Categories: Advanced Diploma in Biostatistics and Computing
      Date: Jun 21, 2010
     Title: Course in Pharmacokinetics and Bioequivalence Studies

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
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

Fundamentals of the Bioavailability and Bioequivalence Studies

Topics include:

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