Clinical Trials – Pharmacokinetics and Bioequivalence
This course will teach you the statistical measurement and analysis methods relevant to the study of pharmacokinetics, dose-response modeling, and bioequivalence. The course provides practical work with actual/simulated clinical trial data.
Overview
This primarily case-oriented course covers statistical measurement and analysis methods relevant to the study of pharmacokinetics (the absorption, distribution and secretion of drugs), dose-response modeling and bioequivalence. You will apply the principles of designing and analyzing clinical trials to the circumstances of several actual trials and acquire case oriented, “hands-on” practice in this demanding field. Computations will require use of some statistical software, students can use any software convenient to them.
- Intermediate
- 4 Weeks
- Expert Instructor
- Tuiton-Back Guarantee
- 100% Online
- TA Support
Learning Outcomes
After taking this course, students will be able to specify the design of a new drug or new device study with the goal of establishing whether the new protocol is statistically equivalent to an existing therapy. You will learn how to design a study in accordance with regulatory requirements, as well as appropriate methods for analyzing data. You will be able to fit statistical models to dose-response data with the goal of quantifying a reliable relationship between drug dosage and average patient response.
- Conduct PK analysis of time-concentration data
- Conduct dose-response analysis
- Specify bioequivalence designs for parallel and crossover designs
- Review actual clinical trials and identify end point, question of interest, statistical method used
Who Should Take This Course
Analysts responsible for designing, implementing or analyzing clinical trials.
Our Instructors
Dr. Nand Kishore Rawat
Course Syllabus
Week 1
Clinical Trials for Drugs and Devices
- Clinical trials review
- Four trials of drugs and devices, behavioral therapy and chiropractic therapy (two examined in the lesson, two for homework)
- end point
- question of interest
- choice of statistical technique
- interpretation
- Illustrative analysis of two cases
Week 2
Pharmacokinetics (PK) and Bioavailability
- Basic concepts of PK
- PK analysis of time-concentration data (bioavailability assessment)
- Oral administration
- Estimation of Cmax, Tmax, AUC, Ke, Ka
- Intravenous administration
- Dose-response modeling
- Types of dose-response relationships
- Michaelis-Menton model for saturating relationship
- Power model: A model that includes three shapes
- Types of dose-response relationships
Week 3
Bioequivalence
- Normality testing of PK parameters (AUC, Cmax)
- Transformations for achieving normality (AUC, Cmax)
- Parametric (AUC, Cmax) and Non-parametric tests (Tmax)
- Bootstrap confidence interval for t1/2
- Analysis of Does-Response Data
- Estimation of median effective dose
- Testing of dose proportionality in power model
Week 4
Bioequivalence Studies-Parallel Design
- Statistical equality vs. clinical equivalence
- Testing bioequivalence (AUC)
- CI approach (AUC)
- Testing bioequivalence (Cmax)
- CI approach (Cmax)
Bioequivalence Studies 2 x 2 (Crossover Design)
- What is crossover design?
- Analysis of illustrative data using two sample tests
- Test for carry over effect
- Test for period effect
- Test for treatment difference
- Testing equivalence using CI
- Parallel vs. crossover design
Class Dates
2023
Instructors:
Prerequisites
Introduction to Statistical Issues in Clinical Trials
- Skill: Intermediate
- Credit Options: CEU
The Statistics.com courses have helped me a lot, pushing me to the limit and making me learn much more than I expected I could. The knowledge I gained I could immediately leverage in my job … then eventually led to landing a job in my dream company – Amazon.
Karolis Urbonas
This program has been a life and work game changer for me. Within 2 weeks of taking this class, I was able to produce far more than I ever had before.
Susan Kamp
The material covered in the Analytics for Data Science Certificate will be indispensable in my work. I can’t wait to take other courses. Great work!
Stephen McAllister
I learned more in the past 6 weeks than I did taking a full semester of statistics in college, and 10 weeks of statistics in graduate school. Seriously.
Amir Aminimanizani
This is the best online course I have ever taken. Very well prepared. Covers a lot of real-life problems. Good job, thank you very much!
Elena Rose
The more courses I take at Statistics.com, the more appreciation I have for the smart approach, quality of instructors, assistants, admin and program. Well done!
Leonardo Nagata
This course greatly benefited me because I am interested in working in AI. It has given me solid foundational knowledge…After completing this last course, I feel I have gained valuable skills that will enhance my employability in Data Science, opening up diverse career opportunities.
Richard Jackson
Frequently Asked Questions
-
What is your satisfaction guarantee and how does it work?
-
Can I transfer or withdraw from a course?
-
Who are the instructors at Statistics.com?
Visit our knowledge base and learn more.
Register For This Course
Clinical Trials – Pharmacokinetics and Bioequivalence
Additional Information
Homework
Homework in this course consists of short answer questions to test concepts and guided data analysis problems using software.
In addition to assigned readings, this course also has supplemental readings available online.
Course Text
All necessary course materials will be provided during the course.
Software
Computations involved would require use of some statistical software. Participants can use any software convenient to them. Instructors will generally use MINITAB and occasionally S+.
Supplemental Information
Literacy, Accessibility, and Dyslexia
At Statistics.com, we aim to provide a learning environment suitable for everyone. To help you get the most out of your learning experience, we have researched and tested several assistance tools. For students with dyslexia, colorblindness, or reading difficulties, we recommend the following web browser add-ons and extensions:
Chrome
- Color Enhancer (for colorblindness)
- HelperBird (for colorblindness, dyslexia, and reading difficulties)
Firefox
- Mobile Dyslexic
- Color Vision Simulation (native accessibility feature)
- Other native accessibility features instructions
Safari
- Navidys (for colorblindness, dyslexia, and reading difficulties)
- HelperBird for Safari (for colorblindness, dyslexia, and reading difficulties)
Register For This Course
Clinical Trials – Pharmacokinetics and Bioequivalence