# Basic Statistics and Practical Pharmaceutical Applications

This 100% online course explores basic statistics and pharmaceutical applications in the industry. The curriculum focuses on the efficient and practical use of statistics in the pharmaceutical industry. Real world examples will be used to illustrate statistical concepts. Appropriate use of statistics and the interpretation of their results is emphasized. The course also presents an overview of basic elements associated with statistical tests and their practical application. Students will get to work with numerous examples using excel throughout the program.

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin- Madison

Refund Policy

#### Course Objectives

This asynchronous distance education course is designed to provide non-statisticians with practical information needed to apply basic statistical tests to problems typically faced in pharmaceutical industry.  Emphasis will be placed on the most commonly utilized statistical tests, including:

1. t-tests
2. analysis of variance and post hoc procedures
3. measures of repeatability and reproducibility
4. chi square and related tests
5. correlation
6. linear regression
7. major nonparametric procedures
8. outlier tests

The course focuses on the efficient utilization of statistics; not abstract theory. Practical examples drawn from scientific research will be used to illustrate statistical concepts. Emphasis will be placed on the appropriate use of statistics and the interpretation of their results and presents an overview of basic elements associated with statistical tests and their practical application. Numerous examples using Excel will be presented throughout the program.

Goals and Objectives (each lecture will have its own set of learning objectives):

Upon completion of the program the learner will be able to:

1. Define statistical terms commonly encountered in the literature;
2. List the various graphic and numeric methods for presenting descriptive statistics;
3. Describe various distributions, practical applications of probability, and the measures of central tendency;
4. Explain the use of hypothesis testing, significance testing, and sampling procedures;evaluate example problems to identify the type of variables involved and the most appropriate statistical test(s) to use;
5. Interpret statistical output from computer generated results and evaluate the relative importance of those outcomes; and
6. Use Excel to evaluate pharmaceutical data.

#### Who Should Attend

This asynchronous distance education course is designed to provide non-statisticians with practical information needed to apply basic statistical tests to problems typically faced in pharmaceutical industry.

• Junior scientists who do not have a biostats background
• Lab based staff who perform routine biostats analyses
• Anyone who would like a refresher on basic inferential statistics

#### Course Outline

 Lecture 1 An Introduction and Defining Variables Objectives: Upon completion of this unit the learner should be able to: Differentiate between descriptive and inferential statistics; Determine if a variable is continuous or discrete; Identify independent and dependent variables in a statistical problem set; and Initiate the Excel data analysis option. Lecture 2 Descriptive Statistics Objectives: Upon completion of this unit the learner should be able to: List the ways to describe information for sample data for a discrete variable; List the ways to describe the central tendencies for a continuous variable sample; and Use Excel to produce descriptive statistics for continuous data. Lecture 3 Sampling Objectives:  Upon completion of this unit the learner should be able to: Discuss the advantages of using a random sample; Use a random numbers table to select a sample; and List probabilistic sampling methods Lecture 4 An Introduction to Probability Objectives:  Upon completion of this unit the learner should be able to: Discuss the ways to determine probability for an event; Explain conditional probability; Differentiate between combinations and permutations; and Describe and apply the binomial distribution. Lecture 5 Confidence Intervals and Tolerance Limits Objectives:  Upon completion of this unit the learner should be able to: Describe the use of sample data to estimate population parameters; Differentiate between the standard deviation and standard error for sample data; Create confidence intervals using sample data when the population standard deviation is known or can be estimated; and Describe tolerance intervals and how they differ from confidence intervals. Lecture 6 Hypothesis Testing Objectives:  Upon completion of this unit the learner should be able to: Describe the difference between a null hypothesis and an alternative hypothesis; Define Type I and Type II errors in hypothesis testing; and List four factors that influence the power of a statistical procedure. Lecture 7 Student t-tests Objectives:  Upon completion of this unit the learner should be able to: Define the degrees of freedom for a one-sample, two-sample t-test and paired t-test; Calculate a confidence interval based on sample descriptive statistics; Determine the significance of continuous dependent data for two levels of a discrete independent variable; Identify paired versus unpaired data; and Use Excel to calculate a two-sample t-test and a paired t-test. Lecture 8 One-way Analysis of Variance and Post Hoc Procedures Objectives:  Upon completion of this unit the learner should be able to: Define the degrees of freedom associated with an analysis of variance; Determine the significance of continuous dependent data for more than two levels of a discrete independent variable; Use Excel to calculate a one-way analysis of variance; Discuss why post hoc procedures are important in interpreting statistical results; List appropriate post hoc procedure for a significant analysis of variance. Lecture 9 N-way Analysis of Variance and Applications Objectives:  Upon completion of this unit the learner should be able to: Determine the degrees of freedom for an N-way analysis of variance; Expand a two-way ANOVA to a measure of repeatability and reproducibility; and Use Excel to calculate a two-way analysis of variance. Lecture 10 Correlation and Linear Objectives:  Upon completion of this unit the learner should be able to: Define the difference between linear regression and correlation; Identify the type of variables associated with a correlation and contrast with linear regression; Determine the significance of a correlation coefficient; Describe the type of variability that is identified by a regression line; Evaluate the significance a linear regression calculation; and Use Excel to calculate correlation and linear regression Lecture 11 Chi Square and Related Tests Objectives:  Upon completion of this unit the learner should be able to: Describe the use of the chi square test of independence when trying to evaluate the relationship between two discrete variables; Identify the number of degrees of freedom for various sizes of contingency table; Discuss the reasons for using a McNemar test; and Discuss the reasons for using a Fisher’s exact test. Lecture 12 Nonparametric Tests Objectives:  Upon completion of this unit the learner should be able to: Describe the reasons why nonparametric test may be preferred over traditional parametric procedures; Identify nonparametric alternatives for the Student t-tests, one-way ANOVA and correlation; and Discuss the ranking procedure required for most nonparametric procedures. Lecture 13 Drug Product - Analytical Controls for Different Dosage Forms - Setting Specifications for the Certificate of Analysis Objectives:  Upon completion of this unit the learner should be able to: Describe how outlier tests can be used to determine if there is an aberrant value; Define the difference between an outlier and an influential data point; and Apply some of the most commonly used outlier tests

#### Instructors

James E. De Muth, PhD, RPh
Emeritus Professor
School of Pharmacy, University of Wisconsin-Madison

#### Program Coordinator

Eric Buxton, PhD

Division of Pharmacy Professional Development
777 Highland Avenue