Tag Archive | "design of experiments"

What to Look for in Statistical Software

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

Statistical methods are becoming increasingly important for the pharmaceutical industry. The FDA and other regulatory and standard-setting organizations are moving swiftly to establish Quality by Design (QbD) guidance relevant to the needs of pharmaceutical manufacturing. The FDA suggests the use of design of experiments (DoE) because “it provides a structured, organized method for determining the relationship between factors affecting a process and the response of that process.”

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Using Design of Experiments to Optimize Chiral Separation

By Robert Tinder, Principal Scientist, Roche Pharmaceuticals

Editor’s Note: The author joined Roche in July 2010; the work discussed in this article took place previously at Wyeth Pharmaceuticals.

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From Israel, Rugged and Robust QbD

Earlier this month, Jerusalem played host to the 2nd Annual QbD Conference in Israel. The program, titled “Rugged and Robust Product Development in the Pharmaceutical Industry,” was organized by varied sponsors, from The Hebrew University of Jerusalem and University of Wisconsin to manufacturers like Teva and Perrigo.

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Applying QbD to Chromatography: Know Thy Model

By Scott Rudge, PhD, COO, RMC Pharmaceutical Solutions

Note: The following was originally published on the RMC Pharmaceutical Solutions blog and is reprinted with the author’s permission.

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A 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. Richard Verseput and Graham Shelver share the detailed slides that they have presented recently in educational sessions with the FDA. To access the presentation, click here.

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Optimizing Design of Experiments for Fluid Bed Coating

Upsher-Smith Laboratories (Minneapolis, Minn.) faced a problem with a fluid bed coating process that produced inconsistent results. Many of the coating parameters interacted with each other, so conventional one-factor-at-a-time (OFAT) experiments were unable to resolve the issue. Sarah Betterman, scientist for Upsher-Smith, used design of experiments (DoE) to determine how the key coating process parameters affect dissolution, the critical response.

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