Shahrul Mt-Isa
Overview
Explore the profile of Shahrul Mt-Isa including associated specialties, affiliations and a list of published articles.
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37
Citations
1367
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Recent Articles
11.
Laursen M, Hallgreen C, Dreyer N, Bourke A, Mt-Isa S, Blackburn S
Pharmacoepidemiol Drug Saf
. 2019 Dec;
29(3):328-336.
PMID: 31811680
No abstract available.
12.
Li K, Luo S, Yuan S, Mt-Isa S
Stat Med
. 2019 Apr;
38(16):3040-3052.
PMID: 30989691
In existing benefit-risk assessment (BRA) methods, benefit and risk criteria are usually identified and defined separately based on aggregated clinical data and therefore ignore the individual-level differences as well as...
13.
Li K, Yuan S, Wang W, Wan S, Ceesay P, Heyse J, et al.
Contemp Clin Trials
. 2018 Mar;
67:100-108.
PMID: 29505866
Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement...
14.
Wilhelm-Benartzi C, Mt-Isa S, Fiorentino F, Brown R, Ashby D
Crit Rev Oncol Hematol
. 2017 Jan;
110:49-61.
PMID: 28109405
Biomarkers can be used to establish more homogeneous groups using the genetic makeup of the tumour to inform the selection of treatment for each individual patient. However, proper preclinical work...
15.
Richardson J, Stephens S, Thomas S, Jamry-Dziurla A, de Jong-van den Berg L, Zetstra-van der Woude P, et al.
JMIR Public Health Surveill
. 2016 May;
2(1):e13.
PMID: 27227148
Background: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able...
16.
Dreyer N, Blackburn S, Mt-Isa S, Richardson J, Thomas S, Laursen M, et al.
JMIR Public Health Surveill
. 2016 May;
1(2):e22.
PMID: 27227140
Background: Little is known about the effects of human fetal exposure when a new drug is authorized unless it was specifically developed for use in pregnancy. Since many factors may...
17.
Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey G, et al.
Pharmacoepidemiol Drug Saf
. 2016 Jan;
25(3):251-62.
PMID: 26800458
Purpose: The purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies...
18.
Hallgreen C, Mt-Isa S, Lieftucht A, Phillips L, Hughes D, Talbot S, et al.
Pharmacoepidemiol Drug Saf
. 2015 Nov;
25(3):238-50.
PMID: 26521865
Background: The PROTECT Benefit-Risk group is dedicated to research in methods for continuous benefit-risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods....
19.
Mt-Isa S, Ouwens M, Robert V, Gebel M, Schacht A, Hirsch I
Pharm Stat
. 2015 May;
15(4):324-32.
PMID: 25981683
Introduction The conduct of structured benefit-risk assessment (BRA) of pharmaceutical products is a key area of interest for regulatory agencies and the pharmaceutical industry. However, the acceptance of a standardized...
20.
Dreyer N, Blackburn S, Hliva V, Mt-Isa S, Richardson J, Jamry-Dziurla A, et al.
JMIR Med Inform
. 2015 Apr;
3(2):e18.
PMID: 25881627
Obtaining data without the intervention of a health care provider represents an opportunity to expand understanding of the safety of medications used in difficult-to-study situations, like the first trimester of...