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in silico

Human In, Human Out


Description

Welcome to the NURA course Human In, Human Out: Using Primary and Population Data for PBPK Analyses.


In silico models often offer more reliable predictions than the traditional animal-based approaches used throughout regulatory contexts. In this two-part NURA series, scientists and regulatory experts will present their application of PBPK models within a regulatory context, followed by a compelling discussion. You'll learn how we can shift the current standard of Absorption, Distribution, Metabolism, and Excretion studies to a more human-relevant standard.


Speakers:

Eryn Slankster-Schmierer, PhD, Physicians Committee for Responsible Medicine, Moderator

Kiara Fairman, MS, PharmD, National Center for Toxicological Research (NCTR), US Food and Drug Administration (FDA)

Agnes Karmaus, (formerly) Inotiv, supporting NICEATM

Alicia Paini, esqLABS GmbH

John Wambaugh, Center for Computational Toxicology and Exposure, US Environmental Protection Agency (EPA)

Judy Madden, Liverpool John Moores University

Cecilia Tan, Office of Pesticide Programs, US Environmental Protection Agency (EPA)

Dustin Kapraun, Center for Public Health and Environmental Assessment (CPHEA), US Environmental Protection Agency (EPA)

Harvey Clewell, Ramboll US Consulting, Inc


The videos in this course are available with English and Spanish subtitles. To access these, select the "Settings" (gear) icon within the video.

Content
  • Introduction
  • 1.1 Maternal and Maternal-Fetal PBPK Models
  • 1.2 CYP450 integration into the Attagene transcription factor activation assay
  • 1.3 The MOIE concept for derm risk assess: An OECD IATA case study
  • 1.4 Simulating Human Variability in Toxicokinetics with R Package “httk”
  • Section 1 Panel Discussion
  • Section 2 Introduction
  • 2.1 Chemical Space Coverage of PBPK Models
  • 2.2 Overcoming challenges in accepting PBPK models for regulatory applications
  • 2.3 Quality Assurance for Physiologically Based Pharmacokinetic (PBPK) Models
  • 2.4 A brief overview of PBPK platforms
  • Session 2 Panel Discussion
  • Course Survey, Human In Human Out
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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