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1 . Academic Journal
When can real‐world data generate real‐world evidence?
저자
by
Rahman, Motiur
;
Dal Pan, Gerald
;
Stein, Peter
;
Levenson, Mark
;
Kraus, Stefanie
, et al.
소스
Pharmacoepidemiology & Drug Safety; Jan2024, Vol. 33 Issue 1, p1-4, 4p
Web of Science
Scopus
JCR 저널정보
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7 . Academic Journal
Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development.
저자
by
Levenson, Mark
;
He, Weili
;
Chen, Li
;
Dharmarajan, Sai
;
Izem, Rima
, et al.
소스
Statistics in Biopharmaceutical Research
. Jul-Sep2023, Vol. 15 Issue 3, p689-696. 8p.
Web of Science
Scopus
JCR 저널정보
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7 . Academic Journal
The Use of Machine Learning in Regulatory Drug Safety Evaluation.
저자
by
Zhang, Di
;
Song, Jaejoon
;
Dharmarajan, Sai
;
Jung, Tae Hyun
;
Lee, Hana
, et al.
소스
Statistics in Biopharmaceutical Research
. Jul-Sep2023, Vol. 15 Issue 3, p519-523. 5p.
Web of Science
Scopus
JCR 저널정보
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7 . Academic Journal
Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment.
저자
by
Levenson, Mark
;
He, Weili
;
Chen, Jie
;
Fang, Yixin
;
Faries, Douglas
, et al.
소스
Statistics in Biopharmaceutical Research
. Jan-Mar2023, Vol. 15 Issue 1, p3-13. 11p.
Web of Science
Scopus
JCR 저널정보
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7 . Academic Journal
Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety
저자
by
Pinheiro, Simone P.
;
Rivera, Donna R.
;
Graham, David J.
;
Freedman, Andrew N.
;
Major, Jacqueline M.
, et al.
소스
In
Annals of Epidemiology
November 2016 26(11):735-740
Full Text (Clinical Key)
Full Text (ScienceDirect)
Web of Science
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7 . Academic Journal
University of Pennsylvania 12th annual conference on statistical issues in clinical trials: Electronic health records in randomized clinical trials—challenges and opportunities (morning panel session).
저자
by
Esserman, Denise
;
Goldstein, Benjamin A
;
Levenson, Mark
;
Platt, Richard
;
Roe, Matthew T
, et al.
소스
Clinical Trials; Aug2020, Vol. 17 Issue 4, p405-413, 9p, 1 Chart
Web of Science
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7 . Academic Journal
Nonrandomized Real‐World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project.
저자
by
Franklin, Jessica M.
;
Pawar, Ajinkya
;
Martin, David
;
Glynn, Robert J.
;
Levenson, Mark
, et al.
소스
Clinical Pharmacology & Therapeutics; Apr2020, Vol. 107 Issue 4, p817-826, 10p
Web of Science
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7 . Academic Journal
Rejoinder to the Commentaries on "The Current Landscape in Biostatistics of Real-World Data and Evidence: Label Expansion".
저자
by
Levenson, Mark
;
He, Weili
.
소스
Statistics in Biopharmaceutical Research
. Jan-Mar2023, Vol. 15 Issue 1, p27-28. 2p.
Web of Science
Scopus
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4 . Periodical
FINAL BLOW.
저자
by
Levenson, Mark
.
소스
Mystery Magazine; Sep2021, p86-88, 3p
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3 . Academic Journal
Sources of Safety Data and Statistical Strategies for Design and Analysis.
저자
by
Marchenko, Olga
;
Russek-Cohen, Estelle
;
Levenson, Mark
;
Zink, Richard C.
;
Krukas-Hampel, Michelle R.
, et al.
소스
Therapeutic Innovation & Regulatory Science; Mar2018, Vol. 52 Issue 2, p170-186, 17p
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