Challenges and Complications of Poly(lactic coglycolic acid)Based Long Acting Drug Product Development Poly(lactic coglycolic acid) (PLGA) is a biodegradable copolymer approved by the FDA and EMA for use in drug delivery systems, particularly for long acting injectables (LAI) and implantable drug products. Due to its customizable degradation rates and biocompatibility, PLGA has been extensively used…

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…

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…