Pharma Digest
Common QC Lab Errors in Pharma
Q: What are the major root causes of QC lab errors? Q: What is a common error in HPLC sample preparation? A: Improper sample dissolution leading to inaccurate quantification, peak area variability, and inconsistent retention times. Q: What are the root causes of this issue and How it resolved? A: ... Read More
Sink Factor in Dissolution Testing
Dissolution testing is a cornerstone of pharmaceutical development, providing invaluable insights into how drugs behave in the body. One critical aspect often overlooked is the sink factor and its pivotal role in ensuring the accuracy and relevance of dissolution results. What is Sink Factor? Sink factor refers to the ratio ... Read More
Biodegradable Polymers in Drug Delivery
Exploring the eco-friendly side of pharmaceuticals with biodegradable polymers like Polylactic Acid (PLA). Learn how these sustainable materials are making waves in drug delivery, providing therapeutic benefits while minimizing environmental impact. Advantages of PLA in Drug Delivery Real-time Examples of PLA in Drug Delivery Read also: Resource Person: Pradip Kokane
Biotechnology in Drug Discovery
In the dynamic landscape of pharmaceuticals, biotechnology has emerged as a powerful tool. From genetic engineering to the manipulation of biological systems, biotech methods are instrumental in identifying novel drug targets and designing innovative therapies. Genomic Medicine Unraveling the mysteries encoded in our genes, genomic medicine is revolutionizing how we ... Read More
Nanotechnology in Drug Formulation
Today, let’s embark on a journey into the fascinating realm of nanotechnology in drug formulation. Discover how nanoparticles are reshaping the pharmaceutical landscape, driving innovation, and transforming patient care. The Role of Nanotechnology Precision Delivery Abraxane (Paclitaxel Albumin-bound Nanoparticles)Nanoparticles enable targeted delivery of therapeutics to specific cells or tissues, enhancing ... Read More
Solid Dispersions in Pharmaceutical Formulations
Solid dispersions stand as a cornerstone of modern pharmaceutical formulation, offering innovative solutions to enhance drug solubility, bioavailability, and therapeutic efficacy. Understanding Solid Dispersions: Solid dispersions involve dispersing one or more active pharmaceutical ingredients (APIs) within a solid matrix, typically a polymer or carrier material. This approach addresses challenges associated ... Read More
The Science Behind Effervescent Tablets
Ever marveled at the rapid fizz of an effervescent tablet? Behind that effervescence lies a meticulously crafted blend of excipients, each serving a crucial role in the tablet’s formulation. Acidulants: Think citric acid or tartaric acid. These key players react with bicarbonates, like sodium bicarbonate or potassium bicarbonate, triggering the ... Read More
Drug-Device Combination Products | Innovations and Compliance
In the ever-evolving landscape of medical technologies, drug-device combination products represent a cutting-edge integration of drugs, medical devices, and biologics. These products offer innovative solutions for disease management, but they also demand a robust understanding of regulatory frameworks and compliance to ensure safety, efficacy, and quality. What Are Combination Products? ... Read More
QMS in Pharmaceutical Industry
A Quality Management System (QMS) is a formalized framework that outlines the structure, responsibilities, and processes for achieving quality objectives in an organization. The QMS ensures that products or services meet customer and regulatory requirements. Content of a QMS: A typical QMS consists of the following elements: Quality Policy: A ... Read More
Navigating Bioequivalence Study Guidelines Across Global Regulatory Bodies
When conducting bioequivalence (BE) or bioavailability (BA) studies for regulatory approval, guidelines from different regulatory bodies must be adhered to. Here’s a summary of the key considerations and variations across major regulatory agencies Regulatory Guidelines Comparison USFDA Special Cases: Study Design: EMA Acceptance Range: Study Design: WHO Study Design: MHRA ... Read More
Comprehensive List of Pharmaceutical Guidelines
Self Inspection & Batch Review Risk Management Deviation Handling Change Control Out of Specification (OOS) Corrective and Preventive Action (CAPA) Process Validation Cleaning Validation Data Integrity Stability Studies GMP Pharmaceutical Quality System Pharmaceutical Development Good Storage and Distribution Practices (GSDP) Electronic documents and records Read also: