Drug Safety
Explore all topics, guides, and frameworks related to Drug Safety.
Articles in this section
13- Drug-Induced QT Prolongation: Cardiac Safety Assessment in Clinical Development and Pharmacovigilance Explains how QT/QTc findings are interpreted, why QTc is a biomarker rather than a direct measure of torsade risk, and how clinical and nonclinical evidence are integrated when assessing potential drug-induced proarrhythmia. Read Article →
- Drug-Induced Pulmonary Toxicity: Respiratory Safety Assessment in Clinical Development and Pharmacovigilance Explains how drug-induced pulmonary toxicity is recognised by phenotype, how imaging and functional evidence are interpreted with competing causes, and how individual cases are integrated into clinical-development and post-marketing safety conclusions. Read Article →
- Drug-Induced Kidney Injury: Renal Safety Assessment in Clinical Development and Pharmacovigilance Explains how potential drug-induced kidney injury is recognised and characterised, why changes in kidney function are not synonymous with structural injury, and how renal evidence is integrated across clinical development and post-marketing safety assessment. Read Article →
- Drug-Induced Cardiac Toxicity: Cardiovascular Safety Assessment in Clinical Development and Pharmacovigilance Explains how cardiovascular toxicity is characterised by phenotype and mechanism, how ECG, biomarkers, imaging and clinical outcomes are interpreted together, and how cardiac safety signals are assessed across development and post-marketing pharmacovigilance. Read Article →
- Drug-Induced Hematologic Toxicity: Hematologic Safety Assessment in Clinical Development and Pharmacovigilance Explains how hematologic abnormalities are characterised by lineage, severity, mechanism and clinical consequence, how competing causes are assessed, and how individual findings are integrated into clinical-development and post-marketing safety conclusions. Read Article →
- Hy's Law: Identifying Potential Serious Drug-Induced Liver Injury Explains why Hy's Law is a drug-safety signal concept rather than a diagnostic test, how potential cases are identified and adjudicated, and how individual biochemical findings contribute to assessment of a medicine's potential for severe DILI. Read Article →
- eDISH: Evaluating Drug-Induced Serious Hepatotoxicity in Clinical Trials Explains how eDISH organises aminotransferase and bilirubin data to identify potentially important liver-safety patterns, how the major plot regions should be interpreted, and why eDISH supports rather than replaces individual medical assessment of suspected DILI. Read Article →
- Drug-Induced Neurotoxicity: Neurological Safety Assessment in Clinical Development and Pharmacovigilance Explains why neurological toxicity requires phenotype-driven assessment, how nonclinical safety pharmacology and clinical evidence are integrated, and how seizures, encephalopathy, neuropathy, movement disorders and inflammatory syndromes are evaluated without relying on a single diagnostic rule. Read Article →
- Teratogenicity in Pharmacovigilance Explains how medicinal products can affect embryo-fetal development, how teratogenicity differs from broader reproductive toxicity, how human and non-clinical evidence are integrated, and how pregnancy exposure is managed through pharmacovigilance and risk minimisation. Read Article →
- Bispecific and Multispecific Antibodies: Biology, Clinical Development and Pharmacovigilance Bispecific and multispecific antibodies cannot be interpreted as a single safety class. This article connects molecular architecture and target-pair biology with pharmacology, clinical development, adverse-event patterns, risk minimisation and product-specific pharmacovigilance. Read Article →
- Drug-Induced Liver Injury (DILI): From Liver Test Abnormalities to Causality and Regulatory Safety Assessment Understand how drug-induced liver injury is recognised and characterised, how biochemical patterns and clinical context inform causality assessment, and how DILI evidence is translated into pharmacovigilance and regulatory safety decisions. Read Article →
- Drug–Drug Interactions and Pharmacovigilance: Recognising, Assessing and Characterising Safety Risks Drug–drug interactions can alter exposure, pharmacological effects or both. In pharmacovigilance, the challenge is to distinguish a clinically meaningful interaction from coincidental concomitant use and to determine how the interaction contributes to the observed adverse reaction. Read Article →
- Posterior Reversible Encephalopathy Syndrome (PRES) Associated With Medicinal Products Understand posterior reversible encephalopathy syndrome, its clinical and radiological features, the mechanisms through which medicinal products may contribute to PRES, and the importance of distinguishing drug association from causation. Read Article →