Clinical Trials - Pharmacokinetics & Dose Response Modeling

Brief Description:

This course covers the statistical measurement and analysis methods relevant to the study of pharmacokinetics (the absorption, distribution and secretion of drugs) and dose-response relationships.

Instructor(s):
Level: intermediate

Who Should Take This Course:

Analysts responsible for designing, implementing or analyzing clinical trials.

Dates:
All courses have already commenced.
Click here to be reminded of future sessions of this course.

Registration:
Please read the syllabus tab, noting the prerequisites, text and software requirements.

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Clinical Trials - Pharmacokinetics & Dose Response Modeling

Aim of Course:

This course covers the statistical measurement and analysis methods relevant to the study of pharmacokinetics (the absorption, distribution and secretion of drugs) and dose-response relationships. 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.

Prerequisite(s):

The equivalent of Introduction to Statistical Issues in Clinical Trials. See registration for 3-course tuition package.

Course Program:

PK Dose

SESSION 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

SESSION 2: Pharmacokinetics (PK) and bioavailability

• Basic concepts of PK
• PK analysis of time-concentration data (bioavailability assessment)
  • Oral administration
  • Estimation of C_max, T_max, AUC, K_e, K_a
  • Intravenous administration
• Dose-Response Modeling
  • Types of dose-response relationships
    • Michaelis-Menton model for saturating relationship
    • Power model: A model that includes three shapes

Bioequivalence

SESSION 3: Inference for Pharmocokinetic (PK) data

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

Analysis of Dose-Response Data

• Estimation of median effective dose
• Testing of dose proportionality in power model

Session 4: Bioequivalence Studies-Parallel Design

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

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:

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.

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Clinical Trials - Pharmacokinetics & Dose Response Modeling

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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