Extractables and leachables: definitions, differences & facts Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they…
Visible Particles in Parenteral Drug Products: A Review of Current Safety Assessment Practice Visible particles (VPs) in parenteral drug products…
Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments. They provide a rigorous framework…
Why DQ, IQ, OQ, PQ Are Mandatory in Quality Assurance: Why It’s Essential and How to Handle It? By :Dr.…
Cleaning Validation and Verification Reporting: A Mandatory QA Requirement By :Dr. Dhriti Tupe, GxP Expert ® Introduction In pharmaceutical manufacturing, ensuring…
Handling Elemental Impurities Risk Assessments in Pharmaceuticals By :Dr. Dhriti Tupe, GxP Expert ® A Comprehensive Guide Elemental impurities in…
Leading Hidradenitis Suppurativa Treatments in the Market Currently, some of the top medications for treating hidradenitis suppurativa (HS) include BIMZELX…
Some basics of Pharmacokinetics (PK) analysis: Pharmacokinetics refers to the study of how a drug is absorbed, distributed, metabolized, and eliminated…
Bristol Myers Squibb Advances Opdualag to Phase 3 Trials for Non-Small Cell Lung Cancer Bristol Myers Squibb (BMS) is set…
Keytruda's Triumph in Early-Stage Triple-Negative Breast Cancer: A New Standard of Care Merck's Keytruda (pembrolizumab) has achieved a significant milestone…