Safety Data Evaluation

Safety Data Evaluation is a systematic assessment process within the domain of pharmacovigilance and regulatory science that analyzes clinical and non-clinical data to identify, characterize, and interpret adverse events and other safety-related risks associated with a medicinal product, distinguishing it from general efficacy or quality evaluations by focusing exclusively on harm detection and risk-benefit profiling in support of Marketing Authorization Applications.

261

Publications

13.4K

Citations

1.6K

Authors

685

Institutions

Publications per year

2017–2026

113

Parents

Marketing Authorization Applications

Publications

261

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients

A.M. Api, D. Belsito, M. Bruze et al. · Food and Chemical Toxicology · 2014 · 1.9K citations · Full text

Agriculture, Food Science, Food Safety +11

PARAMOUNT: Final Overall Survival Results of the Phase III Study of Maintenance Pemetrexed Versus Placebo Immediately After Induction Treatment With Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

Luis Paz‐Ares, Filippo de Marinis, Mircea Dediu et al. · Journal of Clinical Oncology · 2013 · 635 citations

Medicine, Oncology, Pharmacotherapy +16

Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated <i>BRAF</i> V600E–Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study

Josep Tabernero, Axel Grothey, Eric Van Cutsem et al. · Journal of Clinical Oncology · 2021 · 544 citations · Full text

Medicine, Oncology, Pharmacology +16

The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide

Anne E. Fung, Philip J. Rosenfeld, Elias Reichel · British Journal of Ophthalmology · 2006 · 537 citations · Full text

Pharmacy, Pharmacology, Pharmacotherapy +14

Deaths Related to Liposuction

Rama B. Rao, Susan F. Ely, Robert S. Hoffman · New England Journal of Medicine · 1999 · 355 citations · Full text

Veterinary Medicine, Plastic Surgery, Surgery +11

1–5 of 261

Authors

1.6K

ST
Sengwee Toh
Harvard University, United States
3 publications · 72 citations
3
h-index
HA
H. Amy Xia
Amgen (United States), United States
3 publications · 154 citations
3
h-index
TY
Takayuki Yoshino
National Cancer Center Hospital East, Japan
3 publications · 577 citations
3
h-index
JJ
Joshua J. Gagne
Brigham and Women's Hospital, United States
3 publications · 72 citations
3
h-index
SW
Shirley Wang
Brigham and Women's Hospital, United States
3 publications · 72 citations
3
h-index

1–5 of 1.6K

Institutions

685

1–8 of 685

Venues

PubMed
Repository · 8 publications · 556 citations
8
h-index
Journal of Clinical Oncology
8 publications · 1.3K citations
8
h-index
Pharmacoepidemiology and Drug Safety
7 publications · 172 citations
7
h-index
Expert Opinion on Drug Safety
7 publications · 140 citations
7
h-index
Regulatory Toxicology and Pharmacology
RTP · 6 publications · 304 citations
6
h-index

1–5