SBS315: Regulatory Toxicology
Lecture 14
Metabolism and ic
studies
Dr Nick Plant
Introduction
• Drugs must do what they say
• Must not do what they don’t say
• Drug is only effective if the following are
correct
– Dose
– Dose interval
– Clinical Efficacy
• Drugs were originally prescribed based on
an ‘effect-only’ basis
• Is this a problem?
Why PK/PD?
• Provide a simplified description of the
observations
• Important in decision making for drug
regulation
• Can help set dose, dosing interval and
clinical efficacy
• Complement clinical endpoint data in
modifying dosing regimes
• Useful in answering research questions
(all ADME)
PK/PD models: Antibiotics
• PD/PK data is important in deciding which are
the impo
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