The Institute for Scientific Exchange, Inc. Presents:

 

ISE Training Courses in Drug Development:

June 19, 2006

Seattle, WA, USA

Symposium Venue:  Edgewater Hotel

 

Monday, June 19, 2006

 

Applied Pharmacokinetics (PK) in Supporting Drug Discovery and Pre-clinical Development

 

Hua Yang, Ph.D.

Sr. Scientist II

Millennium Pharmaceuticals, Inc

45 Sidney Street

Cambridge, MA 02139

yang@mpi.com

 

Course Description:  A comprehensive 4 hour course on the basic PK concepts and apply PK concepts to drug discovery and pre-clinical development.  The course will cover the basic PK data analysis methods, the major considerations when design a discovery or pre-clinical PK studies, basic methods of human PK projection and human efficacious dose projection, the first in human dose projection, and major PK (TK) factors in safety assessment.  The course is designed for scientists in pharmacology, toxicology, chemistry, pharmaceutical science and related field who intend to apply in vivo PK concepts in support drug discovery and preclinical development.

 

Length of Lecture:  ½  hours

Course Syllabus:

 

7:00 AM – 5:00 PM – Registration

 

1:30 PM – 5:30 PM 

 

Introduction and Basic PK Concepts

 

  1. Introduction
  2. Basic pharmacokinetics concepts

Absorption

Distribution and volume of distribution

Clearance concepts, hepatic clearance and renal clearance

Compartment modeling

Intravenous bolus dose

Extravascular single dose

Bioavailability

Intravenous infusion

 

Introduction to PK Data Analysis, Basic PK Study Design

 

      3.   Excel and graphics (with exercise)

WinNonlin 

compartment vs non-compartment analysis

use of simulation

 

  1. Basic PK study design

Select PK species

Select PK route of administration

Exposure measurement

T1/2 and duration of action

 

Human PK and Human Efficacious Dose Projection

 

5.   PK/PD studies supporting human PK/Human dose projection

      PK studies in animal species

PK/PD studies

Data analysis and results interpretation

Human PK projection (allometric scaling and others)

Human efficacious dose projection

 

PK (TK) Studies Supporting Safety Assessment

 

6.   Tox species selection

      Exposure and metabolite considerations

TK study design

How to decide the FIM dose (with exercise)

Concerns for the bioanalytical assay in PK and TK studies

 

Summary of lecture and open discussion

 

END OF COURSE