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Clinical Trials – Pharmacokinetics and Bioequivalence

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

Dr. Nand Kishore Rawat

Dr. Nand Kishore Rawat is a Portfolio Director of Clinical Research Services at Cytel Statistical Software & Services. With his expertise in planning, designing and analysing clinical trial projects, and his experience in clinical trial development at Bristol-Myers Squibb, Novartis, and also noted contract research organizations (CRO’s), he brings a valuable practical perspective to the classroom and gives his students an insightful window into the pharmaceutical clinical trial world. Dr. Nand Kishore Rawat has expertise in planning, designing and analysing clinical trial projects. 

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

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

07/14/2023 to 08/11/2023
Instructors:

Prerequisites

Introduction to Statistical Issues in Clinical Trials

This course will teach you the basic statistical principles in the design and analysis of randomized controlled trials.
  • Skill: Intermediate
  • Credit Options: CEU
Karolis Urbonas
Susan Kamp
Stephen McAllister
Amir Aminimanizani
Elena Rose
Leonardo Nagata
Richard Jackson

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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:

 

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Register For This Course

Clinical Trials – Pharmacokinetics and Bioequivalence