The Quotable QbD: 10 Memorable Quips
01 September 2010
Notable quotes from people with their fingers on the pulse of QbD and the industry in general.
Featured Stories
Paul McKenzie: Bringing Order to Complexity at J&J
27 August 2010
Standards and science—and yes, QbD—are redefining the company’s pharma R&D, says global division head McKenzie.
Posted in Expert Insights, Readers' Choice0 Comments
How Do We Justify Investments in QbD?
26 August 2010
Does it make sense to convert to processes that are conducive to Quality by Design? Consultant Girish Malhotra presents financial scenarios to ponder.
Posted in Expert Insights0 Comments
What Will the FDA Say? Time to Change the Question
24 August 2010
Ask not what FDA will say about our products and processes, says Contributing Editor Ali Afnan, but rather what we can demonstrate to the Agency. Change depends on it.
Posted in Expert Insights0 Comments
QbD Classics: What Your ICH Q8 Design Space Needs
24 August 2010
In this classic article, GSK's John Peterson argues that we must use multivariate predictive distribution to understand randomness and think stochastically, and demonstrates how.
Posted in Expert Insights, Readers' Choice, Resources0 Comments
Arrogance, Ignorance, and Fear: Too Much for QbD to Overcome?
20 August 2010
We have to make it commercially painful for pharma companies not to move forward with QbD, argues Philip Morris' Gawayne Mahboubian-Jones.
Posted in Expert Insights4 Comments
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Ali Afnan
analytical methods
Bikash Chatterjee
bioprocess control
CDER
clinical trials
design of experiments
design space
development costs
drug development
drug manufacturing
Emerson Process Management
Emil Ciurczak
fda
FMEA
Girish Malhotra
green process development
GSK
helen winkle
ICH
ICH Q8
ICH Q10
IFPAC
Janet Woodcock
Lean Six Sigma
liquid chromatography
method validation
modeling
Novartis
PAT
pharmacovigilance
pharmacutical quality
process understanding
process validation
qbd
quality
Quality by Design
risk management
risk mitigation
Six Sigma
statistical analysis
time to market
Toyota
Tunnell
Validation
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