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Commentary on Improving the Efficiency of Clinical Pharmacology Studies.
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- Clinical Pharmacology in Drug Development, 2023, v. 12, n. 8, p. 775, doi. 10.1002/cpdd.1295
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The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials.
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- Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1465, doi. 10.1002/jcph.2135
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- Article
Two‐Part Phase 1 Multiple‐Ascending‐Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of TRV734 in Healthy Adults.
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- Clinical Pharmacology in Drug Development, 2022, v. 11, n. 1, p. 51, doi. 10.1002/cpdd.1016
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- Article
Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials.
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- Pain & Therapy, 2021, v. 10, n. 2, p. 1343, doi. 10.1007/s40122-021-00299-0
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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.
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- Pain & Therapy, 2021, v. 10, n. 1, p. 401, doi. 10.1007/s40122-020-00216-x
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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.
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- Clinical Drug Investigation, 2020, v. 40, n. 8, p. 755, doi. 10.1007/s40261-020-00936-0
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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.
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- CNS Drugs, 2020, v. 34, n. 8, p. 853, doi. 10.1007/s40263-020-00738-0
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The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine.
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- Clinical Pharmacology in Drug Development, 2020, v. 9, n. 5, p. 639, doi. 10.1002/cpdd.750
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A First‐in‐Human Clinical Study With TRV734, an Orally Bioavailable G‐Protein–Biased Ligand at the μ‐Opioid Receptor.
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- Clinical Pharmacology in Drug Development, 2020, v. 9, n. 2, p. 256, doi. 10.1002/cpdd.721
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- Article
Functionally Selective Inhibition of the Oxytocin Receptor by Retosiban in Human Myometrial Smooth Muscle.
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- Endocrinology, 2020, v. 161, n. 2, p. 1, doi. 10.1210/endocr/bqz043
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- Article
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.
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- Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 871, doi. 10.1002/cpdd.704
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- Article
Population Pharmacokinetics of Pemetrexed in Adult Non–Small Cell Lung Cancer in Indian Patients.
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- Journal of Clinical Pharmacology, 2019, v. 59, n. 9, p. 1216, doi. 10.1002/jcph.1417
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Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach.
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- Frontiers in Pharmacology, 2019, p. 1, doi. 10.3389/fphar.2019.00785
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The Potential Role of the J‐T<sub>peak</sub> Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium.
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- Journal of Clinical Pharmacology, 2019, v. 59, n. 7, p. 909, doi. 10.1002/jcph.1411
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A Systematic Evaluation of Effect of Adherence Patterns on the Sample Size and Power of a Clinical Study.
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- CPT: Pharmacometrics & Systems Pharmacology, 2018, v. 7, n. 12, p. 818, doi. 10.1002/psp4.12361
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- Article
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.
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- Journal of Clinical Pharmacology, 2018, v. 58, n. 6, p. 750, doi. 10.1002/jcph.1076
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Oliceridine, a Novel G Protein-Biased Ligand at the μ-Opioid Receptor,Demonstrates a Predictable Relationship Between Plasma Concentrations and Pain Relief. II: Simulation of Potential Phase 3 Study Designs Using a Pharmacokinetic/Pharmacodynamic Model Michael
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- Journal of Clinical Pharmacology, 2018, v. 58, n. 6, p. 762, doi. 10.1002/jcph.1075
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Infusions Are the Optimal Dosing Method in Intravenous ADME Studies Rather Than Bolus Dosing.
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- Journal of Clinical Pharmacology, 2018, v. 58, n. 1, p. 25, doi. 10.1002/jcph.991
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Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose-ranging study.
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- British Journal of Clinical Pharmacology, 2017, v. 83, n. 10, p. 2283, doi. 10.1111/bcp.13336
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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.
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- Journal of Pain Research, 2017, v. 10, p. 2413, doi. 10.2147/jpr.s137952
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Some Thoughts About the Mean Concentration-Versus-Time Plot.
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- Clinical Pharmacology in Drug Development, 2017, v. 6, n. 3, p. 220, doi. 10.1002/cpdd.353
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Markov Mixed Effects Modeling Using Electronic Adherence Monitoring Records Identifies Influential Covariates to HIV Preexposure Prophylaxis.
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- Journal of Clinical Pharmacology, 2017, v. 57, n. 5, p. 606, doi. 10.1002/jcph.843
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Edible Cannabis Products: It Is Time for FDA Oversight.
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- Journal of Clinical Pharmacology, 2016, v. 56, n. 9, p. 1045, doi. 10.1002/jcph.778
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Effect of tamsulosin on the pharmacokinetics of dutasteride in Chinese male healthy volunteers.
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- Clinical Pharmacology in Drug Development, 2015, v. 4, n. 6, p. 427, doi. 10.1002/cpdd.197
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- Article
Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study.
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- British Journal of Clinical Pharmacology, 2015, v. 80, n. 4, p. 740, doi. 10.1111/bcp.12646
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Utility of concentration-effect modeling and simulation in a thorough QT study of losmapimod.
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- Journal of Clinical Pharmacology, 2015, v. 55, n. 6, p. 661, doi. 10.1002/jcph.465
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Patient adherence: Clinical pharmacology's embarrassing relative.
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- Journal of Clinical Pharmacology, 2015, v. 55, n. 4, p. 365, doi. 10.1002/jcph.426
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Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.
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- Journal of Clinical Pharmacology, 2014, v. 54, n. 2, p. 150, doi. 10.1002/jcph.221
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Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers.
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- British Journal of Clinical Pharmacology, 2013, v. 76, n. 1, p. 99, doi. 10.1111/bcp.12063
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Operating Characteristics of a Partial-Block Randomized Crossover Bioequivalence Study for Dutasteride, a Drug With a Long Half-Life: Investigation Through Simulation and Comparison With Final Results.
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- Journal of Clinical Pharmacology, 2010, v. 50, n. 10, p. 1142, doi. 10.1177/0091270009355155
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Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults.
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- Cancer Chemotherapy & Pharmacology, 2009, v. 63, n. 2, p. 229, doi. 10.1007/s00280-008-0730-x
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Globalization of Quantitative Pharmacology: First International Symposium of Quantitative Pharmacology in Drug Development and Regulation.
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- Journal of Clinical Pharmacology, 2008, v. 48, n. 7, p. 787, doi. 10.1177/0091270008319331
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Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research Settings.
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- Journal of Clinical Pharmacology, 2008, v. 48, n. 5, p. 632, doi. 10.1177/0091270008315318
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Pharmacokinetics and Pharmacodynamics of Argatroban in Combination with a Platelet Glycoprotein IIB/IIIA Receptor Antagonist in Patients Undergoing Percutaneous Coronary Intervention.
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- Journal of Clinical Pharmacology, 2004, v. 44, n. 9, p. 981
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Integrated Pharmacokinetic/Pharmacodynamic Model of XV459, a Potent and Specific GpIIb/IIIa Inhibitor, in Healthy Male Volunteers.
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- Journal of Clinical Pharmacology, 2002, v. 42, n. 12, p. 1326, doi. 10.1177/0091270002042012003
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Safety, Tolerability, Pharmacokinetics, and Time Course of Pharmacologic Response of the Active Metabolite of Roxifiban, XV459, a Glycoprotein IIb/IIIa Antagonist, following Oral Administration in Healthy Volunteers.
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- Journal of Clinical Pharmacology, 2002, v. 42, n. 7, p. 738, doi. 10.1177/009127000204200705
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