Clinical Trials-Bioavailability and Bioequivalence

Brief Description:

This course covers the topics of bioequivalence and dose-response modeling, and provides practical work with actual/simulated clinical trial data.

Instructor(s):
Level: intermediate

Who Should Take This Course:

Analysts responsible for designing, implementing or analyzing clinical trials.

Dates:
All courses have already commenced.
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Registration:
Please read the syllabus tab, noting the prerequisites, text and software requirements.

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Clinical Trials-Bioavailability and Bioequivalence

Aim of Course:

This course covers the topics of bioequivalence and dose-response modeling, and provides practical work with actual/simulated clinical trial data. 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.

Prerequisite(s):
The equivalent of Introduction to Statistical Issues in Clinical Trials and Clinical Trials Statistics - Pharmacokinetics & Dose.
Course Program:

SESSION 1: Inference for Pharmocokinetic (PK) data

• Normality testing of PK parameters (AUC, C_max)
• Transformations for achieving normality (AUC, C_max)
• Parametric (AUC, C_max) and Non-parametric tests (T_max)
• Bootstrap confidence interval for t_1/2

SESSION 2: Analysis of Dose-Response Data

• Estimation of minimum effective dose
• Estimation of median effective dose
• Estimation of maximum effective dose
• Testing of dose proportionality in power model
• Step wise procedure for dose proportionality range

SESSION 3: Bioequivalence Studies-Parallel Design

• Statistical equality vs. clinical equivalence
• Testing bioequivalence (AUC)
• CI approach (AUC)
• Testing bioequivalence (C_max)
• CI approach (C_max)

SESSION 4: 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

Course Text:

All necessary course materials will be provided during the course.

Software:

Work in the course will require the use of standard statistical software. Participants can use any of the standard packages they are familiar with (SAS, Minitab, R, SPSS, Stata, etc.) Instructors and/or TA's are familiar with these packages. Instructors will generally use MINITAB and occasionally S+. For more information about obtaining free or nominal cost versions of standard software packages, click here.

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Clinical Trials-Bioavailability and Bioequivalence

Instructor(s):
Dates:
All courses have already commenced.
Course Fee: $499
Academic Discounted Rate: $399

Before registering, please read the syllabus tab, noting the prerequisites, text and software requirements. When you click the register button, you will be taken to our secure transaction page.

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