CRED Understanding Clinical Development 2024

08/10/2024

Preclinical to clinical transition

Safety pharmacology

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Before phase I

CV, respiratory and CNS effects

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Pharmacokinetics

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ADME in animals will be known

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• How does this relate to ADME in man?

Toxicology

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• What type and duration of data are needed to support which clinical trials?

• Should clinical trials with a single microdose be considered?

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Preclinical to clinical transition (continued)

Genotoxicity

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• In vitro tests for gene mutation and chromosomal damage prior to phase I

• Full battery of genotoxicity tests before phase II

Reprotoxicology

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• Not needed in phases I & II for men or for WOCBP

Biotechnology drugs and ATMPs

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Tissue cross-reactivity

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Immunogenicity

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