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Related Concept Videos

Mutagenicity and Carcinogenicity01:25

Mutagenicity and Carcinogenicity

Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
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Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...

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Improving carcinogenicity assessment.

Daniel Morton1, Todd Bourcier, Carl L Alden

  • 1Pfizer, Inc., Groton, Connecticut, USA. dan.g.morton@pfizer.com

Toxicologic Pathology
|October 19, 2012
PubMed
Summary
This summary is machine-generated.

Regulatory guidance for pharmaceutical carcinogenicity assessment is being revised. Discussions, including the NEGCARC proposal, focus on updating strategies for drug safety evaluation.

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Area of Science:

  • Pharmacology and Toxicology
  • Regulatory Science

Background:

  • International Council for Harmonisation (ICH) initiated revisions to pharmaceutical carcinogenicity assessment guidelines in June 2012.
  • Discussions were partly influenced by the Negative for Endocrine, Genotoxicity, and Chronic Study Associated Histopathologic Risk Factors for Carcinogenicity in the Rat (NEGCARC) proposal from PhRMA.

Framework:

  • The 2012 STP Town Hall Meeting highlighted the necessity for evolving carcinogenicity assessment methodologies in drug development.
  • The International Council for Harmonisation (ICH) Expert Working Group S1 is actively discussing modifications to existing regulatory guidelines.

Implementation:

  • Dr. Todd Bourcier, representing the U.S. FDA and its Alternative Carcinogenicity Assessment Committee, was a key speaker and panelist.
  • The panel included experts such as Drs. Carl Alden and Dan Morton, contributing to the dialogue on regulatory changes.

Implications:

  • These revisions aim to enhance the accuracy and efficiency of pharmaceutical carcinogenicity evaluations.
  • Updated regulatory guidance will impact drug development pathways and safety assessments for new pharmaceutical products.