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Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends

Dr. Susanne Stalford, Lhasa Principal Scientist, presented within a Pharmaceutical & BioScience Society workshop, on the topic of Nonclinical Carcinogenicity Studies.

The workshop included presentations from regulatory and industry perspectives, on topics relating to carcinogenicity assessment of pharmaceuticals, including:

  • The challenges faced with carcinogenicity assessments, in the development of pharmaceuticals
  • Regulatory and industry perspectives on the ICH S1B(R1) carcinogenicity guideline
  • Protocols to support an ICH S1B weight of evidence (WOE) assessment
  • High dose selection by clinical exposure rations, in the rasH2-Tg mouse study
  • Use of a carcinogenicity adverse outcome pathway (AOP) network to conduct a WOE assessment.

Susanne’s contribution was to the topic of using of a carcinogenicity AOP network to conduct an ICH S1B WOE assessment, which included a case study example.

Please get in touch for access to the presentation.