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1

Relationship between International Normalized Ratio and Outcomes in Modern Trials with Warfarin Controls

McDowell, Tzu-Yun, Lawrence, John, Florian, Jeffry, Southworth, Mary Ross, Grant, Stephen, Stockbridge, Norman

Journal:

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Year:

2018

Language:

english

File:

PDF, 533 KB

english, 2018

2

Effect of Body Weight on Risk‐Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis

Lee, Jee Eun, Wang, Jie, Florian, Jeffry, Wang, Yow‐Ming, Kettl, David, Marcus, Kendall, Woitach, Amy

Journal:

Clinical Pharmacology & Therapeutics

Year:

2019

Language:

english

File:

PDF, 297 KB

english, 2019

3

Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients

Matta, Murali K., Florian, Jeffry, Zusterzeel, Robbert, Pilli, Nageswara R., Patel, Vikram, Volpe, Donna A., Yang, Yang, Oh, Luke, Bashaw, Edward, Zineh, Issam, Sanabria, Carlos, Kemp, Sarah, Godfrey,

Journal:

Year:

2020

Language:

english

File:

PDF, 634 KB

english, 2020

4

Nonlinear model predictive control for dosing daily anticancer agents using a novel saturating-rate cell-cycle model

Jeffry A. Florian Jr., Julie L. Eiseman, Robert S. Parker

Journal:

Computers in Biology and Medicine

Year:

2008

Language:

english

File:

PDF, 686 KB

english, 2008

5

Plasma pharmacokinetics and oral bioavailability of 3,4,5,6-tetrahydrouridine, a cytidine deaminase inhibitor, in mice

Jan H. Beumer, Julie L. Eiseman, Robert A. Parise, Jeffry A. Florian, Erin Joseph, David Z. D’Argenio, Robert S. Parker, Brittany Kay, Joseph M. Covey, Merrill J. Egorin

Journal:

Cancer Chemotherapy and Pharmacology

Year:

2008

Language:

english

File:

PDF, 401 KB

english, 2008

6

Measurements of NH3 and CO2 with Distributed-Feedback Diode Lasers Near 2.0 μm in Bioreactor Vent Gases

Webber, Michael E., Claps, Ricardo, Englich, Florian V., Tittel, Frank K., Jeffries, Jay B., Hanson, Ronald K.

Journal:

Year:

2001

Language:

english

File:

PDF, 211 KB

english, 2001

7

Diminished Gray Matter Within the Hypothalamus in Autism Disorder: A Potential Link to Hormonal Effects?

Florian Kurth, Katherine L. Narr, Roger P. Woods, Joseph O'Neill, Jeffry R. Alger, Rochelle Caplan, James T. McCracken, Arthur W. Toga, Jennifer G. Levitt

Journal:

Biological Psychiatry

Year:

2011

Language:

english

File:

PDF, 297 KB

english, 2011

8

Gastroesophageal Reflux Disease–Associated Esophagitis Induces Endogenous Cytokine Production Leading to Motor Abnormalities

Florian Rieder, Ling Cheng, Karen M. Harnett, Amitabh Chak, Gregory S. Cooper, Gerard Isenberg, Monica Ray, Jeffry A. Katz, Andrew Catanzaro, Robert O’Shea, Anthony B. Post, Richard Wong, Michael V. S

Journal:

Gastroenterology

Year:

2007

Language:

english

File:

PDF, 963 KB

english, 2007

9

Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies

Chen, Jianmeng, Florian, Jeffry, Carter, Wendy, Fleischer, Russell D., Hammerstrom, Thomas S., Jadhav, Pravin R., Zeng, Wen, Murray, Jeffrey, Birnkrant, Debra

Journal:

Gastroenterology

Year:

2013

Language:

english

File:

PDF, 411 KB

english, 2013

10

Don't Get Boxed In: Commentary on the Visual Inspection Practices to Assess Exposure-Response Relationships From Binary Clinical Variables

Mehrotra, Shailly, Jr, Jeffry Florian, Gobburu, Jogarao

Journal:

Journal of Clinical Pharmacology

Year:

2012

Language:

english

File:

PDF, 623 KB

english, 2012

11

Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies

Florian, Jeffry A., Tornøe, Christoffer W., Brundage, Richard, Parekh, Ameeta, Garnett, Christine E.

Journal:

Journal of Clinical Pharmacology

Year:

2011

Language:

english

File:

PDF, 292 KB

english, 2011

12

FDA Perspective on Sofosbuvir Therapy for Patients With Chronic Hepatitis C Virus Genotype 1 Infection Who Did Not Respond to Treatment With Pegylated Interferon and Ribavirin

Mishra, Poonam, Florian, Jeffry, Qi, Karen, Zeng, Wen, Naeger, Lisa K., Donaldson, Eric, Connelly, Sarah, O’Rear, Jules, Price, Dionne, Murray, Jeffrey, Birnkrant, Debra

Journal:

Gastroenterology

Year:

2014

Language:

english

File:

PDF, 317 KB

english, 2014

13

Does an Increase in Serum Creatinine always Reflect Renal Injury? The Case of Stribild®

Arya, Vikram, Florian, Jeffry, Marcus, Kendall A., Reynolds, Kellie S., Lewis, Linda L., Sherwat, Adam I.

Journal:

Journal of Clinical Pharmacology

Year:

2014

Language:

english

File:

PDF, 138 KB

english, 2014

14

Creation of a Knowledge Management System for QT Analyses

Tornøe, Christoffer W., Garnett, Christine E., Wang, Yaning, Florian, Jeffry, Li, Michael, Gobburu, Jogarao V.

Journal:

Journal of Clinical Pharmacology

Year:

2011

Language:

english

File:

PDF, 501 KB

english, 2011

15

Knowledge management for efficient quantitative analyses during regulatory reviews

Krudys, Kevin, Li, Fang, Florian, Jeffry, Tornoe, Christoffer, Chen, Ying, Bhattaram, Atul, Jadhav, Pravin, Neal, Lauren, Wang, Yaning, Gobburu, Joga, Lee, Peter ID

Journal:

Expert Review of Clinical Pharmacology

Year:

2011

Language:

english

File:

PDF, 622 KB

english, 2011

16

Investigation of potential mechanisms of sex differences in quinidine-induced torsade de pointes risk

Vicente, Jose, Simlund, Jacob, Johannesen, Lars, Sundh, Frida, Florian, Jeffry, Ugander, Martin, Wagner, Galen S., Woosley, Raymond L., Strauss, David G.

Journal:

Journal of Electrocardiology

Year:

2015

Language:

english

File:

PDF, 714 KB

english, 2015

17

FDA bridging analyses confirmed in clinical trial

Mishra, Poonam, Florian, Jeffry, Murray, Jeffrey

Journal:

Year:

2014

Language:

english

File:

PDF, 299 KB

english, 2014

18

Boceprevir dosing for late responders and null responders: The role of bridging data between treatment-naïve and -experienced subjects

Florian, Jeffry, Jadhav, Pravin R., Amur, Shashi, Ayala, Ruben, Harrington, Patrick, Mishra, Poonam, O'Rear, Jules, Pacanowski, Michael, Robertson, Sarah, Singer, Mary, Soon, Greg, Zeng, Wen, Murray,

Journal:

Year:

2013

Language:

english

File:

PDF, 607 KB

english, 2013

19

A NONLINEAR DATA–DRIVEN APPROACH TO TYPE I DIABETIC PATIENT MODELING

Florian, Jeffry A., Parker, Robert S.

Journal:

IFAC Proceedings Volumes

Year:

2002

Language:

english

File:

PDF, 194 KB

english, 2002

20

A POPULATION BALANCE MODEL OF CELL CYCLE-SPECIFIC TUMOR GROWTH

Florian, Jeffry A., Parker, Robert S.

Journal:

IFAC Proceedings Volumes

Year:

2005

Language:

english

File:

PDF, 2.35 MB

english, 2005

21

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

Mulugeta, Yeruk, Barrett, Jeffrey S., Nelson, Robert, Eshete, Abel Tilahun, Mushtaq, Alvina, Yao, Lynne, Glasgow, Nicole, Mulberg, Andrew E., Gonzalez, Daniel, Green, Dionna, Florian, Jeffry, Krudys,

Journal:

Journal of Clinical Pharmacology

Year:

2016

Language:

english

File:

PDF, 791 KB

english, 2016

22

A Nonlinear Model Predictive Control Algorithm for Breast Cancer Treatment

Florian, Jeffry A., Eiseman, Julie L., Parker, Robert S.

Journal:

IFAC Proceedings Volumes

Year:

2004

Language:

english

File:

PDF, 16.63 MB

english, 2004

23

Public–Private Partnership: Targeting Real-World Data for Hepatitis C Direct-Acting Antivirals

Mishra, Poonam, Florian, Jeffry, Peter, Joy, Vainorius, Monika, Fried, Michael W., Nelson, David R., Birnkrant, Debra

Journal:

Gastroenterology

Year:

2017

Language:

english

File:

PDF, 1.23 MB

english, 2017

24

Is There A Role For Pharmacokinetic/Pharmacodynamic Guided Dosing For Novel Oral Anticoagulants?

Chan, Noel, Sager, Philip T., Lawrence, Jack, Ortel, Thomas's, Reilly, Paul, Berkowitz, Scott, Kubitza, Dagmar, Eikelboom, John, Florian, Jeffry, Stockbridge, Norman, Rose, Martin, Temple, Robert, Sel

Journal:

American Heart Journal

Year:

2017

Language:

english

File:

PDF, 602 KB

english, 2017

25

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments

Florian, Jeffry, Zhuang, Ada

Journal:

CPT: Pharmacometrics & Systems Pharmacology

Year:

2017

Language:

english

File:

PDF, 80 KB

english, 2017

26

Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism

Khurana, Manoj, Zadezensky, Immo, Lowy, Naomi, Roman, Dragos, Guettier, Jean-Marc, Li, Liang, Florian, Jeffry, Sahajwalla, Chandrahas G., Sinha, Vikram, Mehrotra, Nitin

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 557 KB

english, 2018

27

Assessment of Multi-Ion Channel Block in a Phase-1 Randomized Study Design:Results of the CiPA Phase 1 ECG Biomarker Validation Study

Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Ochoa-Jimenez, Roberto, Mason, Jay W, Sanabria, Carlos, Kemp, Sarah, Sager, Philip T., Patel, Vikram, Matta, Murali K, Liu, Jiang, Florian, Jeffry

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 1.95 MB

english, 2018

28

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Li, Junyi, Florian, Jeffry, Campbell, Elizabeth, Schrieber, Sarah J., Bai, Jane P.F., Weaver, James L., Hyland, Paula L., Thway, Theingi M., Matta, Murali K., Lankapalli, Rachana H., Narayanasamy, Sur

Journal:

Clinical Pharmacology & Therapeutics

Year:

2019

Language:

english

File:

PDF, 204 KB

english, 2019

29

Evaluation of Hemodialysis Effect on Pharmacokinetics of Meropenem/Vaborbactam in EndâStage Renal Disease Patients Using Modeling and Simulation

Zhuang, Luning, Yu, Yichao, Wei, Xiaohui, Florian, Jeffry, Jang, Seong H., Reynolds, Kellie S., Wang, Yaning

Journal:

Journal of Clinical Pharmacology

Year:

2020

Language:

english

File:

PDF, 2.02 MB

english, 2020

30

Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use

Madabushi, Rajanikanth, Pfuma Fletcher, Elimika, Florian, Jeffry, Milligan, Lauren, Ramamoorthy, Anuradha, Yang, Xinning, Maxfield, Kimberly, Sahre, Martina, Jean, Daphney, Zhang, Lei, Green, Dionna,

Journal:

Clinical Pharmacology & Therapeutics

Year:

2020

File:

PDF, 164 KB

2020

31

Thromboembolic and hemorrhagic outcomes in the direct oral anticoagulant trials across the spectrum of kidney function

Limdi, Nita A., Beasley, T. Mark, Sun, Jielin, Stockbridge, Norman, Pacanowski, Michael, Florian, Jeffry

Journal:

Clinical Pharmacology & Therapeutics

Year:

2020

File:

PDF, 12.32 MB

2020

32

3D micro-organisation printing of mammalian cells to generate biological tissues

Jeffries, Gavin D. M., Xu, Shijun, Lobovkina, Tatsiana, Kirejev, Vladimir, Tusseau, Florian, Gyllensten, Christoffer, Singh, Avadhesh Kumar, Karila, Paul, Moll, Lydia, Orwar, Owe

Journal:

Scientific Reports

Year:

2020

File:

PDF, 4.70 MB

2020

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