Clinical Trials – Pharmacokinetics and Bioequivalence
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.
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
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
- 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
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
- Skill: Intermediate
- Credit Options: CEU
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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.
All necessary course materials will be provided during the course.
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+.
Literacy, Accessibility, and Dyslexia
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