Statistical Method in Bioassay Course Outline

Course Registration

Core Concepts in Statistics and How They Combine to Make Bioassay Work

Who Should Attend: This course is intended for those who are developing, validating, managing, or maintaining biological assays that are to be used to support discovery, development, monitoring, or release of biological pharmaceutical products.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime during the 14-session live course! You will receive recordings of past sessions and invitations to join upcoming live sessions. Or sign up to receive links to recordings of any or all sessions from the previous 14-session course.

Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!

Each 90-minute session is just $362 per session or $4709 for all 14 sessions! Great group discounts are available.

Watch the recording of Session 1 anytime for free!

Click on the link below to view the free recording.
The slides for Session 1 are also available for free download:

Session 1 Recording - Free!
Download Session 1 Slides

Session 1: Introduction to Bioassay (FREE!)

Introduction to Bioassay (FREE!)

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content: 
    ● A brief history
    ● Key ideas
    ● Types of bioassays
    ● Recent big changes
    ● Current challenges

Session 2: Statistical Fundamentals (1)

Statistical Fundamentals (1)

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Inference
    ● Randomization
    ● Experimental Units
    ● Pseudoreplication
    ● Blocks
    ● Reference Distributions
    ● Assumptions

Session 3: Statistical Fundamentals (2)

Statistical Fundamentals (2)

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Transformation
    ● Outliers: Detection and management
    ● Introduction to Modeling
    ● Design basics
    − Treatment designs
    − Design structure

Session 4: Intro to Bioassay Design

Intro to Bioassay Design

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Simple designs
    ● Common practices that create complex design structures
    ● Common weaknesses in bioassay designs
    ● Properties of good bioassay designs
    ● Some examples of good bioassay designs
    ● Better bioassay designs

Session 5: Intro to Bioassay Analysis

Intro to Bioassay Analysis

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Transformation
    ● Outlier detection & management
    ● Fitting curves
    ● Simple analysis strategies for limited software
    ● The fundamental assumption
    ● Full vs. reduced models
    ● Assay & sample acceptance criteria
    ● Similarity via equivalence, why & how
    ● Estimating potency
    ● Combining results across replicate assays

Session 6: Setting Equivalence Bounds for Similarity Assessment

Setting Equivalence Bounds for Similarity Assessment

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Why equivalence tests, not difference tests
    ● Ways to measure non-similarity
    ● Challenges setting equivalence bounds
    ● Evolving strategy based on impact of non-similarity

Session 7: Mixed Models for Bioassay

Mixed Models for Bioassay

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Simple analyses showing the need to address location effects
    ● Why mixed models
    ● How mixed models address bioassay needs particularly well
    ● Interpreting the results from mixed model analyses of bioassays
    ● Challenges when fitting mixed models to bioassays

Session 8: Intro to DOE

Intro to DOE

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Why factorial experiments
    ● Intro to design & interpretation of factorials
    ● Fractional factorials
    ● Blocking factorials
    ● Response surface designs
    ● Using a sequence of experiments in bioassay development

Session 9: Development & Robustness Experiments

Development & Robustness Experiments

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Choosing factors
    ● Identifying practical units for each factor
    ● Choosing levels for each factor
    ● Putting together a design
    ● Analysis strategies
    ● Using results: next steps, SOPs, planning qualification

Session 10: Qualification & Validation Experiment Design & Analysis

Qualification & Validation Experiment Design & Analysis

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Focus on random effects
    ● Nested vs. crossed designs
    ● Smart design strategies
    ● Simple analyses
    ● Using the results

Session 11: Bioassay Stability Experiment Design & Analysis

Bioassay Stability Experiment Design & Analysis

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Simple steps to improve stability expt. Design
    ● Ideas behind analysis strategies
    ● Using stability results to check validation results
    ● Ways to monitor stability of reference standards

Session 12: Product Specifications & Process Control Limits

Product Specifications & Process Control Limits

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Customer’s vs. manufacturer’s needs
    ● From clinical experience to specs
    ● Using manufacturing & measurement experience
    ● Using stability results & release limits
    ● Process Capability
    ● Putting it all together

Session 13: Monitoring Bioassays

Monitoring Bioassays

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Designs that support better monitoring
    ● Graphical monitoring
    ● Quantitative monitoring
    ● Periodic review and revision of bioassays

Session 14: Questions, Discussion and Additional Resources

Questions, Discussion and Additional Resources

  • Instructor: David Lansky Ph.D.
  • Format: On-demand recording available now.
  • Content:
    ● Discussion
    ● An annotated bibliography

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.