[header_logo.jpg]
Home / Services / Clinical Research & Biostatistics / Quantum Institute of Clinical Research & Biostatistics - QICRB / Course Schedule & Registration / Course Details

Course Details

Course in Pharmacokinetics and Bioequivalence Studies

[register_now_btn.png]
Course ID : QI-PK-201
Date : For May 2017 - Sept 2017 classes, in NJ, USA/Bangalore, India (depending on no. of students): By Arrangement with Instructor(s)
Duration : 5 days intensive In-Class Training; 2 days Instructor in Classroom to assist students complete assignments
Location : New Jersey, USA & Bangalore, India (depending on no. of students)
For Registration/Pricing, call: : Please call our office in New Jersey at 609-454-5635 or email us at info_india@quantument.com for pricing/registration

Introduction

An unsatisfactory pharmacokinetics profile is one of the main causes for failure during drug development. To avoid this, pharmaceutical companies implement pharmacokinetic investigations as part of drug discovery and development. Therefore, a complete understanding of the pharmacokinetics of a drug is critical before it has any chance of reaching the pharmacy. Early clinical trials are carried out to determine the characteristics of pharmacokinetic parameters (to name a couple, maximum drug concentration, Tmax, area under the curve, etc.) of each new pharmacological entity.

Description

Given its importance in drug development process as described in the introduction, this course focuses on such topics as
  • Absorption
  • Distribution
  • Metabolism and Excretion (ADME)
  • Assessment of pharmacokinetic parameters
  • Clearance concepts
  • Pharmacokinetics of Oral Administration
  • Compartmental models
  • Design and conduct of bioequivalence (BE) studies
  • Sample size calculation for BE studies
  • Statistical analysis for determining bioequivalence
  • Reporting and evaluation of bioequivalence studies.
Half-day of hands-on session using the statistical software such as Statistical Analysis Software (SAS), WinNonlin and Excel.

Prerequisite

This course is intended for those who come in contact with pharmacokinetic data as well as anyone who is interested in understanding the basic pharmacokinetic and bioequivalence studies. Previous knowledge of pharmacokinetics is helpful but not required. This course will be of particular benefit for those professionals who are working Preclinical, Phase I, Drug Safety and Data Management &Analysis.

Knowledge of SAS to create and manipulate SAS data set and the use of PROC ANOVA is helpful.

Topics of Study

  • Introduction to Pharmacokinetics
  • One Compartment model
  • Analysis of Urine Data
  • Intravenous Infusion
  • Routes of Administration
  • Pharmacokinetics of Oral Administration
  • Factors Affecting Oral Absorption
  • Multiple Oral Dose Administration
  • Multiple IV Bolus Dose Administration
  • Routes of Excretion
  • Metabolism and Drug Distribution
  • Multi-compartment Pharmacokinetic Models
  • Non-linear Pharmacokinetic Models (Optional)
  • Clinical Applications of Pharmacokinetics (Optional)

Fundamentals of the Bioavailability and Bioequivalence Studies

Topics include:

  • Definition of Bioequivalence (BE)
  • Purpose of BE
  • Approaches to Determining BE (21 CFR 320.24)
  • Study Designs
  • Measurement and Analysis of Pharmacokinetic Parameters
  • Statistical Analysis (Two One-Sided Tests Procedure, BE criteria, etc.)
  • Applications of the Statistical Analysis Software(SAS) to Perform BE Analysis