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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students. From the Back Cover Tested-and-proven strategies for developing and manufacturing low-dose oral drug products Developing and commercializing a low-dose oral drug product presents a number of hurdles that can quickly offset the drug's benefits. Written by a team of leading scientists in drug development, this book collects and synthesizes the knowledge, techniques, and strategies needed for developing low-dose drugs successfully. With this book's practical support, readers can overcome the hurdles at all stages in drug development, from formulation to manufacturing and control to regulatory compliance. Following an overview of the drug discovery and development process, the book is divided into four parts: Part One examines formulation and process development of low-dose drugs, including theoretical considerations concerning the particle size of the drug substance and content uniformity, micronization of the drug substance, and manufacturing platform technologies. Part Two focuses on challenges in analytical method development, including analytical control strategy, physical characterization of the micronized powder and the solid state of the active pharmaceutical ingredient in dosage forms, and cleaning verification of manufacturing equipment. Part Three investigates containment technologies used in analytical laboratories and manufacturing plants. Part Four deals with important regulatory considerations. Readers learn how a variety of analytical methodologies are used in low-dose drug development, including dissolution testing, NMR, HPLC, and X-ray diffraction. Moreover, the book explains several possible manufacturing techniques, such as wet granulation, roller compaction, and direct compression alongside containment technologies for highly potent drugs. Case studies throughout the book demonstrate how particular strategies and techniques are applied in practice. Pharmaceutical scientists as well as students will find overcoming the obstacles in developing low-dose drug products much easier when they have this book on hand to consult at all stages in the drug development and manufacturing process.





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