Fossler, Michael J.: search on Z-Library

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1

Pharmacokinetic Bioequivalence Studies of a Fixed-Dose Combination of Tamsulosin and Dutasteride in Healthy Volunteers

Fossler, Michael J., Collins, David A., Thompson, Meg M., Nino, Antonio, Bianco, Joseph J., Chetty, Dushen

Journal:

Clinical Drug Investigation

Year:

2014

Language:

english

File:

PDF, 535 KB

english, 2014

2

Evaluation of in Vitro Release Rate and in Vivo Absorption Characteristics of Four Metoprolol Tartrate Immediate-Release Tablet Formulations

Rekhi, Gurvinder Singh, Eddington, Natalie D., Fossler, Michael J., Schwartz, Paul, Lesko, Lawrence J., Augsburger, Larry L.

Journal:

Pharmaceutical Development and Technology

Year:

1997

Language:

english

File:

PDF, 1.01 MB

english, 1997

3

Modeling the Pharmacokinetics and Pharmacodynamics of a Unique Oral Hypoglycemic Agent Using Neural Networks

Sam H. Haidar, Steven B. Johnson, Michael J. Fossler, Ajaz S. Hussain

Journal:

Pharmaceutical Research

Year:

2002

Language:

english

File:

PDF, 210 KB

english, 2002

4

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

Li, Huafang, Yang, Jiansong, Zhao, Hongxin, Fossler, Michael J., Wang, Chunrong

Journal:

Clinical Pharmacology in Drug Development

Year:

2015

Language:

english

File:

PDF, 481 KB

english, 2015

5

Pharmacokinetics and Pharmacodynamics of Argatroban in Combination With a Platelet Glycoprotein IIB/IIIA Receptor Antagonist in Patients Undergoing Percutaneous Coronary Intervention

Cox, Donna S., Kleiman, Neal S., Boyle, Duane A., Aluri, Jagadeesh, Parchman, L. Gerald, Holdbrook, Frederick, Fossler, Michael J.

Journal:

Journal of Clinical Pharmacology

Year:

2004

Language:

english

File:

PDF, 341 KB

english, 2004

6

Impact of Formulation on the Pharmacokinetics of Dutasteride: Results from Two Phase I Studies

Fossler, Michael, Zhu, John, Roehrborn, Claus, McAleese, Paul, Manyak, Michael

Journal:

Clinical Drug Investigation

Year:

2016

Language:

english

File:

PDF, 567 KB

english, 2016

7

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

Nafziger, Anne N., Arscott, Kelly A., Cochrane, Kristina, Skobieranda, Franck, Burt, David A., Fossler, Michael J.

Journal:

Clinical Pharmacology in Drug Development

Year:

2019

File:

PDF, 527 KB

2019

8

829 Ribavirin Population Pharmacokinetics in African American and Caucasian American Patients Infected with Chronic Hepatitis C Genotype 1

Jin, Runyan, Fossler, Michael J., Dowling, Thomas, Howell, Charles D.

Journal:

Gastroenterology

Year:

2009

Language:

english

File:

PDF, 87 KB

english, 2009

9

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

Thornton, Steven, Miller, Hugh, Valenzuela, Guillermo, Snidow, Jerry, Stier, Brendt, Fossler, Michael J., Montague, Timothy H., Powell, Marcy, Beach, Kathleen J.

Journal:

British Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 1013 KB

english, 2015

10

Clinical pharmacology, creating current and future success in drug development

Rogge, Mark C., Dresser, Mark, Fossler, Michael, Heald, Donald, Stoch, S. Aubrey, Vanevski, Konstantina M., Bello, Akintunde

Journal:

Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 133 KB

english, 2015

11

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.

Journal:

Journal of Clinical Pharmacology

Year:

2008

Language:

english

File:

PDF, 618 KB

english, 2008

12

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

Kemp, Matthew W., Saito, Masatoshi, Usuda, Haruo, Molloy, Timothy J., Miura, Yuichiro, Sato, Shinichi, Watanabe, Shimpei, Clarke, Michael, Fossler, Michael, Scmidt, Augusto, Kallapur, Suhas G., Kramer

Journal:

American Journal of Obstetrics and Gynecology

Year:

2016

Language:

english

File:

PDF, 1.16 MB

english, 2016

13

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

James W. Hainer, Donald J. Sherrard, Suzanne K. Swan, Jeffrey S. Barrett, Christopher A. Assaid, Michael J. Fossler, Donna S. Cox, Robert M. Williams, Amy L. Pittenger, Carol A. Stephenson, Tsushung A

Journal:

American Journal of Kidney Diseases

Year:

2002

Language:

english

File:

PDF, 57 KB

english, 2002

14

A systematic evaluation of effect of adherence patterns on the sample size and power of a clinical study

Mallayasamy, Surulivelrajan, Chaturvedula, Ayyappa, Blaschke, Terrence, Fossler, Michael J

Journal:

CPT: Pharmacometrics & Systems Pharmacology

Year:

2018

Language:

english

File:

PDF, 747 KB

english, 2018

15

Population Pharmacokinetics and Pharmacodynamics of Ribavirin in Patients with Chronic Hepatitis C Genotype 1 Infection

Jin, Runyan, Fossler, Michael J., McHutchison, John G., Howell, Charles D., Dowling, Thomas C.

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 437 KB

english, 2012

16

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, JÃ¶rg, Baltezor, Mike, Macheras, Panos, Khan, Mansoor,

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 1016 KB

english, 2013

17

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

Chaturvedula, Ayyappa, Fossler, Michael J., Hendrix, Craig W.

Journal:

Journal of Clinical Pharmacology

Year:

2014

Language:

english

File:

PDF, 551 KB

english, 2014

18

Effect of Retosiban on Cardiac Repolarization in a Randomized, Placebo- and Positive-controlled, Crossover Thorough QT/QTc Study in Healthy Men and Women

Stier, Brendt, Fossler, Michael, Liu, Feng, Caltabiano, Stephen

Journal:

Clinical Therapeutics

Year:

2015

Language:

english

File:

PDF, 327 KB

english, 2015

19

Population pharmacokinetics of S(−)-carvedilol in healthy volunteers after administration of the immediate-release (IR) and the new controlled-release (CR) dosage forms of the racemate

Ahmed A. Othman, David M. Tenero, Duane A. Boyle, Natalie D. Eddington, Michael J. Fossler

Journal:

The AAPS Journal

Year:

2007

Language:

english

File:

PDF, 707 KB

english, 2007

20

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

Thornton, Steven, Valenzuela, Guillermo, Baidoo, Charlotte, Fossler, Michael J., Montague, Timothy H., Clayton, Linda, Powell, Marcy, Snidow, Jerry, Stier, Brendt, Soergel, David

Journal:

British Journal of Clinical Pharmacology

Year:

2017

Language:

english

File:

PDF, 456 KB

english, 2017

21

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.

Journal:

Frontiers in Pharmacology

Year:

2019

Language:

english

File:

PDF, 1.42 MB

english, 2019

22

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.

Journal:

Clinical Drug Investigation

Year:

2020

File:

PDF, 1.46 MB

2020

23

Edible Cannabis Products: It Is Time for FDA Oversight

Benjamin, David M., Fossler, Michael J.

Journal:

Journal of Clinical Pharmacology

Year:

2016

Language:

english

File:

PDF, 302 KB

english, 2016

24

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.

Journal:

Journal of Clinical Pharmacology

Year:

2018

Language:

english

File:

PDF, 971 KB

english, 2018

25

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, Gengqian, Thiessen, Jake J., Baidoo, Charlotte A., Fossler, Michael J.

Journal:

Journal of Clinical Pharmacology

Year:

2010

Language:

english

File:

PDF, 266 KB

english, 2010

26

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

Journal:

Journal of Clinical Pharmacology

Year:

2019

Language:

english

File:

PDF, 436 KB

english, 2019

27

Patient adherence: Clinical pharmacology's embarrassing relative

Fossler, Michael J.

Journal:

Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 291 KB

english, 2015

28

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

Barbour, April M., Magee, Mindy, Shaddinger, Bonnie, Arya, Niki, Tombs, Lee, Tao, Wenli, Patel, Bela R., Fossler, Michael J., Glaser, Ruchira

Journal:

Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 508 KB

english, 2015

29

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

James, Ian E., Skobieranda, Franck, Soergel, David G., Ramos, Kimberly A., Ruff, Dennis, Fossler, Michael J.

Journal:

Clinical Pharmacology in Drug Development

Year:

2019

Language:

english

File:

PDF, 815 KB

english, 2019

30

Population pharmacokinetics of tenofovir in HIV-1 uninfected members of sero-discordant couples and effect of dose reporting methods

Lu, Yanhui, Goti, Vineet, Chaturvedula, Ayyappa, Haberer, Jessica E., Fossler, Michael J., Sale, Mark E, Bangsberg, David, Baeten, Jared M., Celum, Connie L., Hendrix, Craig W.

Journal:

Antimicrobial Agents and Chemotherapy

Year:

2016

Language:

english

File:

PDF, 1.67 MB

english, 2016

31

Identification of Formulation and Manufacturing Variables That Influence In Vitro Dissolution and In Vivo Bioavailability of Propranolol Hydrochloride Tablets

Eddington, Natalie D., Ashraf, Muhammad, Augsburger, Larry L., Leslie, James L., Fossler, Michael J., Lesko, Lawrence J., Shah, Vinod P., Rekhi, Gurvinder Singh

Journal:

Pharmaceutical Development and Technology

Year:

1998

Language:

english

File:

PDF, 878 KB

english, 1998

32

Dosing in Heavy-weight/Obese Patients with the LMWH, Tinzaparin: A Pharmacodynamic Study

Hainer, James, Barrett, Jeffrey, Assaid, Christopher, Fossler, Michael, Cox, Donna, Leathers, Todd, Leese, Philip

Journal:

Thrombosis and Haemostasis

Year:

2002

Language:

english

File:

PDF, 355 KB

english, 2002

33

Practical Considerations for Dose Selection in Pediatric Patients to Ensure Target Exposure Requirements

Barbour, April M., Fossler, Michael J., Barrett, Jeffrey

Journal:

The AAPS Journal

Year:

2014

Language:

english

File:

PDF, 627 KB

english, 2014

34

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

Madrasi, Kumpal, Chaturvedula, Ayyappa, Haberer, Jessica E., Sale, Mark, Fossler, Michael J., Bangsberg, David, Baeten, Jared M., Celum, Connie, Hendrix, Craig W.

Journal:

Journal of Clinical Pharmacology

Year:

2017

Language:

english

File:

PDF, 687 KB

english, 2017

35

Some Thoughts About the Mean Concentration-Versus-Time Plot

Fossler, Michael J.

Journal:

Clinical Pharmacology in Drug Development

Year:

2017

Language:

english

File:

PDF, 501 KB

english, 2017

36

A Phase I, Randomized, SingleâBlind, PlaceboâControlled, 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.

Journal:

Year:

2020

File:

PDF, 1.07 MB

2020

37

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

Barbour, April M., Fossler, Michael J.

Journal:

Journal of Clinical Pharmacology

Year:

2017

Language:

english

File:

PDF, 288 KB

english, 2017

38

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, Soergel, David, Burt, David, Subach, Ruth Ann, Salamea, Monica, Fossler, Michael, Skobieranda, Franck

Journal:

Journal of Pain Research

Year:

2017

Language:

english

File:

PDF, 393 KB

english, 2017

39

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

Nafziger, Anne N., Arscott, Kelly A., Cochrane, Kristina, Skobieranda, Franck, Burt, David A., Fossler, Michael J.

Journal:

Clinical Pharmacology in Drug Development

Year:

2019

Language:

english

File:

PDF, 527 KB

english, 2019

40

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

Divya Menon-Andersen, John T. Mondick, Bhuvana Jayaraman, Patrick A. Thompson, Susan M. Blaney, Mark Bernstein, Mason Bond, Martin Champagne, Michael J. Fossler, Jeffrey S. Barrett

Journal:

Cancer Chemotherapy and Pharmacology

Year:

2009

Language:

english

File:

PDF, 873 KB

english, 2009

41

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

Barbour, April M., Sarov-Blat, Lea, Cai, Gengqian, Fossler, Michael J., Sprecher, Dennis L., Graggaber, Johann, McGeoch, Adam T., Maison, Jo, Cheriyan, Joseph

Journal:

British Journal of Clinical Pharmacology

Year:

2013

Language:

english

File:

PDF, 528 KB

english, 2013

42

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

Lepore, John J., Olson, Eric, Demopoulos, Laura, Haws, Thomas, Fang, Zixing, Barbour, April M., Fossler, Michael, Davila-Roman, Victor G., Russell, Stuart D., Gropler, Robert J.

Journal:

Journal of the American College of Cardiology: Heart Failure

Year:

2016

Language:

english

File:

PDF, 355 KB

english, 2016

43

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

Brighton, Paul J, Fossler, Michael J, Quenby, Siobhan, Blanks, Andrew M

Journal:

Year:

2020

Language:

english

File:

PDF, 2.62 MB

english, 2020

44

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

Pieniaszek, Henry J., Sy, Sherwin K. B., Ebling, William, Fossler, Michael J., Cain, Valerie A., Mondick, John T., Ma, Su, Kornhauser, David M.

Journal:

Journal of Clinical Pharmacology

Year:

2002

Language:

english

File:

PDF, 171 KB

english, 2002

45

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.

Journal:

Journal of Clinical Pharmacology

Year:

2018

Language:

english

File:

PDF, 940 KB

english, 2018

46

Globalization of Quantitative Pharmacology: First International Symposium of Quantitative Pharmacology in Drug Development and Regulation

Barrett, Jeffrey S., Shi, Jun, Xie, Hai-Tang, Huang, Xiao-Hui, Fossler, Michael J., Sun, Rui-Yuan

Journal:

Journal of Clinical Pharmacology

Year:

2008

Language:

english

File:

PDF, 71 KB

english, 2008

47

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

Beard, Timothy L., Michalsky, Cathy, Candiotti, Keith A., Rider, Paul, Wase, Linda, Habib, Ashraf S., Demitrack, Mark A., Fossler, Michael J., Viscusi, Eugene R.

Journal:

Pain and Therapy

Year:

2020

File:

PDF, 611 KB

2020

48

Corrigendum: Population pharmacokinetics of S(-)-carvedilol in healthy volunteers after administration of the immediate-release (IR) and the new controlled-release (CR) dosage forms of the racemate

Ahmed A. Othman, David M. Tenero, Duane A. Boyle, Natalie D. Eddington, Michael J. Fossler

Journal:

The AAPS Journal

Year:

2007

Language:

english

File:

PDF, 527 KB

english, 2007

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