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Chemical Engineering in the Pharmaceutical Industry

Drug Product Design, Development, and Modeling

by Mary T. am Ende Editor · David J. am Ende Editor


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A guide to the important chemical engineering concepts for the development of new drugs, revised second edition

The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling.

The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition:

  • Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions
  • Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up
  • Offers analytical methods and applied statistics that highlight drug product quality attributes as design features
  • Presents updated and new example calculations and associated solutions
  • Includes contributions from leading experts in the field
  • Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

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    Mary T. am Ende (Editor)

    Mary T. am Ende Ph.D is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years’ experience in drug product formulation, process develop...

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    Chemical Engineering in the Pharmaceutical Industry
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