Introduction to Statistics for Potency Bioassays Course Outline

Register Now

Who Should Attend: This course is designed for scientists, managers, and regulatory affairs professionals who work with bioassays and need to better understand the underlying statistics. The course serves equally well as an introductory or refresher course in biostatistics and includes topics and examples specific to potency bioassays.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime during the 12-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 12-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 60-minute session is just $339 per session or $3732 for all twelve sessions! Great group discounts are available.

FREE WEBINAR! The on-demand recording of Session 1: StatSpeak: Statistical Terms & Why They Are Important is available for FREE! Click HERE to watch Session 1 anytime.

Session 1: Statspeak

Statspeak – Statistical Terms & Why They Are Important (FREE!)

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: This session will define the key statistical terms of population, random sample, independence, replicate, distribution and others.  Examples relevant to bioassays will be used to illustrate these terms and why they are important.  These concepts provide a framework for understanding and applying statistics to real world problems.

Session 2: Descriptive Statistics

Overview of Basic Descriptive Stats and the Relationships Among Them

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: Descriptive statistics are used to summarize larger data sets with a small number of values, indicating the central tendency and spread of the data.  Commonly used statistics will be defined and compared, including mean, geometric mean, median, mode for central tendency and variance, standard deviation, %CV, interquartile range for spread.

Session 3: Statistical Plots

Statistical Plots

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: A picture is worth a thousand words.  Histograms, boxplots, and other statistical plots are the visual extension of descriptive statistics.  We will examine standard statistical plots and how to use them to check distributional assumptions or for outliers.

Session 4: Hypothesis Testing

Hypothesis Testing

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: Developing a hypothesis and designing an experiment to test the hypothesis are basic steps in scientific method.  Statistical hypothesis testing provides a framework for the data analysis used to evaluate experimental data.  We will define the null and alternative hypotheses, consider several simple hypothesis tests and when to use them, and relate hypothesis tests to confidence intervals.

Session 5: ANOVA (1-Way & 2-Way)

ANOVA (1-Way & 2-Way)

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: ANOVA models are the workhorse of statistics.  These flexible models are used for many purposes, from comparing treatment and control group means to characterizing sources of variability in a bioassay validation.  Using one-way and two-way ANOVA models, we will explore the differences between fixed effects and random effects models, and how to interpret the statistical output from these models.

Session 6: Linear Regression

Linear Regression

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: Understanding simple linear regression provides a basis for the more complex models used for potency bioassays.  In this session, we will look at the relationship between correlation and regression, how residuals and r2 are calculated and interpreted in linear models, and how to interpret residual plots.  Parallelism and relative potency will be introduced in the context of linear models.

Session 7: The 4PL Model

The 4PL Model

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: The 4PL model is the workhorse of bioassay.  To gain a better understanding of this model, we will develop the 4PL model in the context of a relative potency bioassay and review the standard output from bioassay software.  The extension of parallelism in a linear model to similarity in a 4PL model will be illustrated.

Session 8: Understanding the Guidance on System Suitability and Sample Suitability (Part 1)

Understanding the Guidance on System Suitability and Sample Suitability (Part 1)

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: The USP recommends establishing system suitability criteria prior after development, but prior to bioassay validation. System suitability criteria are typically applied to the reference standard or control samples (not test samples) to assess the validity of an assay or run. We will review the USP guidance on assessing model fit and precision, the use of equivalence tests and tolerance intervals for system suitability, and the use of historical assay data to establish system suitability criteria.

Session 9: Understanding the Guidance on System Suitability and Sample Suitability (Part 2)

Understanding the Guidance on System Suitability and Sample Suitability (Part 2)

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: The USP recommends equivalence testing to assess similarity/parallelism of the test sample to the reference standard. We will define the null and alternative hypotheses for equivalence tests (vs. classical hypothesis tests or difference tests). The two one-sided test (TOST) for equivalence can be implemented quite simply using 90 percent confidence intervals. We will consider appropriate measures of similarity for linear and 4PL models in relative potency bioassays and the use of historical data to establish equivalence regions.

Session 10: Combining Results from Multiple Assays

Combining Results from Multiple Assays

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: Replicate measurements on a test sample are used to provide a better estimate of the reportable value, improving both precision and accuracy of the reportable value.  We will review the USP guidance on combining results from multiple assays to obtain a reportable value, and the approaches to calculating confidence intervals.

Session 11: Assay Validation

Assay Validation

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: The culmination of bioassay development is demonstrating that the assay performance is suitable for the intended use.  We will present design of experiments or DOE in the context of bioassay validation and the use of statistical models to characterize intermediate precision and relative accuracy through dilutional linearity.

Session 12: SPC – Monitoring Your Assay Over Time

SPC – Monitoring Your Assay Over Time

  • Instructor: Nancy Niemuth M.S.
  • Format: On-demand recording available now.
  • Content: Statistical Process Control (SPC) is used to monitor assay performance and ensure stability. In contrast to system suitability, which considers the individual assay, SPC tracks assay performance over time. When things go wrong, SPC can help you find them. Basics of control charting and pattern analysis rules will be introduced.

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.