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.

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.

$999 | Enroll Now
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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 Level Course
4-Week Course
Expert Instructors
Teacher Assistant Support
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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.

Instructors

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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.

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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

Jul 14, 2023 to Aug 11, 2023

2024

Jul 12, 2024 to Aug 9, 2024

2025

Jul 11, 2025 to Aug 8, 2025

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Prerequisites

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Mapping in R Course

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.
Topic: Statistics, Biostatistics | Skill: Introductory | Credit Options: CEU
Class Start Dates: Jun 9, 2023, Nov 24, 2023, Jun 14, 2024

What Our Students Say​

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The course helps me understand different approaches (pros and cons of each approach) in sample size estimates and provides hands-on experience in using various softwares. I highly recommend this course to folks involved in clinical study design

Dewan Zeng
Director, Clinical Research at Gilead Sciences
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The instructor was exceptional at answering unclear issues raised and pointing you to right materials to further help your understanding

Oluseun Shittu
West London Mental Health NHS Trust
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Frequently Asked Questions

Can I transfer or withdraw from a course?

We have a flexible transfer and withdrawal policy that recognizes circumstances may arise to prevent you from taking a course as planned. You may transfer or withdraw from a course under certain conditions.
  • Students are entitled to a full refund if a course they are registered for is canceled.
  • You can transfer your tuition to another course at any time prior to the course start date or the drop date, however a transfer is not permitted after the drop date.
  • Withdrawals on or after the first day of class are entitled to a percentage refund of tuition.
Please see this page for more information.

Who are the instructors at the Institute?

The Institute has more than 60 instructors who are recruited based on their expertise in various areas in statistics. Our faculty members are:

  • Authors of well-regarded texts in their area;
  • Advisory board members;
  • Senior faculty; and
  • Educators who have made important contributions to the field of statistics or online education in statistics.

The majority of our instructors have more than five years of teaching experience online at the Institute.

Please visit our faculty page for more information on each instructor at The Institute for Statistics Education.

Please see our knowledge center for more information.

What type of courses does the Institute offer?

The Institute offers approximately 80 courses each year. Topics include basic survey courses for novices, a full sequence of introductory statistics courses, bridge courses to more advanced topics. Our courses cover a range of topics including biostatistics, research statistics, data mining, business analytics, survey statistics, and environmental statistics. Please see our course search or knowledge center for more information.

Do your courses have for-credit options?

Our courses have several for-credit options:
  • Continuing education units (CEU)
  • College credit through The American Council on Education (ACE CREDIT)
  • Course credits that are transferable to the INFORMS Certified Analytics Professional (CAP®)
Please see our knowledge center for more information.

Is the Institute for Statistics Education certified?

The Institute for Statistics Education is certified to operate by the State Council of Higher Education for Virginia (SCHEV). For more information visit: https://www.schev.edu/ Please see our knowledge center for more information.

Visit our knowledge base and learn more.

FAQs + Knowledge Base

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This course will teach you the statistical display and analysis methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review.
Topic: Statistics, Biostatistics | Skill: Introductory, Intermediate | Credit Options: CEU
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Sample Size and Power Determination

This course will teach you how to make sample size determinations for various statistical tests and for confidence intervals, as needed for experimental studies such as comparison studies, as well as for other types of experiments.
Topic: Statistics, Biostatistics, Statistical Modeling | Skill: Introductory, Intermediate | Credit Options: CEU
Class Start Dates: Apr 21, 2023, Oct 27, 2023

Additional Course Information

Organization of 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.

Time Requirements

This is a 4-week course requiring 10-15 hours per week of review and study, at times of your choosing.

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+.

Software Uses and Descriptions | Available Free Versions
To learn more about the software used in this course, or how to obtain free versions of software used in our courses, please read our knowledge base article “What software is used in courses?” 

Course Fee & Information

Enrollment
Courses may fill up at any time and registrations are processed in the order in which they are received. Your registration will be confirmed for the first available course date unless you specify otherwise.

Transfers and Withdrawals
We have flexible policies to transfer to another course or withdraw if necessary.

Group Rates
Contact us to get information on group rates.

Discounts
Academic affiliation?  In most courses you are eligible for a discount at checkout.

New to Statistics.com?  Click here for a special introductory discount code.  

Invoice or Purchase Order
Add $50 service fee if you require a prior invoice, or if you need to submit a purchase order or voucher, pay by wire transfer or EFT, or refund and reprocess a prior payment.

Options for Credit and Recognition

This course is eligible for the following credit and recognition options:

No Credit
You may take this course without pursuing credit or a record of completion.

Mastery or Certificate Program Credit
If you are enrolled in mastery or certificate program that requires demonstration of proficiency in this subject, your course work may be assessed for a grade.

CEUs and Proof of Completion
If you require a “Record of Course Completion” along with professional development credit in the form of Continuing Education Units (CEU’s), upon successfully completing the course, CEU’s and a record of course completion will be issued by The Institute upon your request.

Supplemental Information

There is no supplemental content for this course.

Miscellaneous

There is no additional information for this course.

Register for This Course​

Clinical Trials – Pharmacokinetics and Bioequivalence
$999 | Enroll Now
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