Designed Experiments for Pharma (2-day), $1295

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!


Price includes a $95 fee for workshop materials which is subject to state and local taxes.


A 10% discounted Early Bird rate applies to registrations made 6 weeks prior to the workshop date.

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Price: $95.00

deph

Details

Designed Experiments for Pharma (DEPH) (2 days)

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 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. 

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
  Section 2—Blocking and Fractional Factorials
 
  • Blocking
    • 28 full factorial (assay contaminants)
  • Fractional factorials
    • 28-2 case (continue assay contaminants)
    • Setup and aliases
  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)
 
  • “Good” response surface designs
  • Sizing for precision
 Day 2 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)
  • Quality by Design "QbD"
    • Illustrative example (continue tableting process)
    • 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)
  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)

 Section 7—Combining a Mixture with a Process Factor (amount)
 
  • Mixture amount experiments (time release coating)
  • Formulation and Dosage (hormones)

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 Experiment Design Made Easy workshop, take the online PreDOE course first (a $95 value you get for free! It takes 2-3 hours to complete. You can work at your own pace). Access the PreDOE here.

Before attending class, please download a trial of Design-Expert software, v10 (if you do not already have access to it) and work through the General Multilevel-Categoric One-Factor tutorial.

Additional Information

PDHs 16 (equals 1.6 CEUs)
Additional Information

Workshop location details will be provided with your confirmation letter, which you will receive once the minimum enrollment requirements are met.

Here are addresses we have used in the past:

Minneapolis, MN (Stat-Ease headquarters): 2021 East Hennepin Ave, Suite 480, Minneapolis, MN 55413

Edison, NJ: Raritan Plaza III, 105 Fieldcrest Avenue, Suite 201, Edison, New Jersey 08837, Website

San Diego, CA: 350 10th Avenue, Suite 950, San Diego, California 92101, Website 

San Jose, CA: 2025 Gateway Place, Suite 390, San Jose, California 95110, Website 

Recommended Texts and Software

Recommended Texts and Software

Purchase the recommended text or software at the time of registration to receive a 20% discount.