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This book is a structured approach to designing a product and its associated manufacturing process. It guides pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by the three researchers renowned in this field, this invaluable resource is an essential tool for all pharameutical professionals.