Program - Society of Toxicology

44 th Annual Meeting
and ToxExpo
Continuing Education
DEVELOPMENT AND INTERPRETATION OF TOXICOKINETIC
DATA FOR RISK AND SAFETY ASSESSMENT
PM 09
ADVANCED
Chairperson(s): John Lipscomb, U.S. EPA / ORD, Cincinnati, OH and Jos
Bessems, TNO, Zeist, Netherlands.
Endorsed by:
Regulatory and Safety Evaluation SS
Risk Assessment SS*
Student Advisory Committee
Drug development and environmental health risk assessment activities are based
on knowledge of chemical disposition and tissue interactions, that may be separately
considered as toxicokinetics (TK) and toxicodynamics (TD). Each
activity is initiated with valuation of basic toxicity information, including characterizing
effective doses and the dose-response relationship identifying critical
organs, tissues and processes; examining metabolic characteristics and the toxic
nature of metabolites. Each activity culminates with the assessment of TK and
TD relative to the concentration/dose-response relationship. This basic continuing
education course is intended for the general toxicologist desiring to
increase the use of TK data to build compound dossiers, and to address the
needs of scientists designing toxicity and pharmacokinetic studies, preclinical
and clinical studies, and conducting safety and/or risk assessments. Four
lectures will be presented; content will address the design, conduct and evaluation
of studies to inform an understanding of chemical disposition and
effectiveness in the biological system. Instruction will be given on the considerations
of doses and concentrations used in whole-animal toxicity and ADME
studies and in in vitro investigations; the biochemical basis of chemical metabolism
and the considerations and assumptions necessary to interpret metabolism
findings; best use of TK data to inform doses intended for use in TD studies;
extrapolations of effective doses between and among species through the use of
default and chemical-specific uncertainty/adjustment factors; available guidance
on uncertainty factor derivation for human health risk assessment;
overview of PBPK modeling and its application to extrapolations of dose, route
and duration, between and among species; and the basis and results of choice of
classical or PBPK modeling for drug development and risk assessment.
• Use of ADME Data in Toxicity Study Design, Jos Bessems, TNO, Zeist,
Netherlands.
• Combining Toxicokinetic and Toxicodynamic Data for Application in
Drug Development, Rakesh Dixit, Merck Research Laboratories, West
Point, PA.
• Use of Compound Specific and General Kinetic Data in Human Risk
Assessment, John Lipscomb, U.S. EPA / ORD, Cincinnati, OH.
• Physiologically Based Pharmacokinetic Modeling, Hugh Barton,
Research Triangle Park, NC.
PHOTOTOXICITY: CURRENT CONCEPTS, EXPERIMENTAL
DESIGNS, AND REGULATORY EXPECTATIONS
PM 10
BASIC
Chairperson(s): Joseph Tigner, Purdue Pharma L.P., Ardsley, NY and Vincent
A. Murphy, P&G Pharmaceuticals, Inc., Cincinnati, OH.
Endorsed by:
Regulatory and Safety Evaluation SS*
Risk Assessment SS
Exposure to solar ultraviolet and visible radiation produces acute and chronic
skin damage. Chemicals, including pharmaceutical agents, may exacerbate such
effects following topical or systemic exposure. The aim of phototoxicological
testing is to predict the likelihood of such events using various in vivo and in
vitro models. The purpose of this course is to familiarize toxicologists with the
basic concepts of phototoxicological testing. This is especially important in light
of recent U.S. and European regulatory guidances relating to photosafety
testing. The program will describe the comparative anatomy, physiology, and
basic photobiology of the skin, the basic principles and experimental designs
used in phototoxicity testing in nonclinical species and people as well as in vitro
models. The course will also address the most recent regulatory guideline from
the U.S. FDA regarding phototoxicity testing.
• Effect of Light on the Structure and Function of Skin, J.F. Nash, The
Procter & Gamble Co., Cincinnati, OH.
• Phototoxicity, Photocarcinogenicity, and Photoallergy. Study Designs
and Issues, P. Donald Forbes, Argus Research-Charles River, Horsham,
PA.
• Drug Phototoxicity in Humans: A Randomized Controlled Trial
Methodology, James Ferguson, Dundee, Scotland.
• CDER/FDA Photosafety Guidance for Industry, Abigail Jacobs, U.S.
FDA/CDER, Rockville, MD.
CE
up-to-date information at www.toxicology.org 43