliceridine versus Morphine

Anesthesiology (Philadelphia), 2020-09, Vol.133 (3), p.559-568

2020

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Patient adherence: Clinical pharmacology's embarrassing relative

Journal of clinical pharmacology, 2015-04, Vol.55 (4), p.365-367

Fossler, Michael J.

2015

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Functionally Selective Inhibition of the Oxytocin Receptor by Retosiban in Human Myometrial Smooth Muscle

Endocrinology (Philadelphia), 2020-02, Vol.161 (2), p.1

2020

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Edible Cannabis Products: It Is Time for FDA Oversight

Journal of clinical pharmacology, 2016-09, Vol.56 (9), p.1045-1047

2016

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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

CNS drugs, 2020-08, Vol.34 (8), p.853-865

2020

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Hospitalized Patients With and Without Hemodialysis Have Markedly Different Vancomycin Pharmacokinetics: A Population Pharmacokinetic Model-Based Analysis

Therapeutic drug monitoring, 2018-04, Vol.40 (2), p.212-221

2018

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Oliceridine (TRV130), a Novel G Protein–Biased Ligand at the μ‐Opioid Receptor, Demonstrates a Predictable Relationship Between Plasma Concentrations and Pain Relief. I: Development of a Pharmacokinetic/Pharmacodynamic Model

Journal of clinical pharmacology, 2018-06, Vol.58 (6), p.750-761

2018

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The Potential Role of the J‐Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium

Journal of clinical pharmacology, 2019-07, Vol.59 (7), p.909-914

2019

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The Potential Role of the J-T peak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium

Journal of clinical pharmacology, 2019-07, Vol.59 (7), p.909-914

2019

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Population Pharmacokinetics of Pemetrexed in Adult Non–Small Cell Lung Cancer in Indian Patients

Journal of clinical pharmacology, 2019-09, Vol.59 (9), p.1216-1224

2019

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Intracellular uptake of agents that block the hERG channel can confound the assessment of QT interval prolongation and arrhythmic risk

Heart rhythm, 2021-12, Vol.18 (12), p.2177-2186

2021

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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

Clinical drug investigation, 2020-08, Vol.40 (8), p.755-764

2020

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A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

The AAPS journal, 2013-10, Vol.15 (4), p.1072-1081

2013

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Infusions Are the Optimal Dosing Method in Intravenous ADME Studies Rather Than Bolus Dosing

Journal of clinical pharmacology, 2018-01, Vol.58 (1), p.25-28

2018

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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

Expert review of pharmacoeconomics & outcomes research, 2022-05, Vol.22 (4), p.671-681

2022

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Effects of the Novel Long-Acting GLP-1 Agonist, Albiglutide, on Cardiac Function, Cardiac Metabolism, and Exercise Capacity in Patients With Chronic Heart Failure and Reduced Ejection Fraction

JACC. Heart failure, 2016-07, Vol.4 (7), p.559-566

2016

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A Systematic Evaluation of Effect of Adherence Patterns on the Sample Size and Power of a Clinical Study

CPT: pharmacometrics and systems pharmacology, 2018-12, Vol.7 (12), p.818-828

2018

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Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose‐ranging study

British journal of clinical pharmacology, 2017-10, Vol.83 (10), p.2283-2291

2017

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The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine

Clinical pharmacology in drug development, 2020-07, Vol.9 (5), p.639-650

2020

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Cost–effectiveness and cost-benefit analysis of oliceridine in the treatment of acute pain

Journal of comparative effectiveness research, 2021-10, Vol.10 (15), p.1107-1119

2021

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Some Thoughts About the Mean Concentration‐Versus‐Time Plot

Clinical pharmacology in drug development, 2017-05, Vol.6 (3), p.220-223

Fossler, Michael J.

2017

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Maternofetal pharmacokinetics and fetal lung responses in chronically catheterized sheep receiving constant, low-dose infusions of betamethasone phosphate

American journal of obstetrics and gynecology, 2016-12, Vol.215 (6), p.775.e1-775.e12

2016

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Commentary on Improving the Efficiency of Clinical Pharmacology Studies

A randomized, Phase IIb study investigating oliceridine (TRV130), a novel µ-receptor G-protein pathway selective (μ-GPS) modulator, for the management of moderate to severe acute pain following abdominoplasty

The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials

Benefit and Risk Evaluation of Biased μ-Receptor Agonist Oliceridine versus Morphine

Patient adherence: Clinical pharmacology's embarrassing relative

Functionally Selective Inhibition of the Oxytocin Receptor by Retosiban in Human Myometrial Smooth Muscle

Edible Cannabis Products: It Is Time for FDA Oversight

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

Hospitalized Patients With and Without Hemodialysis Have Markedly Different Vancomycin Pharmacokinetics: A Population Pharmacokinetic Model-Based Analysis

Oliceridine (TRV130), a Novel G Protein–Biased Ligand at the μ‐Opioid Receptor, Demonstrates a Predictable Relationship Between Plasma Concentrations and Pain Relief. I: Development of a Pharmacokinetic/Pharmacodynamic Model

The Potential Role of the J‐Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium

The Potential Role of the J-T peak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium

Population Pharmacokinetics of Pemetrexed in Adult Non–Small Cell Lung Cancer in Indian Patients

Intracellular uptake of agents that block the hERG channel can confound the assessment of QT interval prolongation and arrhythmic risk

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

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

Infusions Are the Optimal Dosing Method in Intravenous ADME Studies Rather Than Bolus Dosing

Budget impact and pharmacy costs with targeted use of oliceridine for postsurgical pain in patients at high risk of opioid-related adverse events

Effects of the Novel Long-Acting GLP-1 Agonist, Albiglutide, on Cardiac Function, Cardiac Metabolism, and Exercise Capacity in Patients With Chronic Heart Failure and Reduced Ejection Fraction

A Systematic Evaluation of Effect of Adherence Patterns on the Sample Size and Power of a Clinical Study

Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose‐ranging study

The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine

Cost–effectiveness and cost-benefit analysis of oliceridine in the treatment of acute pain

Some Thoughts About the Mean Concentration‐Versus‐Time Plot

Maternofetal pharmacokinetics and fetal lung responses in chronically catheterized sheep receiving constant, low-dose infusions of betamethasone phosphate

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