A fit-for-purpose QCP development strategy leverages the relevant clinical pharmacology principles across the spectrum of drug development and evaluation to promote therapeutic optimisation to help the right patient receive the right drug, at the right dose, and at the right time.
A well-articulated development plan typically comprises the following components:
• Population PK, PK-PD:
Mathematical models are derived to predict drug exposure and response in humans based on preclinical data and clinical studies. PK/PD modelling supports optimal dosing schedules and quantifies benefit risks on drug response by identifying relevant intrinsic and extrinsic patient characteristics.
• Clinical trial design
QCP can inform the design of clinical trials by providing insights into appropriate patient populations, dosing regimens, and endpoints. PK/PD modelling can also be used to guide the selection of biomarkers and surrogate endpoints that can be used to assess drug safety & efficacy.
• Exposure-response analysis
QCP can be used to evaluate the relationship between drug exposure and clinical outcomes. This can help optimise dosing regimens, assess the impact of patient factors on drug response, and identify subpopulations that may require different dosing strategies.
• Risk assessment
QCP can help identify potential safety risks associated with a new drug or therapy. This includes evaluating the risk of adverse events based on PK/PD modelling, as well as identifying patient populations that may be at increased risk for adverse events.
• Regulatory strategy
QCP can inform regulatory strategy by providing quantitative data to support the safety and efficacy of a new drug or therapy. This can include PK/PD modelling and simulation, exposure-response analysis, and risk assessment.
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