Regulatory Pharmacy

Regulatory Pharmacy is a field of pharmacy that ensures pharmaceutical products comply with national and international regulatory standards for safety, efficacy, and quality throughout the entire product lifecycle from development to post-market surveillance.

672

Publications

26.1K

Citations

Authors

809

Institutions

Publications per year

2017–2026

165

Parents

Pharmacy

Children

Bioequivalence RegulationClinical Trial RegulationControlled Substances RegulationDrug Approval ProcessesGood Clinical PracticeGood Laboratory PracticeGood Manufacturing PracticeLabeling RegulationPharmaceutical CompliancePharmaceutical Inspection

Publications

672

GlobCover - Products Description and Validation Report

P. Bicheron, Defourny Pierre, Carsten Brockmann et al. · Joint Research Centre (European Commission) · 2008 · 649 citations

Pharmacy, Regulatory Pharmacy, Method Validation +10

Labeling Accuracy of Cannabidiol Extracts Sold Online

Marcel O. Bonn‐Miller, Mallory Loflin, Brian F. Thomas et al. · JAMA · 2017 · 530 citations · Full text

Pharmacy, Pharmaceutical Analysis, Regulatory Pharmacy +11

American National Standard for the Safe Use of Lasers.

Annals of Internal Medicine · 1975 · 506 citations

Health Professions, Regulatory Pharmacy, Patient Safety +13

MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

Michael Mendicino, Alexander M. Bailey, Keith Wonnacott et al. · Cell stem cell · 2014 · 490 citations · Full text

Pharmacy, Regulatory Pharmacy, Clinical Trial Regulation +9

Online pharmacies: desirable characteristics and regulations

Harshily Kumaran, Chiau Soon Long, Faizah Safina Bakrin et al. · Drugs & Therapy Perspectives · 2020 · 377 citations

Pharmacy, Pharmacy Practice, Regulatory Pharmacy +14

1–5 of 672

Authors

SW
Stuart Walker
Centre for Innovation in Regulatory Science, United Kingdom
5 publications · 95 citations
5
h-index
MG
Matthew Grissinger
Institute for Safe Medication Practices, United States
4 publications · 84 citations
4
h-index
CA
Cheryl A. Thompson
University of Illinois Urbana-Champaign, United States
4 publications · 85 citations
4
h-index
RW
Roger Williams
King's College Hospital, United Kingdom
4 publications · 152 citations
4
h-index
RB
Roger Bate
American Enterprise Institute, United States
4 publications · 86 citations
4
h-index

1–5 of 2K

Institutions

809

1–8 of 809

Venues

PubMed
Repository · 50 publications · 1.5K citations
21
h-index
American Journal of Health-System Pharmacy
AJHP · 32 publications · 1.2K citations
18
h-index
Drug Safety
15 publications · 779 citations
15
h-index
JAMA
11 publications · 1.5K citations
11
h-index
Regulatory Toxicology and Pharmacology
RTP · 11 publications · 310 citations
11
h-index

1–5

See also Regulatory Pharmacy
Core Methods	Physiologically Based Pharmacokinetic Modeling Risk Management System Lifecycle Management Cost-benefit Analysis In Decisions Post-marketing Surveillance Compliance Auditing Predictive Toxicology Models Degradation Product Profiling Investigational Device Exemptions
Compliance Standards	In Vitro Diagnostic Regulation Quality Management Systems Data Protection Controlled Substances Regulation
Lifecycle Oversight	Pharmacovigilance Regulatory Sandboxes Real-world Evidence Risk Management System Lifecycle Management Post-market Surveillance
Regulatory Documents	Ectd Submission Format Clinical Trials Marketing Authorization Applications
Stakeholders	Regulatory Pharmacy Standards Organizations