The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

Arzu Selen,Paul A. Dickinson,Anette Müllertz,John R. Crison,Hitesh Mistry,Maria T. Cruanes,Marilyn N. Martinez,Hans Lennernäs,Tim Wigal,David C. Swinney,James E. Polli,Abu T.M. Serajuddin,Jack A. Cook,Jennifer B. Dressman

The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

2014

Arzu Selen
Paul A. Dickinson
Anette Müllertz
John R. Crison
Hitesh Mistry
Maria T. Cruanes
Marilyn N. Martinez
Hans Lennernäs
Tim Wigal
David C. Swinney
James E. Polli
Abu T.M. Serajuddin
Jack A. Cook
Jennifer B. Dressman

The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development and performance by using therapy-driven target drug delivery profiles as a framework to achieve the desired ...

Keywords:

Biopharmaceutics
Drug
Risk analysis (engineering)
New product development
Target drug
Risk assessment
Pharmacology
Chromatography
Medicine
controlled delivery
drug product

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