Dosing definition
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Understanding Dosing: Definitions and Applications
Precision Dosing in Drug Labeling
Precision dosing is defined as the prescription of a therapeutic drug tailored to an individual's characteristics such as age, sex, weight, race/ethnicity, genotype, laboratory markers, and drug concentrations. This approach contrasts with the traditional "one size fits all" method, which focuses on a single recommended dose for all patients. Precision dosing involves a quantitative model that correlates the drug dose in a specific patient to the probability of achieving a therapeutic target, such as a desired outcome or avoiding adverse effects1.
Operationalization of Dose in Health Interventions
In health promotion interventions, the concept of dose is understood as the "amount" of an intervention delivered or received. However, there is significant variation in how dose is defined and measured. It can relate to the level of participation, the quality of intervention delivery, or the amount of intervention. This variability complicates the understanding of how interventions produce their effects and how they are resourced and scaled up. The terms "dose" and "dosage" are often used interchangeably, though "dosage" can capture changes in the amount dispensed over time in response to achieved effects2.
Dosage Forms and Routes of Administration
Drug dosing refers to the quantity of a drug administered to achieve an optimal therapeutic effect with the lowest possible dose. The choice of dosage form and route of administration is crucial and depends on the nature of the disease or illness. For instance, intravenous administration involves injecting the drug directly into a vein, while inhalants are carried by air into the nasal passage. The median effective dose is the quantity that produces 50% of the desired therapeutic intensity in a given patient population3.
Precision Dosing Framework and Public Health Impact
The adoption of precision dosing is facilitated by the widespread use of electronic health record (EHR) systems, which help tailor drug treatment regimens based on patient-specific factors. This approach aims to improve therapeutic outcomes by considering individual variability in drug response and disposition4.
Standardizing Dosing in Behavioral Interventions
In behavioral interventions, dosing is characterized by parameters such as duration, frequency, and amount. Standardized terminology and reporting of these parameters are essential for evaluating dose-response relationships and determining the optimal dose for intervention dissemination. Improved reporting can inform the identification of the most effective intervention doses and facilitate efficient implementation in clinical practice5.
Industry Perspective on Precision Dosing
The pharmaceutical industry traditionally recommends a single dose level for drug approval. However, advances in technology now enable the tailoring of doses to individual patients, addressing the variability in drug response. This shift towards precision dosing is driven by changing expectations from patients, prescribers, and payers6.
Prioritizing Precision Dosing Candidates
The effectiveness and safety of a drug are modulated by the administered dose. Precision dosing is particularly important for drugs that can significantly impact morbidity or mortality. Prioritizing precision dosing candidates involves considering the quality of available information, the level of proof required to change clinical practice, and the cost and effort needed to provide this proof7.
Model-Informed Precision Dosing (MIPD)
Model-informed precision dosing (MIPD) uses patient-specific data and pharmacokinetic models to optimize drug treatment. This approach involves measuring drug concentrations in body fluids and using algorithms to calculate the optimal dose for each patient. MIPD aims to individualize therapy beyond genetic factors, incorporating a broader range of patient characteristics8 10.
Practical Insights into Dosing Practices
Maintaining medication dosing routines, such as for HIV pre-exposure prophylaxis (PrEP), requires coordination of various factors including timing, material objects, and daily routines. Dosing practices are adapted to fit individual life circumstances and manage side effects, highlighting the importance of practical and flexible dosing strategies9.
Conclusion
Dosing, whether in clinical drug administration or health interventions, is a complex and multifaceted concept. Precision dosing, which tailors drug regimens to individual patient characteristics, represents a significant advancement over traditional dosing methods. Standardizing dosing parameters and adopting model-informed approaches can enhance therapeutic outcomes and improve patient care.
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Most relevant research papers on this topic
Supporting Precision Dosing in Drug Labeling
Precision dosing in drug labeling can improve patient outcomes and reduce adverse effects by adjusting drug doses based on individual characteristics.
Rigorous JournalVariation in the operationalisation of dose in implementation of health promotion interventions: insights and recommendations from a scoping review
Dose is not a well-defined or consistently applied concept in health promotion interventions, and should be differentiated from dosage to better capture the dynamic and complex nature of implementation.
Systematic ReviewRigorous JournalDosage Forms and Their Routes of Administration
Proper drug dosage forms and routes of administration are crucial for optimal therapeutic effects, with intravenous administration being efficient and safe, while inhalants can be administered through air currents into the nasal passage.
Precision Dosing: Public Health Need, Proposed Framework, and Anticipated Impact
Precision dosing, individualized drug treatment regimens based on patient factors, is crucial for improving public health and reducing healthcare costs.
Rigorous JournalInforming the dosing of interventions in randomized trials.
Standardized terminology and reporting of dosing information can improve intervention development, refinement, and systematic reviews, enhancing the identification of optimal doses and efficient implementation in clinical practice.
Systematic ReviewPrecision Dosing: An Industry Perspective
Drug developers must adapt to precision dosing to meet evolving patient, prescriber, and payer expectations, while maintaining efficacy and safety.
Rigorous JournalPrecision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables
Prioritizing precision dosing targets for drugs and diseases based on information quality, proof, and cost-effectiveness can improve patient care and outcomes.
Literature Review
Highly CitedModel-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy.
Model-informed precision dosing (MIPD) is a promising approach for individualizing drug therapy, considering patient characteristics and addressing current debates on its implementation, validation, and implementation in healthcare.
Literature ReviewHighly CitedDosing practices made mundane: Enacting HIV pre-exposure prophylaxis adherence in domestic routines.
Pre-exposure prophylaxis (PrEP) adherence in everyday life is a complex process involving coordination among bodies, routines, desires, material objects, and the home environment, with adaptations to suit life circumstances and manage side effects.
Observational Study