Thoughts on Applying ICH Q8 to Analytical Methods
QbD has been applied to manufacturing processes, but can it be applied to analytical methods? Mourne Training Services' Oona McPolin considers the topic.
View ArticleA QbD-based Methodology for the Rapid Development of LC Methods
Using ICH Q8 principles for Design of Experiments, S-Matrix Corp. has developed a means of defining a design space for optimizing the performance and robustness of liquid chromatography operations.
View ArticleDeciphering ICH Q8
This article is part of a series by Emil Ciurczak highlighting the need to update current ICH guidances in light of the PAT and QbD initiatives now influencing the industry. Other articles in the...
View ArticleVideo: What Do Pharmaceutical Manufacturers Really Need to Know about ICH Q8R?
Insights from our QbD Chat video series, with Bikash Chatterjee of Pharmatech Associates.
View ArticleQ8, Q9, Q10: Questions to Contemplate
FDA has released a "Q8, Q9, and Q10: Questions and Answers" Guidance Document, with straightforward answers to some key FAQs about Quality by Design.
View ArticleExploring Three-Letter Acronyms in Bethesda
Change may not have been in the air at FDA's "Partnering with Industry" Conference in Bethesda this week, but process analytical technologies (PAT) was once again in the spotlight, as the critical ally...
View ArticleImplementing Quality by Design: Are You Ready, or Not?
The question is not whether Quality by Design is ready to help you solve the perennial challenges of drug development and manufacturing, but whether you are ready for it. Tunnell's Bill Schmidt...
View ArticleQbD Classics: What Your ICH Q8 Design Space Needs
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.
View ArticleNasr in Chicago: An ICH Working Group Progress Report
FDA's Moheb Nasr remains positive about the adoption of ICH Q8, Q9 and Q10, and says that the industry-regulatory relationship is healthier than ever.
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