Spring Intro 2023

Mike Kelly

Closing Remarks: 1

 Covered overview of basic pharmacokinetics and pharmacodynamics ● General Pharmacokinetic characteristics ● Discussed the importance of generating and combining pharmacokinetic/pharmacodynamic information to understand – Exposure - response relationship – Factors that influence exposure and therefore influence response ● Throughout all phases of drug development ● To inform and influence the drug development strategy ● Importantly, to justify and understanding the dosing regimen

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Closing Remarks: 2

All drugs will undergo expert review by the regulatory agencies  Review: ● Scientific rationale and regulatory strategy ● Study design

– Do the designs adhere to the Guidelines ● Pharmacokinetic/statistical methods ● Interpretations/conclusions

● Consistency within and between studies ● Justification of dose and dosing regimen – Exposure response relationships  Comment on ● Bioanalytical method development and validation including - precision, accuracy, recovery, selectivity, sensitivity, reproducibility, stability ● Animal to man pharmacokinetics extrapolation/consistency

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