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1

Effects of finasteride on health-related quality of life in men with symptomatic benign prostatic hyperplasia

Girman, Cynthia J., Kolman, Christopher, Liss, Charles L., Bolognese, James A., Binkowitz, Bruce S., Stoner, Elizabeth

Journal:

Year:

1996

Language:

english

File:

PDF, 702 KB

english, 1996

2

Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review

Joshua Chen, Hui Quan, Bruce Binkowitz, S. Peter Ouyang, Yoko Tanaka, Gang Li, Shailendra Menjoge, Ekopimo Ibia

Journal:

Pharmaceutical Statistics

Year:

2010

Language:

english

File:

PDF, 223 KB

english, 2010

3

Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials

Chen, J., Zheng, H., Quan, H., Li, G., Gallo, P., Ouyang, S. P., Binkowitz, B., Ting, N., Tanaka, Y., Luo, X., Ibia, E.

Journal:

Clinical Trials

Year:

2013

Language:

english

File:

PDF, 1.30 MB

english, 2013

4

Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials

Quan, Hui, Mao, Xuezhou, Tanaka, Yoko, Binkowitz, Bruce, Li, Gang, Chen, Josh, Zhang, Ji, Zhao, Peng-Liang, Ouyang, Soo Peter, Chang, Mark

Journal:

Contemporary Clinical Trials

Year:

2017

Language:

english

File:

PDF, 412 KB

english, 2017

5

Intra- and interobserver variability of MRI prostate volume measurements

Bonilla, Jaime, Stoner, Elizabeth, Grino, Placido, Binkowitz, Bruce, Taylor, Alice

Journal:

Year:

1997

Language:

english

File:

PDF, 228 KB

english, 1997

6

Ethical considerations in industry-sponsored Multiregional clinical trials

Ekopimo Ibia, Bruce Binkowitz, Jean-Louis Saillot, Steven Talerico, Chin Koerner, Irene Ferreira, Anupam Agarwal, Craig Metz, Marianne Maman

Journal:

Pharmaceutical Statistics

Year:

2010

Language:

english

File:

PDF, 183 KB

english, 2010

7

A model-based approach in the estimation of the maximum tolerated dose in phase I cancer clinical trials

Weili He, Jun Liu, Bruce Binkowitz, Hui Quan

Journal:

Statistics in Medicine

Year:

2006

Language:

english

File:

PDF, 172 KB

english, 2006

8

Disparity in Quantitative Risk Assessment: A Review of Input Distributions

Bruce S. Binkowitz, Daniel Wartenberg

Journal:

Year:

2001

Language:

english

File:

PDF, 176 KB

english, 2001

9

Assessment of systemic effects of different ophthalmic β-blockers in healthy volunteers

Bauer, Karin, Brunner-Ferber, Françoise, Distlerath, Linda M, Lippa, Erik A, Binkowitz, Bruce, Till, Peter, Kaik, Gerhard

Journal:

Clinical Pharmacology & Therapeutics

Year:

1991

Language:

english

File:

PDF, 522 KB

english, 1991

10

P87 Coping with the fast change of medical technology in clinical trials

Bruce S. Binkowitz, Janice M. Weinberg, W.Joe Shih

Journal:

Controlled Clinical Trials

Year:

1993

Language:

english

File:

PDF, 82 KB

english, 1993

11

P113 Evaluating interrater agreement based on categorical scales

Paul Kotey, Audrey Yu, Bruce Binkowitz

Journal:

Controlled Clinical Trials

Year:

1995

Language:

english

File:

PDF, 74 KB

english, 1995

12

PCPT: Evidence That Finasteride Reduces Risk of Most Frequently Detected Intermediate- and High-grade (Gleason Score 6 and 7) Cancer

Steven A. Kaplan, Claus G. Roehrborn, Alan G. Meehan, Kenneth S. Liu, Alexandra D. Carides, Bruce S. Binkowitz, Norman L. Heyden, E. Darracott Vaughan Jr.

Journal:

Year:

2009

Language:

english

File:

PDF, 525 KB

english, 2009

13

Finasteride in the treatment of men with androgenetic alopecia

Keith D. Kaufman, Elise A. Olsen, David Whiting, Ronald Savin, Richard DeVillez, Wilma Bergfeld, Vera H. Price, Dominique Van Neste, Janet L. Roberts, Maria Hordinsky, Jerry Shapiro, Bruce Binkowitz,

Journal:

Journal of the American Academy of Dermatology

Year:

1998

Language:

english

File:

PDF, 724 KB

english, 1998

14

Assessment of bronchial effects following topical administration of butylamino-phenoxy-propanol-acetate, an oculoselective beta- adrenoceptor blocker in asthmatic subjects.

KG Bauer, F Brunner-Ferber, LM Distlerath, EA Lippa, B Binkowitz, P Till, GA Kaik

Journal:

British Journal of Clinical Pharmacology

Year:

1992

Language:

english

File:

PDF, 1.23 MB

english, 1992

15

GUIDELINES FOR MEASUREMENT VALIDATION IN CLINICAL TRIAL DESIGN

Sanchez, M. Matilde, Binkowitz, Bruce S.

Journal:

Journal of Biopharmaceutical Statistics

Year:

1999

Language:

english

File:

PDF, 218 KB

english, 1999

16

Using Repeated Measures of Symptom Score, Uroflowmetry and Prostate Specific Antigen in the Clinical Management of Prostate Disease

Barry, Michael J., Girman, Cynthia J., O'Leary, Michael P., Walker-Corkery, Elizabeth S., Binkowitz, Bruce S., Cockett, Abraham T.K., Guess, Harry A.

Journal:

The Journal of Urology

Year:

1995

Language:

english

File:

PDF, 593 KB

english, 1995

17

Clinical and Biological Characteristics of Familial Benign Prostatic Hyperplasia

Sanda, Martin G., Doehring, Christopher B., Binkowitz, Bruce, Beaty, Terri H., Partin, Alan W., Hale, Erika, Stoner, Elizabeth, Walsh, Patrick C.

Journal:

The Journal of Urology

Year:

1997

Language:

english

File:

PDF, 520 KB

english, 1997

18

Abstract: P1390 DESIGN OF THE DEFINE TRIAL: DETERMINING THE EFFICACY AND TOLERABILITY OF CETP INHIBITION WITH ANACETRAPIB

Cannon, C, Dansky, H, Davidson, M, Gotto, A, Brinton, E, Gould, A, Stepanavage, M, Liu, S, Shah, S, Rubino, J, Gibbons, P, Hermanowski-Vosatka, A, Binkowitz, B, Mitchel, Y, Barter, P

Journal:

Atherosclerosis Supplements

Year:

2009

Language:

english

File:

PDF, 78 KB

english, 2009

19

Decision rule based multiplicity adjustment strategy

Chen, Xun, Capizzi, Tom, Binkowitz, Bruce, Quan, Hui, Wei, Lynn, Luo, Xiaohui

Journal:

Clinical Trials

Year:

2005

Language:

english

File:

PDF, 1.26 MB

english, 2005

20

Multi-regional clinical trial design and consistency assessment of treatment effects

Quan, Hui, Mao, Xuezhou, Chen, Joshua, Shih, Weichung Joe, Ouyang, Soo Peter, Zhang, Ji, Zhao, Peng-Liang, Binkowitz, Bruce

Journal:

Statistics in Medicine

Year:

2014

Language:

english

File:

PDF, 816 KB

english, 2014

21

Guest Editors’ Note: Special Issue Associated With the 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop

Binkowitz, Bruce, Yue, Lilly Q.

Journal:

Journal of Biopharmaceutical Statistics

Year:

2014

Language:

english

File:

PDF, 102 KB

english, 2014

22

Proceedings of the DIA Workshop on Multiregional Clinical Trials, October 26-27, 2010

Ibia, E. O., Binkowitz, B.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2011

Language:

english

File:

PDF, 14.70 MB

english, 2011

23

An adaptive strategy for assessing regional consistency in multiregional clinical trials

Chen, J., Quan, H., Gallo, P., Ouyang, S. P., Binkowitz, B.

Journal:

Clinical Trials

Year:

2012

Language:

english

File:

PDF, 463 KB

english, 2012

24

The Progression and Integration of the Statistical Canda at Merck

Bauer, N., Binkowitz, B., Bidlack, W.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

1993

Language:

english

File:

PDF, 709 KB

english, 1993

25

Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials

Quan, H., Li, M., Chen, J., Gallo, P., Binkowitz, B., Ibia, E., Tanaka, Y., Ouyang, S. P., Luo, X., Li, G., Menjoge, S., Talerico, S., Ikeda, K.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2010

Language:

english

File:

PDF, 16.75 MB

english, 2010

26

Effect on the 24-hour diurnal curve of intraocular pressure of a fixed ratio combination of timolol 0.5% and pilocarpine 2% in patients with COAG not controlled on timolol 0.5%.

Maclure, G M, Vogel, R, Sturm, A, Binkowitz, B

Journal:

British Journal of Ophthalmology

Year:

1989

Language:

english

File:

PDF, 636 KB

english, 1989

27

Pre-study feasibility and identifying sensitivity analyses for protocol pre-specification in comparative effectiveness research

Girman, Cynthia J, Faries, Douglas, Ryan, Patrick, Rotelli, Matt, Belger, Mark, Binkowitz, Bruce, O’Neill, Robert

Journal:

Journal of Comparative Effectiveness Research

Year:

2014

Language:

english

File:

PDF, 1.98 MB

english, 2014

28

Defining Regions in Multiregional Clinical Trials: An Analytical Approach to Considering Impact of Intrinsic and Extrinsic Factors

Y. Tanaka, A. Buchanan, S. Lipsius, E. O. Ibia, M. Rabbia, B. Binkowitz

Year:

2015

Language:

english

File:

PDF, 216 KB

english, 2015

29

C282. Median versus geometric mean for lognormal samples

Shih, W. J., Binkowitz, Bruce

Journal:

Journal of Statistical Computation and Simulation

Year:

1987

Language:

english

File:

PDF, 254 KB

english, 1987

30

Results of a Survey of PhRMA Member Companies on Practices Associated with Multiregional Clinical Trials

Scott, Nick, Binkowitz, Bruce, Ibia, Ekopimo Okon, Houck, Tonya, Field, Belinda, Talerico, Steven D., Tanaka, Yoko, Lee, Andy

Journal:

Drug Information Journal

Year:

2011

Language:

english

File:

PDF, 742 KB

english, 2011

31

Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 2: Monitoring, Reporting, and Interpretation

Gallo, Paul, Chen, Joshua, Quan, Hui, Menjoge, Shailendra, Luo, Xiaolong, Tanaka, Yoko, Li, Gang, Ouyang, S. Peter, Binkowitz, Bruce, Ibia, Ekopimo, Talerico, Steven, Ikeda, Kimitoshi

Journal:

Drug Information Journal

Year:

2011

Language:

english

File:

PDF, 561 KB

english, 2011

32

Multiregional Clinical Trials: An Introduction from an Industry Perspective

Binkowitz, Bruce, Ibia, Ekopimo

Journal:

Drug Information Journal

Year:

2011

Language:

english

File:

PDF, 529 KB

english, 2011

33

Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 1: Design Considerations

Chen, Joshua, Quan, Hui, Gallo, Paul, Menjoge, Shailendra, Luo, Xiaolong, Tanaka, Yoko, Li, Gang, Ouyang, S. Peter, Binkowitz, Bruce, Ibia, Ekopimo, Talerico, Steven, Ikeda, Kimitoshi

Journal:

Drug Information Journal

Year:

2011

Language:

english

File:

PDF, 624 KB

english, 2011

34

Points to Consider in Defining Region for a Multiregional Clinical Trial: Defining Region Work Stream in PhRMA MRCT Key Issue Team

Tanaka, Yoko, Mak, Carmen, Burger, Brent, Ibia, Ekopimo Okon, Rabbia, Michael, Chen, Joshua, Zolotovitski, Alex, Binkowitz, Bruce

Journal:

Drug Information Journal

Year:

2011

Language:

english

File:

PDF, 997 KB

english, 2011

35

A Fixed Combination of Timolol and Pilocarpine

Sturm, A., Vogel, Roger, Binkowitz, B.

Journal:

Journal of Glaucoma

Year:

1992

File:

PDF, 510 KB

1992

36

Effect of Nissen Fundoplication on Gastric Motor and Sensory Functions

Mousa, Hayat, Caniano, Donna A., Alhajj, Maya, Gibson, Laurie, Di Lorenzo, Carlo, Binkowitz, Larry

Journal:

Journal of Pediatric Gastroenterology & Nutrition

Year:

2006

Language:

english

File:

PDF, 112 KB

english, 2006

37

Statistical planning to address strongly correlated endpoints for inferential subgroups: An innovative approach for an illustrative clinical trial with complex multiplicity issues

Sun, Hengrui, Binkowitz, Bruce, Koch, Gary G

Journal:

Journal of Biopharmaceutical Statistics

Year:

2017

Language:

english

File:

PDF, 1.54 MB

english, 2017

38

Assessing Treatment Effects That Capture Disease Burden in Serious Chronic Diseases

Akacha, Mouna, Binkowitz, Bruce, Claggett, Brian, Hung, H. M. James, Mueller-Velten, Guenther, Stockbridge, Norman

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2018

Language:

english

File:

PDF, 242 KB

english, 2018

39

Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity

Li, Gang, Quan, Hui, Lan, Gordon, Ouyang, Soo Peter, Chen, Fei, Robieson, Weining, Wang, William, Binkowitz, Bruce, Yuan, Shuai Sammy, Tanaka, Yoko, Chen, Josh, Matsuoka, Nobushige, Zhang, Lanju, Yang

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2018

Language:

english

File:

PDF, 324 KB

english, 2018

40

P113 Evaluating interrater agreement based on categorical scales

KOTEY, P, YU, A, BINKOWITZ, B

Journal:

Controlled Clinical Trials

Year:

1995

Language:

english

File:

PDF, 74 KB

english, 1995

41

Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens – The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study

Bassetti, Matteo, Ariyasu, Mari, Binkowitz, Bruce, Nagata, Tsutae Den, Echols, Roger M., Matsunaga, Yuko, Toyoizumi, Kiichiro, Doi, Yohei

Journal:

Infection and Drug Resistance

Year:

2019

File:

PDF, 520 KB

2019

42

Scandinavian Clinical Study of Finasteride in the Treatment of Benign Prostatic Hyperplasia

Beisland, H.O., Binkowitz, B., Brekkan, E., Ekman, P., Kontturi, M., Lehtonen, T., Lundmo, P., Pappas, F., Round, E., Shapiro, D., Stoner, E., Swartz, R., Varenhorst, E.

Journal:

European Urology

Year:

1992

File:

PDF, 768 KB

1992

43

Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity

Li, Gang, Quan, Hui, Lan, Gordon, Ouyang, Soo Peter, Chen, Fei, Robieson, Weining, Wang, William, Binkowitz, Bruce, Yuan, Shuai Sammy, Tanaka, Yoko, Chen, Josh, Matsuoka, Nobushige, Zhang, Lanju, Yang

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2020

File:

PDF, 378 KB

2020

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