Overview

Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology a leading platform to deliver poorly water soluble drugs, a major hurdle in today s pharmaceutical industry. Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world

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9781118901380

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Ann Newman is a pharmaceutical consultant with Seventh Street Development Group, where she provides consulting, training, and webcast services on solid-state pharmaceutics and pharmaceutical development. She is also an Adjunct Professor and Lecturer in the Department of Industrial and Physical Pharmacy at Purdue University. A senior pharmaceutical scientist with demonstrated scientific and leadership expertise in the pharmaceutical industry, Dr. Newman has over 25 years of large pharma and contract research experience.

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