Clinical Trials - Pharmacokinetics and Bioequivalence
taught by Vidyadhar Phadke and Nand Kishore RawatAim of Course:
This online course, "Clinical Trials - Phamacokinetics and Bioequivalence" covers the statistical measurement and analysis methods relevant to the study of pharmacokinetics (the absorption, distribution and secretion of drugs), dose-response modeling and bioequivalence. In this course, you will apply the principles of designing and analyzing clinical trials to the circumstances of several actual trials. This course is primarily case oriented and will give you the "hands-on" practice required in this demanding field. After taking this course, participants will be able to specify the design of a new drug or new device study, with the goal of establishing whether the new drug or device is statistically equivalent to an existing therapy. This includes designing the study in accordance with regulatory requirements, as well as appropriate methods for analyzing data. Participants will also 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.
This course may be taken individually (one-off) or as part of a certificate program.Course Program:
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
- 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: Inference for Pharmocokinetic (PK) data
- 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 Dose-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
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.
Clinical Trials - Phamacokinetics and BioequivalenceWho Should Take This Course:
Analysts responsible for designing, implementing or analyzing clinical trials.Level:
The equivalent of Introduction to Statistical Issues in Clinical Trials.
Organization of the Course:
This course takes place online at the Institute for 4 weeks. During each course week, you participate at times of your own choosing - there are no set times when you must be online. Course participants will be given access to a private discussion board. In class discussions led by the instructor, you can post questions, seek clarification, and interact with your fellow students and the instructor.
At the beginning of each week, you receive the relevant material, in addition to answers to exercises from the previous session. During the week, you are expected to go over the course materials, work through exercises, and submit answers. Discussion among participants is encouraged. The instructor will provide answers and comments, and at the end of the week, you will receive individual feedback on your homework answers.
About 15 hours per week, at times of your choosing.
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:
- You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
- You may be enrolled in PASS (Programs in Analytics and Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
- You may require a "Record of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's). For those successfully completing the course, CEU's and a record of course completion will be issued by The Institute, upon request.
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+. For more information about obtaining free or nominal cost versions of standard software packages, click here.
Clinical Trials - Phamacokinetics and Bioequivalence
Course Fee: $589
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