MISSION
The concept of Pharmaceutical Quality by Design, as articulated by FDA in 2008, advances a smarter approach to drug development, one that examines risks over the entire life cycle of any drug and encompasses, not only finished drugs, but APIs, excipients, drug delivery forms, analytical methods and packaging.
This Web site will focus exclusively on the key concepts of Quality by Design as they apply to both biopharmaceuticals and small molecule drug development, focusing on the definition of critical quality attributes, critical process parameters and the design space, the use of process analytical technologies (PAT) and risk assessment.
The end goal is improving technology transfer, eliminating patient safety and environmental risks, quality problems, expensive and redundant testing and documentation, and product failure.
Writing for this website are a number of expert practitioners within the pharmaceutical industry, as well as global regulators, independent consultants, academics and technology providers. They will share best practices that are being applied today, and also visions of how drug development will work in the future, as QbD methodologies, new technologies and approaches are used to advance a smarter and less wasteful approach to drug development.
Our Editorial Advisors:
Ali Afnan
John Avellanet
Prabir Basu
James Blackwell
Bikash Chatterjee
Jim Cheney
Emil Ciurczak
Alistair Gillanders
Ajaz Hussain
Jason Kamm
Girish Malhotra
Russ Somma
Alicia Tebar Perez
Sam Venugopal
Contact Us
Tonia Becker
Publisher
Phone: 630-467-1300 ext. 455
tbecker@putman.net
Agnes Shanley
Editor-in-Chief
Phone: 630-467-1300 ext. 410
ashanley@putman.net
Paul Thomas
Senior Editor
Phone: 630-467-1300 ext. 326
pthomas@putman.net
Michele Vaccarello Wagner
Senior Editor, Digital Media
Phone: 630-467-1300 ext. 463
mvaccarello@putman.net
Sales Contacts:
Jeanne Freedland
Digital Sales Specialist
Phone: 630-467-1300 x325
jfreedland@putman.net
Matt O’Shea
Associate Publisher
Phone: 630-467-1300 x373
moshea@putman.net
Polly Dickson
Account Manager
Phone: 630-467-1300 x396
pdickson@putman.net