Pharmacodynamics & Pharmacokinetics: PI and PIL considerations

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Pharmacodynamics & Pharmacokinetics: Pharmacodynamics & Pharmacokinetics: PI and PIL considerations PI and PIL considerations Douglas W Oliver School of Pharmacy / Unit for Drug Research & Development SAAPRA 16 November 2012

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Pharmacodynamics & Pharmacokinetics: PI and PIL considerations. Douglas W Oliver School of Pharmacy / Unit for Drug Research & Development. SAAPRA 16 November 2012. Presentation. Introduction: Drug Discovery Research Background: PK/PD Pharmacodynamics (CTD Modules 4&5) Pharmacokinetics - PowerPoint PPT Presentation

Transcript of Pharmacodynamics & Pharmacokinetics: PI and PIL considerations

Page 1: Pharmacodynamics & Pharmacokinetics: PI and PIL considerations

Pharmacodynamics & Pharmacokinetics:Pharmacodynamics & Pharmacokinetics:PI and PIL considerationsPI and PIL considerations

Douglas W OliverSchool of Pharmacy / Unit for Drug Research &

Development

SAAPRA 16 November 2012

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Presentation

• Introduction: – Drug Discovery Research

• Background: PK/PD• Pharmacodynamics

– (CTD Modules 4&5)• Pharmacokinetics

– (CTD Modules 4&5)• Specific Considerations• MCC

– Regulatory Framework• Additional Information• Conclusion

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INTRODUCTION AND

BACKGROUND

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The human

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