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Making Drug Dosing Decisions Based on Therapeutic Monitoring
Leslie Z Benet1, Jasleen K Sodhi1,2
11Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California, San Francisco, California, USA;
Annual Review of Pharmacology and Toxicology
|August 14, 2026
Summary
This study introduces a new method for pharmacokinetic clearance equations, simplifying drug dosing decisions. This framework allows dosage form design to dictate in vivo clearance for high-clearance drugs.
Area of Science:
- Pharmacokinetics
- Drug disposition
- Pharmaceutical sciences
Background:
- Traditional pharmacokinetic models rely on differential equations or mechanistic models.
- Clinical drug dosing decisions are primarily based on clearance, not rate constants.
- Mass balance is crucial for deriving in vitro measures and rate constants in pharmacokinetics.
Purpose of the Study:
- To present a novel methodology for deriving pharmacokinetic clearance equations.
- To demonstrate the application of this framework in drug dosing decisions using therapeutic drug monitoring.
- To explore implications for pharmaceutical formulation of high-clearance drugs.
Main Methods:
- Review of a new methodology for deriving pharmacokinetic clearance equations.
- Presentation of nine illustrative examples.
- Application of the framework to drug dosing decisions.
Main Results:
- Developed pharmacokinetic clearance equations independent of differential equations or mechanistic models.
- Demonstrated utility in therapeutic drug monitoring for informed dosing decisions.
- Identified potential for dosage form design to control in vivo clearance for high-clearance drugs.
Conclusions:
- The new framework simplifies the derivation of pharmacokinetic clearance equations.
- This approach offers a new paradigm for drug dosing and formulation strategies.
- Pharmaceutical sponsors can potentially design dosage forms where delivery clearance matches in vivo clearance for specific drugs.
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