09 December 2010
Better understanding of stability testing, statistically relevant sampling, Linear Least Squares' and Excel's limitations, knowledge transfer and common sense are some of the things on one QbD/PAT Advocate's wishlist for the industry, and its quality assurance and control teams, this year
Posted in Expert Insights0 Comments
09 December 2010
In two new surveys, Price Waterhouse Cooper analysts examine industry's and the public's views of FDA. Although they note improvement in communications, industry says messages can be inconsistent. Industry respondents doubt the Agency has the resources to oversee the Critical Path Initiative. User fees, resources, and transparency surfaced as issues in both surveys.
Posted in QbD News0 Comments
08 December 2010
GSK’s CEO recently wrote an interesting editorial in The Economist on the drug industry’s challenges. He criticizes the “Big R&D” approach, which, as he notes, didn’t work. But there was no mention anywhere of Quality by Design in his essay, and his views seem to betray pharma’s mistrust of (or lack of interest in) techniques and approaches that have been proven in other industries, and a lack of understanding of when industrial engineering principles work, and when they don’t, in connection with pharma R&D.
07 December 2010
A team from BMS Process Research and Development explores the advantages of mechanistic modeling for controlling the risk of an API impurity.
Posted in Expert Insights, Resources0 Comments
06 December 2010
A look at a new software offering from Nirvention of the Netherlands.
Posted in QbD News0 Comments
01 December 2010
Applying analytics throughout the organization, rather than in pockets of activity as pharma typically has, can be a catalyst for improved business performance. Pharmatech's Bikash Chatterjee explains.
Posted in Expert Insights0 Comments
Added on 13 December 2010
muscopatt: I certainly hope no one paid to hear burrill on th...
zasmine: It is a very state indeed when the regulator doesn...
Ali Afnan: Many thanks for your comment. I agree with you in...
aajax: Has anyone done a good analysis of the cost to the...
aajax: Sorry, but the only thing that will change the sit...
