Designed Experiments for Pharma (2.5 day option)

In this industry-specific 2.5 day workshop, learn how to apply DOE to pharmaceutical problems. We welcome scientists, engineers, and technical professionals working in the pharmaceutical fields and API development, as well as organizations and institutions that devote the majority of their efforts to the research, development, technology transfer, or commercialization of pharmaceuticals. Throughout this course you will explore cases that come directly from this industry!

This class is only available as a private on-site workshop.

Designed Experiments for Pharma (2.5 day option)

Details

Designed Experiments for Pharma (DEPHM), 2.5 days, (2.0 CEU, In-House Only)

Customized DOE applications for the pharmaceutical industry (developed due to popular demand!)

Optimize your Product or Process

In this industry-specific workshop, learn how to apply DOE to pharmaceutical problems. We welcome scientists, engineers, and technical professionals working in the pharmaceutical fields and API development, as well as organizations and institutions that devote the majority of their efforts to the research, development, technology transfer, or commercialization of pharmaceuticals. Throughout this course you will explore cases that come directly from this industry!

During a fast-paced two and a half days explore the use of fractional factorial designs for the screening and characterization of products or processes. Also see how to achieve top performance via response surface designs, mixture designs, and multiple response optimization. Discover the role DOE plays within Quality by Design (QbD) initiatives. Practice applying all of these DOE tools while working through cases involving API's, fluidized-bed coating, tablet compression, assay optimization, synthetic mediums, HPLC, and much more.

Stat-Ease's highly experienced DOE experts will provide you with individualized guidance and support after class to help you get started on your next project—at no extra cost!

The DEPH workshop provides a broad survey of the three major types of DOE designs—factorials, response surfaces, and mixtures. After completing the course you may want to further your education by attending one of Stat-Ease's core courses (EDME, RSM, MIX).

Two optional fun and easy-to-read texts, DOE Simplified and RSM Simplified, authored by Mark Anderson and Pat Whitcomb, provide supplemental background reading for all DOE topics covered.

Simulations Provide Practice

Use Design-Expert® software to practice designing and analyzing experiments throughout the workshop. The software provides easy-to-use graphical tools to find key variables and view results. You will be given a path to all simulation and data files used in class, which are posted to a special Internet site where you can also link to a free fully-functional, but time-limited, copy of Design-Expert software for use after class.

Course Outline

 

Day 1 Section 1—Introduction to Factorial Design
 
  • Factorial design
    • The factorial design planning process
  • Basics of factorial design (tablet compression)
  • Replicated full factorial (extended drug release coating)
    • Explanation of power
 Lunch Section 2—Blocking and Fractional Factorials
 
  • Blocking
    • 28 full factorial (assay contaminants)
  • Fractional factorials
    • 28-2 case (continue assay contaminants)
    • Setup and aliases
    • Minimum run resolution V (MR5) designs
      • Case study: Wet granulation
      • Multiple response optimization
  Section 3—Introduction to Response Surface Design
 
  • Factorial with center points (bench reaction: API yield)
  • Introducing Response Surface Methods (RSM)
  • Augmenting to central composite design (CCD)
Day 2
  • “Good” response surface designs
  • Sizing for precision
  Section 4—Response Surface Methodology
 
  • Instructor led exercise (fluidized bed coating)
    • Building the design
    • Details of analysis
    • Optimization
  Section 5—Constrained Response Surface
 
  • Constrained design space
    • Optimal design (tableting process)
Lunch Quality by Design "QbD"
 
  • Illustrative example (continue tableting process)
  • QbD for an existing process (extrusion-spheronization)
  • Summary
  Section 6—Introduction to Mixture Design
 
  • What makes a mixture?
  • Mixture (Scheffé) polynomials
  • Simplex lattice designs (antiplatelet drug formulation)
  • Constrained mixture (HPLC mobile phase)
  • QbD (Transdermal Drug Delivery patch)
 Day 3 (half)
 Section 7—Combining a Mixture with a Process Factor (amount)
 
  • Mixture amount experiments (time release coating)
  • Formulation and Dosage (hormones)
  Next Steps (support)
  Section 8—Bonus Material (as time allows)
 
  • Expiry Date (drug stability characterization)

Prerequisites

Math skills, knowledge of basic statistics, and exposure to simple comparative experiments (e.g. two-sample t-test) are recommended. If you aren't ready for the Designed Experiments for Life Sciences workshop, take the online PreDOE course first (a $95 value you get for free! It takes 3-6 hours to complete. You can work at your own pace). You can assess your abilities by first taking the free self-assessment questionnaire—which is available as a pre-test within the PreDOE course—at www.statease.net.

Before attending class, please go through the One-Factor Tutorial, and then look at the One-Factor Self-Study presentation. You will find links to both below.

  1. One-Factor Tutorial
  2. One-Factor Self-Study

For more information, contact the Workshop Coordinator by e-mail or by calling 1.612.746.2038.

Additional Information

PDHs 20
Additional Information No