ReviewTherapeutic advances in drug safety2022
Pharmacovigilance: reporting requirements throughout a product's lifecycle.
Review in Therapeutic advances in drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- CDK4/6 inhibitor-statin interaction and rhabdomyolysis in breast cancer treatment: a case-based systematic review.Cancer chemotherapy and pharmacology · 2026Pooled it
- Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data.Headache · 2026Pooled it
- Vaccination practice and safety in children with special health care needs: A retrospective study of 1278 children.Human vaccines & immunotherapeutics · 2026Article
- Substandard and Falsified Medicines, Regulatory Capacity and Public Health: A Narrative Review With a Focus on Africa.Public health challenges · 2026Review
- Signal detection and analysis of adverse events associated with sevelamer post-marketing based on the FAERS database.Medicine · 2026Article
- Article
- Ecopharmacovigilance and pharmacovigilance: an analysis of environment-related reporting in VigiBase.Environmental science and pollution research international · 2026Article
- Exploring the Reliability of Detecting Drug-Drug Interactions that Increase the Risk of Gestational Diabetes in Adverse Event Reporting Systems.Drug safety · 2026Article
- Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.Current pharmaceutical biotechnology · 2026Review
- Hydrochlorothiazide and chlorthalidone use and glaucoma risk: pharmacovigilance analysis and nationwide cohort study.Frontiers in pharmacology · 2026Article
- Sex-specific pharmacovigilance signals and time-to-onset patterns of drug-related myoclonus and epileptic seizures: a real-world pharmacovigilance analysis.Frontiers in pharmacology · 2026Article
- Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring.Current drug safety · 2026Review
- Development and application of the vaccine reporting quality score to evaluate the vaccine adverse event reporting system.Frontiers in immunology · 2026Article
- Industry-defined opportunities for advancing big data capabilities in biopharmaceutical manufacturing.Frontiers in bioengineering and biotechnology · 2026Review
- Risk of severe infections in patients with triple-negative breast cancer treated with atezolizumab plus nab-paclitaxel: a real-world, postmarketing database study in Japan.International journal of clinical oncology · 2025Article
- Transforming Pharmacovigilance With Pharmacogenomics: Toward Personalized Risk Management.Clinical pharmacology and therapeutics · 2025Review
- Tyrosine Kinase Inhibitors and Interstitial Lung Disease: A Disproportionality Analysis Using the European Post-marketing EudraVigilance Database.Drugs - real world outcomes · 2025Article
- Adverse Reactions by Radiopharmaceuticals: Retrospective Analysis of the Portuguese National Pharmacovigilance System.The Annals of pharmacotherapy · 2025Observational
- Brodalumab: Seven-Year US Pharmacovigilance Report.Dermatology and therapy · 2025Article
- Torsade de Pointes and QT Prolongation Among Antifungal Triazoles: A Real-World, Retrospective, Observational, Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS) Database.Cardiovascular toxicology · 2025Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the safety and effectiveness of pharmaceuticals is extremely important. Pharmacovigilance is a key component of drug safety regulatory processes and is paramount for ensuring the safety profile of medications used to treat patients. All participants in the healthcare system, including healthcare providers and consumers, should understand and meaningfully engage in the pharmacovigilance process; healthcare providers should integrate pharmacovigilance into everyday practice, inviting feedback from patients. This narrative review aims to give an overview of the main topics underlying pharmacovigilance and drug safety in pharmaceutical research phase after the authorization of a drug in the United States. The US Food and Drug Administration guidance and post-approval regulatory actions are considered from an industry perspective. Plain language summary:
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.