Clinical Trials - Pharmacokinetics and Bioequivalence

taught by Sharayu Paranjpe
and Anil Gore

Brief Description:

This course covers the statistical measurement and analysis methods relevant to the study of pharmacokinetics (the absorption, distribution and secretion of drugs), dose-response modeling, and bioequivalence.  It 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:
July 27, 2012 to August 24, 2012
ct-pk_babe Click here to be reminded of future sessions of this course.

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

Register Online -$499
Register Online -$399 (you must be affiliated with a college, university or high school)

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. Please use this printed registration form, for these and other special orders.

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. Multiple course registrations may be entitled to tuition discounts; read more.

Share This :

Clinical Trials - Pharmacokinetics and Bioequivalence

taught by Sharayu Paranjpe
and Anil Gore

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), dose-response modeling and bioequivalence. 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.  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.

This course is a core requirement or elective in the following Program(s) in Analytics and Statistical Studies (PASS):

• Biostatistics - Controlled Trials

Prerequisite(s):

The equivalent of Introduction to Statistical Issues in Clinical Trials.

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

HOMEWORK:

Homework in this course consists of short answer questions to test concepts and guided data analysis problems using software.

Organization of the Course:

This course takes place over the internet 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.

The course typically requires 15 hours per week. 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.

Credit:
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:

1. You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
2. You may be enrolled in PASS (Programs in Analytics and Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
3. You may require a "Record of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's).  For those successfully completing the course, 5.0 CEU's and a record of course completion will be issued by The Institute, upon request.

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.

Register Now

Yes, I want to register for:

Clinical Trials - Pharmacokinetics and Bioequivalence

taught by Sharayu Paranjpe
and Anil Gore

Instructor(s):
Dates:
July 27, 2012 to August 24, 2012
Course Fee: $499
Academic 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.

I am affiliated with an academic institution
I am not affiliated with an academic institution