Spring Intro 2023

Mike Kelly

Bioanalytical method

 Very important to have a robust bioanalytical method ● Regulatory requirement to do full validation including: – precision, accuracy, recovery, selectivity, sensitivity, reproducibility, stability – Regulatory Guidance documents relating to the requirements  Regulatory bodies will perform a thorough review of the bioanalytical method validation at final submission

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Phase I First in Human Studies in Healthy Volunteers

 Information gathered to explore: ● Safety and Tolerability

● Pharmacokinetics – single and multiple dose ● Pharmacodynamics - Biomarkers and AE’s  Single and Multiple Ascending Dose studies  Subjects ● Small numbers of Healthy volunteers – Patients can be used in oncology  Studies are done in controlled Phase 1 units ● Extensive safety testing and PK blood sampling  Enable assessment and understanding of ● PK parameters including variability within & between subjects ● Identify the exposure or dose that relates to toxicity or adverse events ● Generate data to inform dose and dosing regimen in later phases

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