Tag Archive | "design space"

Transdermal Drug Development Using Quality-by-Design

By Bir (Barry) Gujral and Peter Amanatides, Noven Pharmaceuticals

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Framing a QbD Design Space with Tolerance Intervals

By Mark J. Anderson, Principal, Stat-Ease, Inc.

Given the push for Quality by Design by FDA and agencies worldwide, statistical methods are becoming increasingly vital for pharmaceutical manufacturers. Design of Experiments (DOE) is a primary tool because “it provides a structured, organized method for determining the relationship between factors affecting a process and the response of that process” [1].

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Staying Within the Lines? Interpolation vs. Extrapolation in the Design Space

By Agnes Shanley

A presentation at IFPAC last Thursday brought on some heated debate about the Design Space, and  just how dynamic it can, or should, be.  Should any changes due to unanticipated “real world” situations necessarily trigger the development of a new design space, and post-approval change filings and more testing?

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QbD Classics: Comparing Mechanistic and Empirical Models at BMS

In what might be called an “instant classic,” a team of authors from Bristol-Myers Squibb Process Research and Development has published, in the Journal of Pharmaceutical Innovation, a comprehensive study on Utilizing Mechanistic and Empirical Modeling in Quality by Design. “In this case study, we present an approach for employing modeling to help define the design space for a reaction with potential to generate an impurity that could impact the quality of an API,” the abstract explains. The approach consists of evaluating reaction parameters and developing assumptions, developing the mechanistic model to predict the impurity, creating and veriftying a design space.ide parameters ranges for manufacturing flexibility. The BMS team offers ample illustrations of the work done throughout these various stages.

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Materials from ICH Washington Training Workshops

Earlier this month, ISPE and PDA cosponsored three days of workshops with the ICH Quality Implementation Working Group (Q-IWG) related to improving participants’ understanding of ICH Q8, Q9, and Q10 guidelines and their implementation. For those unable to attend, the training materials are now available in full, in pdf form, on ISPE’s web site.

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Contemplating the Design Space

Drug development experts continue to wrestle with the concept of the Design Space. Someone with a knack for explaining complex concepts such as Design Space in plain terms is Bikash Chatterjee, CTO of Pharmatech Associates. As such, we’ve pulled the videos below, in which Bikash tackles questions related to Design Space, out of our vaults.

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