PHARMACEUTICAL DRUG PRODUCT DEVELOPMENT AND PROCESS OPTIMIZATION EFFECTIVE USE OF QUALITY BY DESIGN (HB 2020) Hardcover

Pharmaceutical manufacturers frequently encounter quality issues with drug products, resulting in increasing product recalls and rejections. Achieving consistent product quality remains a significant challenge due to various influencing factors. This volume addresses this challenge by implementing the Quality by Design (QbD) approach, which aims to systematically develop drug products with predefined objectives to improve product and process understanding. The book explores the essential principles behind the efficient, effective, and cost-effective development of pharmaceutical products. It emphasizes the adoption of systematic quality principles throughout pharmaceutical development, which is crucial for continuous improvement in product quality while also reducing costs, time, and effort, and ensuring compliance with regulatory standards. The volume discusses recent advancements in developing solid oral dosage forms, modified release formulations, parenteral dosage forms, semisolid forms, transdermal delivery systems, inhalation products, ocular delivery systems, nanopharmaceuticals, and nanoparticles for oral administration.