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Items: 50

1.

Functionally selective inhibition of the oxytocin receptor by retosiban in human myometrial smooth muscle.

Brighton PJ, Fossler MJ, Quenby S, Blanks AM.

Endocrinology. 2020 Jan 7. pii: bqz043. doi: 10.1210/endocr/bqz043. [Epub ahead of print]

PMID:
31907536
2.

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

Nafziger AN, Arscott KA, Cochrane K, Skobieranda F, Burt DA, Fossler MJ.

Clin Pharmacol Drug Dev. 2019 Nov 7. doi: 10.1002/cpdd.750. [Epub ahead of print]

PMID:
31697049
3.

Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach.

Mallayasamy S, Chaturvedula A, Fossler MJ, Sale ME, Hendrix CW, Haberer JE.

Front Pharmacol. 2019 Jul 12;10:785. doi: 10.3389/fphar.2019.00785. eCollection 2019.

4.

A First-in-Human Clinical Study With TRV734, an Orally Bioavailable G-Protein-Biased Ligand at the μ-Opioid Receptor.

James IE, Skobieranda F, Soergel DG, Ramos KA, Ruff D, Fossler MJ.

Clin Pharmacol Drug Dev. 2020 Feb;9(2):256-266. doi: 10.1002/cpdd.721. Epub 2019 Jul 8.

PMID:
31286645
5.

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.

Olson EJ, Mahar KM, Haws TF, Fossler MJ, Gao F, de Gouville AC, Sprecher DL, Lepore JJ.

Clin Pharmacol Drug Dev. 2019 Oct;8(7):871-883. doi: 10.1002/cpdd.704. Epub 2019 Jul 3.

PMID:
31268250
6.

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.

Mallayasamy S, Chaturvedula A, Fossler MJ, Sale M, Goti V, Bumpus NN, Marzinke MA, Hendrix CW, Haberer JE; Partners Demonstration Project Team.

Antimicrob Agents Chemother. 2019 Jul 25;63(8). pii: e00446-19. doi: 10.1128/AAC.00446-19. Print 2019 Aug.

7.

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

Srinivasan M, Chaturvedula A, Fossler MJ, Patil A, Gota V, Prabhash K.

J Clin Pharmacol. 2019 Sep;59(9):1216-1224. doi: 10.1002/jcph.1417. Epub 2019 Apr 11.

PMID:
30973978
8.

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.

Vicente J, Strauss DG, Upreti VV, Fossler MJ, Sager PT, Noveck R.

J Clin Pharmacol. 2019 Jul;59(7):909-914. doi: 10.1002/jcph.1411. Epub 2019 Mar 25. No abstract available.

PMID:
30907981
9.

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

Mallayasamy S, Chaturvedula A, Blaschke T, Fossler MJ.

CPT Pharmacometrics Syst Pharmacol. 2018 Dec;7(12):818-828. doi: 10.1002/psp4.12361. Epub 2018 Oct 28.

10.

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

Goti V, Chaturvedula A, Fossler MJ, Mok S, Jacob JT.

Ther Drug Monit. 2018 Apr;40(2):212-221. doi: 10.1097/FTD.0000000000000490. Erratum in: Ther Drug Monit. 2019 Aug;41(4):549.

PMID:
29470227
11.

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 MJ, Sadler BM, Farrell C, Burt DA, Pitsiu M, Skobieranda F, Soergel DG.

J Clin Pharmacol. 2018 Jun;58(6):750-761. doi: 10.1002/jcph.1076. Epub 2018 Feb 7.

PMID:
29412458
12.
13.

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 N, Minkowitz HS, Soergel DG, Burt DA, Subach RA, Salamea MY, Fossler MJ, Skobieranda F.

J Pain Res. 2017 Oct 6;10:2413-2424. doi: 10.2147/JPR.S137952. eCollection 2017.

14.

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

Barbour AM, Fossler MJ.

J Clin Pharmacol. 2018 Jan;58(1):25-28. doi: 10.1002/jcph.991. Epub 2017 Aug 16. No abstract available.

PMID:
28815729
15.

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

Thornton S, Valenzuela G, Baidoo C, Fossler MJ, Montague TH, Clayton L, Powell M, Snidow J, Stier B, Soergel D.

Br J Clin Pharmacol. 2017 Oct;83(10):2283-2291. doi: 10.1111/bcp.13336. Epub 2017 Jul 11.

16.

Some Thoughts About the Mean Concentration-Versus-Time Plot.

Fossler MJ.

Clin Pharmacol Drug Dev. 2017 May;6(3):220-223. doi: 10.1002/cpdd.353. No abstract available.

PMID:
28475821
17.

Markov Mixed Effects Modeling Using Electronic Adherence Monitoring Records Identifies Influential Covariates to HIV Preexposure Prophylaxis.

Madrasi K, Chaturvedula A, Haberer JE, Sale M, Fossler MJ, Bangsberg D, Baeten JM, Celum C, Hendrix CW.

J Clin Pharmacol. 2017 May;57(5):606-615. doi: 10.1002/jcph.843. Epub 2016 Dec 6.

PMID:
27922719
18.

Population Pharmacokinetics of Tenofovir in HIV-1-Uninfected Members of Serodiscordant Couples and Effect of Dose Reporting Methods.

Lu Y, Goti V, Chaturvedula A, Haberer JE, Fossler MJ, Sale ME, Bangsberg D, Baeten JM, Celum CL, Hendrix CW.

Antimicrob Agents Chemother. 2016 Aug 22;60(9):5379-86. doi: 10.1128/AAC.00559-16. Print 2016 Sep.

19.

Edible Cannabis Products: It Is Time for FDA Oversight.

Benjamin DM, Fossler MJ.

J Clin Pharmacol. 2016 Sep;56(9):1045-7. doi: 10.1002/jcph.778. Epub 2016 Jul 12. No abstract available.

PMID:
27270959
20.

Effect of tamsulosin on the pharmacokinetics of dutasteride in Chinese male healthy volunteers.

Li H, Yang J, Zhao H, Fossler MJ, Wang C.

Clin Pharmacol Drug Dev. 2015 Nov;4(6):427-33. doi: 10.1002/cpdd.197. Epub 2015 Jul 20.

PMID:
27137714
21.

Pharmacometrics: Focus on the Patient.

Dumitrescu TP, Fossler MJ, Schmith VD.

CPT Pharmacometrics Syst Pharmacol. 2015 Jan;4(1):e00005. doi: 10.1002/psp4.5. Epub 2014 Dec 30.

22.

Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study.

Thornton S, Miller H, Valenzuela G, Snidow J, Stier B, Fossler MJ, Montague TH, Powell M, Beach KJ.

Br J Clin Pharmacol. 2015 Oct;80(4):740-9. doi: 10.1111/bcp.12646. Epub 2015 Jun 1. Erratum in: Br J Clin Pharmacol. 2015 Sep;80(3):609.

23.

Utility of concentration-effect modeling and simulation in a thorough QT study of losmapimod.

Barbour AM, Magee M, Shaddinger B, Arya N, Tombs L, Tao W, Patel BR, Fossler MJ, Glaser R.

J Clin Pharmacol. 2015 Jun;55(6):661-70. doi: 10.1002/jcph.465. Epub 2015 Feb 13.

PMID:
25612153
24.

Evaluation of bioequivalence of five 0.1 mg dutasteride capsules compared to one 0.5 mg dutasteride capsule: a randomized study in healthy male volunteers.

Fossler MJ, Collins DA, Ino H, Sarai N, Ravindranath R, Bowen CL, Burns O.

J Drug Assess. 2015 Jul 14;4(1):24-9. doi: 10.3109/21556660.2015.1067219. eCollection 2015.

25.

Linking the population pharmacokinetics of tenofovir and its metabolites with its cellular uptake and metabolism.

Madrasi K, Burns RN, Hendrix CW, Fossler MJ, Chaturvedula A.

CPT Pharmacometrics Syst Pharmacol. 2014 Nov 12;3:e147. doi: 10.1038/psp.2014.46.

26.

Patient adherence: clinical pharmacology's embarrassing relative.

Fossler MJ.

J Clin Pharmacol. 2015 Apr;55(4):365-7. doi: 10.1002/jcph.426. Epub 2015 Jan 16. No abstract available.

PMID:
25385704
27.

Practical considerations for dose selection in pediatric patients to ensure target exposure requirements.

Barbour AM, Fossler MJ, Barrett J.

AAPS J. 2014 Jul;16(4):749-55. doi: 10.1208/s12248-014-9603-x. Epub 2014 May 20. Review.

28.

Pharmacokinetic bioequivalence studies of a fixed-dose combination of tamsulosin and dutasteride in healthy volunteers.

Fossler MJ, Collins DA, Thompson MM, Nino A, Bianco JJ, Chetty D.

Clin Drug Investig. 2014 May;34(5):335-49. doi: 10.1007/s40261-014-0179-0.

PMID:
24615171
29.

Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.

Chaturvedula A, Fossler MJ, Hendrix CW.

J Clin Pharmacol. 2014 Feb;54(2):150-60. doi: 10.1002/jcph.221. Epub 2013 Nov 30.

30.

A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms.

Zajicek A, Fossler MJ, Barrett JS, Worthington JH, Ternik R, Charkoftaki G, Lum S, Breitkreutz J, Baltezor M, Macheras P, Khan M, Agharkar S, MacLaren DD.

AAPS J. 2013 Oct;15(4):1072-81. doi: 10.1208/s12248-013-9511-5. Epub 2013 Aug 2. Review.

31.

Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers.

Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J.

Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.

32.

Population pharmacokinetics and pharmacodynamics of ribavirin in patients with chronic hepatitis C genotype 1 infection.

Jin R, Fossler MJ, McHutchison JG, Howell CD, Dowling TC.

AAPS J. 2012 Sep;14(3):571-80. doi: 10.1208/s12248-012-9368-z. Epub 2012 May 26.

33.

Relative Bioavailability of an Emulsion Formulation for Omega-3-Acid Ethyl Esters Compared to the Commercially Available Formulation: A Randomized, Parallel-Group, Single-Dose Study Followed by Repeat Dosing in Healthy Volunteers.

Hussey EK, Portelli S, Fossler MJ, Gao F, Harris WS, Blum RA, Lates CD, Gould E, Abu-Baker O, Johnson S, Reddy KK.

Clin Pharmacol Drug Dev. 2012 Jan;1(1):14-23. doi: 10.1177/2160763X11431107.

PMID:
27206142
34.

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.

Cai G, Thiessen JJ, Baidoo CA, Fossler MJ.

J Clin Pharmacol. 2010 Oct;50(10):1142-50. doi: 10.1177/0091270009355155. Epub 2010 Feb 16.

PMID:
20160156
35.

Globalization of quantitative pharmacology: first international symposium of quantitative pharmacology in drug development and regulation.

Barrett JS, Shi J, Xie HT, Huang XH, Fossler MJ, Sun RY.

J Clin Pharmacol. 2008 Jul;48(7):787-92. doi: 10.1177/0091270008319331. Epub 2008 May 19.

PMID:
18490494
36.

Pharmacometrics: a multidisciplinary field to facilitate critical thinking in drug development and translational research settings.

Barrett JS, Fossler MJ, Cadieu KD, Gastonguay MR.

J Clin Pharmacol. 2008 May;48(5):632-49. doi: 10.1177/0091270008315318. Review.

PMID:
18440922
37.

Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults.

Menon-Andersen D, Mondick JT, Jayaraman B, Thompson PA, Blaney SM, Bernstein M, Bond M, Champagne M, Fossler MJ, Barrett JS.

Cancer Chemother Pharmacol. 2009 Jan;63(2):229-38. doi: 10.1007/s00280-008-0730-x. Epub 2008 Apr 9.

PMID:
18398615
38.

Pharmacokinetics and pharmacodynamics of DPC 333 ((2R)-2-((3R)-3-amino-3{4-[2-methyl-4-quinolinyl) methoxy] phenyl}-2-oxopyrrolidinyl)-N-hydroxy-4-methylpentanamide)), a potent and selective inhibitor of tumor necrosis factor alpha-converting enzyme in rodents, dogs, chimpanzees, and humans.

Qian M, Bai SA, Brogdon B, Wu JT, Liu RQ, Covington MB, Vaddi K, Newton RC, Fossler MJ, Garner CE, Deng Y, Maduskuie T, Trzaskos J, Duan JJ, Decicco CP, Christ DD.

Drug Metab Dispos. 2007 Oct;35(10):1916-25. Epub 2007 Jul 26.

PMID:
17656469
40.
41.

Integrated pharmacokinetic/pharmacodynamic model of XV459, a potent and specific GPIIb/IIIa inhibitor, in healthy male volunteers.

Fossler MJ, Ebling WF, Ma S, Kornhauser D, Mondick J, Barrett JS, Garner D, Quon CY, Pieniaszek HJ Jr.

J Clin Pharmacol. 2002 Dec;42(12):1326-34.

PMID:
12463727
42.

Intravenous and subcutaneous weight-based dosing of the low molecular weight heparin tinzaparin (Innohep) in end-stage renal disease patients undergoing chronic hemodialysis.

Hainer JW, Sherrard DJ, Swan SK, Barrett JS, Assaid CA, Fossler MJ, Cox DS, Williams RM, Pittenger AL, Stephenson CA, Hua TA.

Am J Kidney Dis. 2002 Sep;40(3):531-8.

PMID:
12200805
43.
44.

Dosing in heavy-weight/obese patients with the LMWH, tinzaparin: a pharmacodynamic study.

Hainer JW, Barrett JS, Assaid CA, Fossler MJ, Cox DS, Leathers T, Leese PT.

Thromb Haemost. 2002 May;87(5):817-23.

PMID:
12038783
45.

Modeling the pharmacokinetics and pharmacodynamics of a unique oral hypoglycemic agent using neural networks.

Haidar SH, Johnson SB, Fossler MJ, Hussain AS.

Pharm Res. 2002 Jan;19(1):87-91.

PMID:
11837705
46.

Pharmacodynamics of intravenous and subcutaneous tinzaparin and heparin in healthy volunteers.

Fossler MJ, Barrett JS, Hainer JW, Riddle JG, Ostergaard P, van der Elst E, Sprogel P.

Am J Health Syst Pharm. 2001 Sep 1;58(17):1614-21.

PMID:
11556655
47.

Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets.

Eddington ND, Ashraf M, Augsburger LL, Leslie JL, Fossler MJ, Lesko LJ, Shah VP, Rekhi GS.

Pharm Dev Technol. 1998 Nov;3(4):535-47.

PMID:
9834957
48.

Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations.

Rekhi GS, Eddington ND, Fossler MJ, Schwartz P, Lesko LJ, Augsburger LL.

Pharm Dev Technol. 1997 Feb;2(1):11-24.

PMID:
9552427
49.

A reversed-phase ion-pair liquid chromatography method for the determination of 4-aminopyridine in Sprague-Dawley rats.

Fossler MJ, Leslie J, Burke M, Devane J, Young D.

J Pharm Biomed Anal. 1994 Feb;12(2):281-5. No abstract available.

PMID:
8003556
50.

Effect of quinidine on the interconversion kinetics between haloperidol and reduced haloperidol in humans: implications for the involvement of cytochrome P450IID6.

Young D, Midha KK, Fossler MJ, Hawes EM, Hubbard JW, McKay G, Korchinski ED.

Eur J Clin Pharmacol. 1993;44(5):433-8.

PMID:
8359179

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