Jaano & Seekho – Know More. Think Deeper. Stay Ahead.
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Extractables and leachables: definitions, differences & facts Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. The FDA defines the two terms as follows: Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent Leachables…
Visible Particles in Parenteral Drug Products: A Review of Current Safety Assessment Practice Visible particles (VPs) in parenteral drug products (PDPs) pose significant safety risks to patients and are a critical quality concern in the pharmaceutical industry. Despite technological advancements in particle detection and stringent regulatory controls, contamination with VPs remains a challenge. This review…
Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments. They provide a rigorous framework for testing hypotheses and drawing reliable conclusions. However, statistics plays a crucial role in ensuring that clinical trial results are accurate, unbiased, and meaningful. In this blog post, we will explore the significance of statistics…
Why DQ, IQ, OQ, PQ Are Mandatory in Quality Assurance: Why It’s Essential and How to Handle It? By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical and life sciences industries, ensuring that equipment, systems, and processes are properly designed, installed, and operated is not just best practice—it’s a regulatory requirement. The key tools used…
Cleaning Validation and Verification Reporting: A Mandatory QA Requirement By :Dr. Dhriti Tupe, GxP Expert ® Introduction In pharmaceutical manufacturing, ensuring the quality and safety of products is paramount. One critical aspect of quality assurance (QA) is cleaning validation and verification, which confirms the effectiveness of cleaning processes in removing residues and contaminants. Why is Cleaning…
Handling Elemental Impurities Risk Assessments in Pharmaceuticals By :Dr. Dhriti Tupe, GxP Expert ® A Comprehensive Guide Elemental impurities in pharmaceuticals can be harmful to patients. Regulatory agencies have set guidelines to manage these risks through proper assessments. In this blog, we’ll explore the essentials of elemental impurities risk assessments, including key considerations, best practices,…
Leading Hidradenitis Suppurativa Treatments in the Market Currently, some of the top medications for treating hidradenitis suppurativa (HS) include BIMZELX (bimekizumab) by UCB Biopharma, COSENTYX (secukinumab) by Novartis, and HUMIRA (adalimumab) by AbbVie/Eisai. Until 2023, HUMIRA dominated the market, even though its US patent expired in December 2016. AbbVie’s strong patent defense in the US…
Some basics of Pharmacokinetics (PK) analysis: Pharmacokinetics refers to the study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. The pharmacokinetic analysis set is created to analyze PK data collected from study participants. This set typically includes patients who have received the drug of interest and have available PK data, such…
Bristol Myers Squibb Advances Opdualag to Phase 3 Trials for Non-Small Cell Lung Cancer Bristol Myers Squibb (BMS) is set to push its PD-1/LAG-3 combination therapy, Opdualag, into phase 3 trials for first-line non-small cell lung cancer (NSCLC), two years after its initial FDA approval in melanoma. The registrational trial, named RELATIVITY1093, will evaluate Opdualag,…
Keytruda’s Triumph in Early-Stage Triple-Negative Breast Cancer: A New Standard of Care Merck’s Keytruda (pembrolizumab) has achieved a significant milestone in the fight against early-stage triple-negative breast cancer (TNBC), with new data demonstrating a substantial improvement in overall survival rates. This development follows an earlier controversy over its approval based on preliminary endpoints. At the…
