Debenhams

Shane Robinson

Drug Device Combination Products Paperback Book

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At a Glance
Comprehensive regulatory guidance included
Real-world medical device examples
ISO standards integration focus
294 pages of technical depth
FDA and EU compliance frameworks
Description

Book Overview DrugDevice Combination Products Design, Regulation, and PerformanceIn an era of rapidly evolving healthcare technology, DrugDevice Combination Products by Shane Robinson serves as an essential guide to one of the most complex and dynamic segments of modern medicine. This comprehensive handbook offers an indepth exploration of combination productstherapeutic innovations that integrate pharmaceutical drugs, medical devices, and biologics to create unified solutions for enhanced patient care.Through meticulously detailed chapters, the book navigates the scientific, regulatory, and engineering challenges involved in developing these products. From prefilled syringes and autoinjectors to advanced pen injector systems, readers gain insight into realworld examples of how these systems are transforming treatment delivery for chronic conditions such as diabetes, asthma, and cardiovascular disease.The text delves into regulatory frameworks including FDAs 21 CFR Part 4 and the EU Medical Device Regulation (MDR 2017/745), guiding readers through compliance with quality systems, design controls, and risk management. The integration of ISO standards such as ISO 13485 and ISO 14971 further reinforces the books focus on global harmonization.Robinson expertly outlines critical topics such as usability engineering, biocompatibility testing, performance validation, and lifecycle management. With technical depth and regulatory clarity, the book bridges pharmaceutical sciences,...

SKU: M9798315875949
Product Details & Care

Binding: Paperback;294 pages; Publisher: Amazon Digital Services LLC - KDP; Classification: N/A; Weight: 517.35 g; Dimensions: N/A

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