Wednesday, 26 June 2013

Clinical Trials - Pharmacokinetics and Bioequivalence

How quickly does the human body absorb a drug?  What are the effects of different doses?  Pharmaceutical companies study these issues in small, early-phase studies that, before they undertake a large randomized study of a drug's safety and efficacy.  Learn more in "Clinical Trials - Pharmacokinetics & Bioequivalence," which will be taught online by Dr. Vidyadhar Phadke at For more details please visit at

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.

Who Should Take This Course:
Analysts responsible for designing, implementing or analyzing clinical trials.

Course Program:

Course outline: The course is structured as follows



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)
o    end point
o    question of interest
o    choice of statistical technique
o    interpretation
  • Illustrative analysis of two cases

SESSION 2: Pharmacokinetics (PK) and Bioavailability
  • Basic concepts of PK
  • PK analysis of time-concentration data (bioavailability assessment)
o    Oral administration
o    Estimation of Cmax, Tmax, AUC, Ke, Ka
o    Intravenous administration
  • Dose-response modeling
o    Types of 
      • Michaelis-Menton model for saturating relationship
      • Power model: A model that includes three shapes



SESSION 3: Inference for Pharmocokinetic (PK) data

  • 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 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 (Cmax)
  • CI approach (Cmax)


Bioequivalence Studies 2 x 2 (Crossover Design)
  • What is crossover design?
  • Analysis of illustrative data using two sample tests
o    Test for carry over effect
o    Test for period effect
    • Test for treatment difference
  • Testing equivalence using CI
o    Parallel vs. crossover design

Dr. Vidyadhar Phadke is Senior Statistician at Cytel Statistical Software and Services, the leading contract research organization for advanced design of clinical trials.  Dr. Phadke has responsibility for Cytel's industry-leading software for adaptive trials (EaSt) and dose-ranging trials (Compass).

You will be able to ask questions and exchange comments with the instructors via a private discussion board throughout the course.   The courses take place online at in a series of 4 weekly lessons and assignments, and require about 15 hours/week.  Participate at your own convenience; there are no set times when you must be online. You have the flexibility to work a bit every day, if that is your preference, or concentrate your work in just a couple of days.

For Indian participants accepts registration for its courses at special prices in Indian Rupees through its partner, the Center for eLearning and Training (C-eLT), Pune.

For India Registration and pricing, please visit us at

Call: 020 66009116


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