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Extrapolation and Regression Study Written By : Dr. Dhriti Tupe, GxP Expert ® Extrapolation and Regression Study in Stability Analysis In the pharmaceutical industry, stability testing is essential for ensuring that a product maintains its quality, safety, and efficacy throughout its shelf life. Two important tools used in this process are extrapolation and regression analysis,…
Applications of Polymers in Parenteral Drug Delivery Parenteral drug delivery refers to methods of administering drugs directly into the body, bypassing the digestive system, most commonly through intravenous (IV), subcutaneous (SC), or intramuscular (IM) injections. With advancements in polymer technology, polymers have become crucial in the development of sophisticated drug delivery systems, especially for prolonged…
What is GxP Training and Why is It Important? By :Dr. Dhriti Tupe, GxP Expert ® GxP, or “Good Practice” regulations, are guidelines that ensure products in industries like pharmaceuticals, biotechnology, and food production are consistently high in quality and safe for human use. The ‘x’ in GxP stands for various fields such as Good Manufacturing…
Validation of Sterile Filtration: A Comprehensive Overview Introduction Sterile filtration is a crucial process in pharmaceutical and biopharmaceutical manufacturing. Its main objective is to remove microorganisms from products to ensure sterility without adversely affecting the product’s quality. This process is employed widely for drug products that cannot be heat-sterilized, such as biologics and other temperature-sensitive…
Digital Transformation in the Pharmaceutical Industry: How web-based applications and softwares are paving the way for AI integration By :Rohan Shah Founder & CTO ,Mighty Ventures Introduction The pharmaceutical industry has long been at the forefront of innovation, but as the complexities of drug development, clinical trials, and regulatory compliance continue to grow, the need…
Basics of LCMS (Liquid Chromatography-Mass Spectrometry) Introduction: Liquid Chromatography-Mass Spectrometry (LCMS) is a powerful analytical technique that combines the separation capabilities of Liquid Chromatography (LC) with the detection and identification strengths of Mass Spectrometry (MS). This method is widely used in various fields, such as pharmaceutical research, environmental analysis, clinical diagnostics, and food safety, to…
What Are Pharmaceutical Quality Control Laboratories and Why Are They Important? By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, Quality Control (QC) laboratories play a vital role in ensuring the safety, efficacy, and quality of pharmaceutical products. These laboratories are essential to maintaining the integrity of the drug manufacturing process, from raw materials…
Phospholipids in Depot Formulations: A Comprehensive Overview Depot formulations are an advanced pharmaceutical technique designed to release active pharmaceutical ingredients (APIs) gradually over an extended period, improving drug efficacy, reducing dosing frequency, and enhancing patient compliance. Among the various components used in these formulations, phospholipids stand out due to their biocompatibility, safety, and ability to…
What Are Stability Guidelines and Their Importance in the Pharmaceutical Industry? By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, the stability of a drug product is critical in ensuring its safety, efficacy, and quality throughout its shelf life. Stability guidelines provide a framework for evaluating how environmental factors such as temperature, humidity, and…
In Vitro–In Vivo Correlation on Parenteral Dosage Forms: A Detailed Analysis In Vitro–In Vivo Correlation (IVIVC) is a predictive mathematical model that establishes a relationship between an in vitro property of a dosage form (typically drug release or dissolution) and a relevant in vivo response (such as drug absorption or plasma concentration). IVIVC plays a…
