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Drugs and Medical Devices: Development and Regulatory Approval

Drug Development E-Books

Drug Development: Principles, Methodology and Emerging Challenges (2013) by Marco Rossi; Santina Bertone
Early Drug Development: Strategies and Routes to First-in-Human Trials (2010) by Mitchell N. Cayen (Editor)
Non-Biological Complex Drugs (2015) by Daan J.A. Crommelin; Jon S. B. de Vlieger
Global New Drug Development: An Introduction (2014) by Jan A. Rosier; Mark A. Martens; Josse R. Thomas
Intelligent Drug Development: Trials and Errors in Clinical Research (2014) by Michael Tansey
Cost-Contained Regulatory Compliance (2011) by Sandy Weinberg
Pharmaceutical and Biomedical Project Management in a Changing Global Environment (2010) by Scott D. Babler
ISBN: 0470293411
Chemical Engineering in the Pharmaceutical Industry: Drug Product Design, Development, & Modeling (2019) by M.T. am Ende & D.J. am Ende

Medical Device E-Books

Methods in Research and Development of Biomedical Devices (2013) by Kelvin, Loong, Wong, Kian
Ch.9: "Engineering and Production Management for Biomedical Devices"
Medical Device Design (2012) by Peter Ogrodnik
ISBN: 9780123919427
This book provides a bridge between engineering design and medical device development.
The Medical Device R and D Handbook, 2nd ed. (2012) by Theodore R. Kucklick
Medical Device Design and Regulation (2011) by Carl T. DeMarco
Design, Execution, and Management of Medical Device Clinical Trials (2009) by Salah Abdel-aleem
Safety Risk Management for Medical Devices (2018) by Bijan Elahi
ISBN: 9780128130995
Managing Medical Devices Within a Regulatory Framework (2016) edited by Beth Ann Fiedler
ISBN: 9780128041925