Dosage is a term used to describe the amount of medication that a patient receives on a regular basis. This is a critical component in the treatment of a disease.
A wide range of factors influences the dosage. These include the weight, age, and clinical state of the patient. Additionally, drug properties, bioavailability, and the route of administration can all influence the dose.
A pharmacokinetic/pharmacodynamic (PK/PD) model can be used to calculate doses that are safe and effective. However, this approach can be challenged by the variability of intra-individual, as well as inter-subject, responses.
Precision dosing is an optimization method that can benefit many patients. Precision dosing is often used to optimize therapeutic outcomes and reduce health care expenditures. It can also be a key tool in addressing sources of pharmacokinetic/pharmacodynamic variability.
Currently, a wide range of research and development efforts are underway to better understand the needs for precision dosing. Several studies have shown that it improves the quality of drug therapy. But a drug’s benefit-risk ratio is a dynamic variable that can change based on the results of new research.
The FDA is promoting several aspects of precision dosing, including expansion cohorts, biomarkers, and the use of models to help characterize drug metabolism and clearance in different patient populations. In addition, the agency is recommending that clinical trials be conducted using a range of doses, which can aid in determining the optimal dose range for the drug.
Despite the growing need for precision dosing, current drug formulations make it difficult to accurately calculate doses. However, a more flexible dosing approach may be achievable.