Module 5 Presentations

16/07/2024

Hazard Identification & Characterisation CHARACTERISATION OF TOXIC EFFECTS (ICH “S”)

• Undesirable pharmacodynamic effects on body systems • Gene mutation and chromosome damage

Safety Pharmacology (S7)

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Genetic toxicity (S2)

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• Target organ toxicity/local tolerance

• Single/repeat dose toxicity (S4)

• Fertility, Development, parturition, and post-natal development

Reproductive Toxicology (S5)

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Carcinogenicity

Carcinogenicity (S1)

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Exposure & metabolism

Toxicokinetics (S3)

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Special studies

• Local tolerance, Immunotox (S8), Phototox (S10), Juvenile (S11), Environmental, Health & safety

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The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

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APPLYING THE RISK ASSESSMENT

Initial non-clinical safety studies should help define:

• safe starting dose for human trials •safe upper limits • monitoring parameters for adverse effects

Healthy volunteers

Provide reassurance & build confidence to proceed ...........

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

10

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