Dosage Form Design Parameters, Volume 2 (Advances in Pharmaceutical Product Development and Research)

Oversized hardcover, shipping weight over 2kg, xix + 794 pages, NOT ex-library. Printed in the UK. Book is clean and bright with the appearance of little wear; unmarked text, free of inscriptions and stamps, firmly bound. A short crease in the upper outer corner of a portion of leaves. Boards show short corner creases, a long horizontal wrinkle in the protective laminate on the front panel. Issued without a dust jacket. -- An end-to-end guide to dosage form design - from solid-state properties and processability to IVIVC, high-throughput PK, and ADMET - with practical coverage of statistics (ANOVA), sterilization, packaging, documentation, IP, and ethics for translating lab discovery into market-ready products. -- This book provides a complete roadmap from drug substance to market-ready dosage form. It starts with solid-state fundamentals - polymorphism, crystallization, and strategic use of the amorphous state - and links particulate and bulk properties to processability and product performance. A distinctive, hands-on statistics core equips readers to design robust experiments and defend results, covering hypothesis testing, experimental design (DoE/ANOVA), and sound sampling. The formulation-biology interface follows: drug-excipient compatibility, in vitro-in vivo correlation (IVIVC), and modern high-throughput pharmacokinetic analysis. The final modules address the operational and regulatory ecosystem - sterilization, packaging material selection, regulatory documentation, food and drug law, intellectual property, and research ethics - plus advanced tools such as computer-aided ADMET prediction and guidance on software use and licensing. Integrating theory, data, and practice, the volume helps scientists turn laboratory discovery into reliable products and regulatory success. Ideal for researchers, advanced students, and industry professionals in pharmaceutical sciences and product development. -- In an era where drug development faces unprecedented challenges - ranging from escalating R&D costs and regulatory hurdles to the demand for personalized medicines - mastering dosage form design is more crucial than ever. This volume stands out for its holistic approach, combining the foundational sciences (material properties, statistical rigor) with cutting-edge applications (high-throughput screening, computer-aided predictions) and indispensable industry insights (regulatory compliance, intellectual property). It's an invaluable resource for innovating within the pharmaceutical sciences, for anyone invested in the future of drug development.…