Regulatory Science

Regulatory Science is an applied scientific discipline that develops and applies evidence-based methodologies for rigorous evaluation of medical technologies and therapeutics to support regulatory approval and oversight.

Publications

129.2K

Citations

7.9K

Authors

2.6K

Institutions

Publications per year

2017–2026

961

Variants

Regulatory Sciences

Parents

Translational Sciences

Children

Benefit-risk AssessmentBenefit-risk EvaluationDevice RegulationInternational Regulatory HarmonizationPost-market SurveillancePostmarket SurveillanceProduct RegistrationRegulationRegulatory EthicsRegulatory Policy Analysis

Publications

Method for detection of specific RNAs in agarose gels by transfer to diazobenzyloxymethyl-paper and hybridization with DNA probes.

James C. Alwine, Darrell J. Kemp, George R. Stark · Proceedings of the National Academy of Sciences · 1977 · 2.3K citations · Full text

Natural Resources, Environmental Sciences, Regulatory Science +13

The fifth branch: science advisers as policymakers

Choice Reviews Online · 1991 · 1.6K citations

Public Affairs, Public Policy, Regulatory Policy +17

Why a Right to Explanation of Automated Decision-Making Does Not Exist in the General Data Protection Regulation

Sandra Wachter, Brent Mittelstadt, Luciano Floridi · International Data Privacy Law · 2017 · 1.1K citations · Full text

Law, Administrative Law, Regulatory Policy +14

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Stan Benjamens, Pranavsingh Dhunnoo, Bertalan Meskó · npj Digital Medicine · 2020 · 1.1K citations · Full text

Computing, Computer Science, Artificial Intelligence +9

Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. Part 2: General Principles

EFSA Journal · 2009 · 988 citations · Full text

Pharmacy, Risk Management, Regulatory Science +13

1–5 of 3K

Authors

7.9K

AS
Aaron S. Kesselheim
Brigham and Women's Hospital, United States
28 publications · 1.6K citations
18
h-index
JA
John Abraham
University of Maryland, Baltimore, United States
22 publications · 899 citations
17
h-index
LL
Les Levidow
The Open University, United Kingdom
17 publications · 809 citations
15
h-index
FG
Fabio Garofolo
Bristol-Myers Squibb (United States), United States
12 publications · 703 citations
12
h-index
JA
Jerry Avorn
Brigham and Women's Hospital, United States
14 publications · 921 citations
12
h-index

1–5 of 7.9K

Institutions

2.6K

1–8 of 2.6K

Venues

New England Journal of Medicine
NEJM · 65 publications · 4.5K citations
36
h-index
PubMed
Repository · 116 publications · 3.1K citations
29
h-index
Science
75 publications · 3.4K citations
28
h-index
JAMA
56 publications · 3.4K citations
28
h-index
Social Studies of Science
SSS · 25 publications · 2.3K citations
24
h-index

1–5

See also Regulatory Science
Core Methods	Physiologically Based Pharmacokinetic Modeling Real-world Evidence Model Risk Management Benefit-risk Assessment Predictive Toxicology Models Quantitative Structure-activity Relationships Risk Stratification Computational Modeling
Applications	Regulation Biomarker Discovery Adverse Drug Reaction Monitoring Predictive Toxicology Models Drug-induced Liver Injury Assessment Ames Mutagenicity Prediction Physiologically Based Pharmacokinetic Modeling System Lifecycle Management Cost-benefit Analysis Software As A Medical Device Registration Real-world Evidence
Evidence Standards	Auditing Real-world Evidence Dynamic Credibility Models
Postmarket Surveillance	Pharmacovigilance Post-market Clinical Follow-up Clinical Trial Safety Updates Spontaneous Reporting Systems Patient Registries Predictive Analytics Signal Detection Drug - Drug Interaction Detection Natural Language Processing Internet Of Things Wearable Sensors