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
Singla, Neil, Minkowitz, Harold S, Soergel, David G, Burt, David A, Subach, Ruth Ann, Salamea, Monica Y, Fossler, Michael J, Skobieranda, Franck
Published in Journal of pain research (01.01.2017)
Published in Journal of pain research (01.01.2017)
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A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms
Zajicek, Anne, Fossler, Michael J., Barrett, Jeffrey S., Worthington, Jeffrey H., Ternik, Robert, Charkoftaki, Georgia, Lum, Susan, Breitkreutz, Jörg, Baltezor, Mike, Macheras, Panos, Khan, Mansoor, Agharkar, Shreeram, MacLaren, David Douglas
Published in The AAPS journal (01.10.2013)
Published in The AAPS journal (01.10.2013)
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Pharmacometrics: a multidisciplinary field to facilitate critical thinking in drug development and translational research settings
Barrett, Jeffrey S, Fossler, Michael J, Cadieu, K David, Gastonguay, Marc R
Published in Journal of clinical pharmacology (01.05.2008)
Published in Journal of clinical pharmacology (01.05.2008)
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Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach
Mallayasamy, Surulivelrajan, Chaturvedula, Ayyappa, Fossler, Michael J, Sale, Mark E, Hendrix, Craig W, Haberer, Jessica E
Published in Frontiers in pharmacology (12.07.2019)
Published in Frontiers in pharmacology (12.07.2019)
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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
Fossler, Michael J, Sadler, Brian M, Farrell, Colm, Burt, David A, Pitsiu, Maria, Skobieranda, Franck, Soergel, David G
Published in Journal of clinical pharmacology (01.06.2018)
Published in Journal of clinical pharmacology (01.06.2018)
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Dosing in heavy-weight/obese patients with the LMWH, tinzaparin: a pharmacodynamic study
Hainer, James W, Barrett, Jeffrey S, Assaid, Christopher A, Fossler, Michael J, Cox, Donna S, Leathers, Todd, Leese, Philip T
Published in Thrombosis and haemostasis (01.05.2002)
Published in Thrombosis and haemostasis (01.05.2002)
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Hospitalized Patients With and Without Hemodialysis Have Markedly Different Vancomycin Pharmacokinetics: A Population Pharmacokinetic Model-Based Analysis
Goti, Vineet, Chaturvedula, Ayyappa, Fossler, Michael J, Mok, Steve, Jacob, Jesse T
Published in Therapeutic drug monitoring (01.04.2018)
Published in Therapeutic drug monitoring (01.04.2018)
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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
Fossler, Michael J., Schmith, Virginia, Greene, Stephen A., Lohmer, Lauren, Kramer, Michael S., Arscott, Kelly, James, Ian E., Demitrack, Mark A.
Published in CNS drugs (01.08.2020)
Published in CNS drugs (01.08.2020)
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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
Fossler, Michael J, Sadler, Brian M, Farrell, Colm, Burt, David A, Pitsiu, Maria, Skobieranda, Franck, Soergel, David G
Published in Journal of clinical pharmacology (01.06.2018)
Published in Journal of clinical pharmacology (01.06.2018)
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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
Vicente, Jose, Strauss, David G, Upreti, Vijay V, Fossler, Michael J, Sager, Philip T, Noveck, Robert
Published in Journal of clinical pharmacology (01.07.2019)
Published in Journal of clinical pharmacology (01.07.2019)
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Population Pharmacokinetics of Pemetrexed in Adult Non-Small Cell Lung Cancer in Indian Patients
Srinivasan, Meenakshi, Chaturvedula, Ayyappa, Fossler, Michael J, Patil, Anand, Gota, Vikram, Prabhash, Kumar
Published in Journal of clinical pharmacology (01.09.2019)
Published in Journal of clinical pharmacology (01.09.2019)
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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
Ayad, Sabry, Demitrack, Mark A., Burt, David A., Michalsky, Cathy, Wase, Linda, Fossler, Michael J., Khanna, Ashish K.
Published in Clinical drug investigation (01.08.2020)
Published in Clinical drug investigation (01.08.2020)
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Intracellular uptake of agents that block the hERG channel can confound the assessment of QT interval prolongation and arrhythmic risk
Burashnikov, Alexander, Barajas-Martinez, Hector, Cox, Robert, Demitrack, Mark A., Fossler, Michael J., Kramer, Michael, Kleiman, Robert B., Kowey, Peter, Antzelevitch, Charles
Published in Heart rhythm (01.12.2021)
Published in Heart rhythm (01.12.2021)
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