Module 9 2024

03/09/2024

Post-FIH Nonclinical Toxicology Requirements

The Organisation for Professionals in Regulatory Affairs

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Nonclinical testing of biologics Post-FIH Testing

Chronic Repeat Dose Toxicity Study :

• Longest duration toxicity study is 26 weeks dosing regardless of species (supports lifetime dosing) • Timing triggered by clinical dosing duration – could be very early or very late in drug development • Assessments generally mimic those for the first FIH-enabling tox study but also allows focus on potential or known toxicities and any specialised analyses to be included • If NHP, sexually mature males and females used to allow assessment of potential impact on fertility

• Menstrual cycling and hormone monitoring

• Testicular & sperm evaluation (weight, size, sperm motility, morphology etc)

• Histopath of reproductive organs

The Organisation for Professionals in Regulatory Affairs

Preclinical Testing of Biologicals – Sept 2024

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