Case Studies

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  1. DOE Reduces Bioequivalent Generic Development Time to 4 Months

    July 2016

    A generic pharmaceutical manufacturer recently hired VerGo Pharma Research Laboratories Pvt. Ltd to develop a bioequivalent with different polymorphic forms for an anti-depressant drug that had previously been patented in crystalline form only. Bioequivalence requires that a drug be pharmaceutically equivalent and that it be delivered at the same rate and same level of bioavailability so that its efficacy and safety can be expected to be the same as the original product. By using design of experiments (DOE) to reduce the number of tests required (to determine the effects of inactive ingredients on bioavailability in both fed and fasting conditions), VerGo was able to cut the development process from several years to only four months.

    A variation of this case study was also printed in R&D magazine, July 2016, as Scientists Develop Bioequivalent Drug in Months instead of Years.

    See also How Design of Experiments Can Improve Formulation Development by Jerry Fireman, March 2016, Scientific Computing magazine.

    Authors: Subrata Kundu
    Publication: Pharmaceutical Manufacturing
  2. How To Get More Learning With Less Experimentation

    January 2016
    Experimentation informs every part of the biologic lifecycle. But it is costly and time consuming — especially when you are using outdated methods. As you strive for more efficiency from your scientists and engineers, can you streamline your work processes to get more learning with less experimentation? Both multivariate analysis (MVA) and design of experiments (DoE) methods have numerous applications for simplifying the learning from large data sets and experimentation. However, many scientists and engineers still perceive these methods to be complex. Today’s newer, intuitive software applications make these techniques user-friendly for even non-statisticians. Early adopters are seeing decreased time to market, reduced development and production costs, and improved quality and reliability.
    Authors: Frank Westad
    Publication: CAMO Analytics
  3. Conquer Pilot Plant Challenges

    November 2015
    A pilot plant usually plays a key role in process development by providing essential data related to operation, safety, scale-up and other issues. The value of the pilot plant depends on the validity of the data captured. Planned experimentation is crucial to gathering meaningful data, and design of experiments (DOE) is the gold standard for finding results which are statistically significant.
    Authors: Ron Stites
    Publication: Chemical Processing
  4. Design of Experiments Validates Corn Ethanol Measurement Technology

    June 2014
    An industrial equipment supplier wanted to find the best operating conditions, as well as determine what performance its product could deliver for ethanol producers, before putting the device on the market. A DOE was run to successfully identify and validate a measurement method that has enabled the supplier to accurately evaluate the performance of the new product in a large number of plants under a wide range of operating conditions.
    Authors: Stites, Ron
    Publication: Ethanol Producer Magazine
  5. DOE It Yourself

    November 2011

    Fun science projects

    Authors: Anderson, Mark J.
    Publication: Stat-Ease, Inc.
  6. Practical Considerations for DoE Implementation in Quality By Design

    June 2010

    This article takes a look at the different things that should be considered when implementing DOE in Quality By Design.

    Authors: Shivhare, Mahesh and McCreath, Graham
    Publication: BioProcess International
  7. Case Study: R&D Test Method Expedites Speed to Market

    February 2009

    Alberto-Culver recently developed a new line of scrubs using design of experiments (DOE) that far exceeds the performance of what they thought was possible.

    Authors: Alberto Culver
    Publication: Global Cosmetic Industry
  8. Streamwise Porosity Distribution Optimization for Minimizing Wall Interference in a Transonic Wind Tunnel

    January 2009

    Modern Design of Experiments (MDOE) was used to reduce wall interference on wind tunnel measurements, increasing the quality of both the raw data and corrected coefficients.

    Authors: Owen, U. N.
    Publication: Conference
  9. Lean Six Meets Foil Stamping

    October 2008

    This article describes how a six sigma team cut setup time 40% and printing costs 5% at a Taylor Corporation unit using DOE and 33 Kluge presses.

    Originally Published in Graphic Arts Online Oct 1, 2008

    Authors: Taylor Corp.
    Publication: Graphic Arts Online
  10. Designed Experiment Optimizes Method for Removing Endocrine Disrupters

    March 2008

    Researchers successfully used DOE to evaluate potential methods for removing three common endocrine disrupters.

    Authors: Peter Jones
    Publication: Environmental Science & Engineering
  11. Design-Expert 7.1 software review

    October 2007

    Felix Grant of Scientific Computing World finds that Design Expert 7.1.3 builds on the many improvements from earlier upgrades.

    Authors: Grant, Felix
    Publication: Scientific Computing World
  12. The 10 Most Common Designed Experiment Errors

    June 2007

    This article offers 10 tips for avoiding the most common designed experiment mistakes. It is derived from Jeff Hybarger's article in the December 2006 Stat-Teaser newsletter.

    Authors: Hybarger, Jeff
    Publication: Design Product News
  13. DOE for Coatings

    August 2006

    This article is a basic introduction to design of experiments (DOE) for coatings formulations and processes. A slightly different version was published in the Coatings Technology Handbook, 3rd Edition

    Authors: Anderson, Mark & Whitcomb, Pat
    Publication:
  14. Application of Design of Experiment (DOE) Techniques to Process Validation in Medical Device Manufacture

    February 2006

    This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance.

    Authors: Dixon, D. et. al. for LOB
    Publication: Journal of Validation Technology
  15. Engineering Software Quickens Product Launch

    January 2001

    Mary Kay case study from Packaging World magazine.

    Authors: Wickham, Renee
    Publication: Packaging World

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