Drug dosing guidelines
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Drug Dosing Guidelines: Current Challenges and Approaches
Gaps in Drug Dosing Recommendations for Diverse Patient Populations
Most drug labels lack dosing recommendations for many real-world patients, especially those who are very young or old, pregnant, obese, or have multiple health conditions. This is because clinical trials often exclude these groups, leaving physicians to estimate appropriate doses. There is a growing call to expand current practices by integrating real-world data, predictive models, and harmonized global regulatory policies to provide safer and more effective dosing for all patients 1.
Regulatory Guidance and Model-Informed Precision Dosing
Regulatory agencies like the FDA are shifting focus from simply finding the maximum tolerated dose to identifying the optimal dose for investigational drugs. This involves improved data collection, trial design, and safety monitoring to ensure dosing is both effective and safe for future indications 2. For specific drugs like vancomycin, model-informed precision dosing (MIPD) and therapeutic drug monitoring (TDM) are recommended to balance treatment response and minimize adverse effects, using area under the curve (AUC)-guided dosing and Bayesian estimation methods 5.
Special Populations: Pediatrics, Renal, and Liver Impairment
Pediatric Dosing Guidelines
Pediatric drug dosing is particularly challenging, with about half of drugs prescribed off-label. There is significant variation in dosing recommendations across different national and international guidelines, especially for antibiotics. This inconsistency is often due to unclear evidence or historical preferences rather than robust clinical data. There is a need for harmonized, evidence-based dosing guidelines, possibly supported by physiologically-based pharmacokinetic (PBPK) modeling and international collaboration 710. Studies also show frequent deviations from national dosing guidelines in emergency pediatric care, often resulting in underdosing, highlighting the need for better education and quality improvement 9.
Renal Impairment
Renal failure significantly affects drug pharmacology, requiring careful dose adjustments. Guidelines recommend considering factors like the type of renal replacement therapy, drug clearance, and protein binding. Drug monitoring is especially important for drugs with a narrow therapeutic index, and slight overdosing may be preferred for nontoxic antimicrobials to ensure efficacy 48.
Liver Cirrhosis
Patients with liver cirrhosis also require dose adjustments for drugs metabolized by the liver. However, current recommendations are often inconsistent or insufficiently specific, making clinical decision-making difficult. There is an urgent need for standardized parameters and harmonized dose recommendations for this population 6.
Disease-Specific Dosing: Tuberculosis
For tuberculosis (TB), consensus-based clinical standards have been developed to guide optimal dosing and management. These standards address initial dosing, identifying patients at risk of suboptimal exposure or toxicity, the use of therapeutic drug monitoring, and the importance of education for both patients and healthcare professionals 3.
Conclusion
Drug dosing guidelines are evolving to address the needs of diverse patient populations. There is a clear need for more inclusive, evidence-based, and harmonized recommendations, supported by real-world data, predictive modeling, and international collaboration. Special attention is required for vulnerable groups such as children, patients with renal or liver impairment, and those with specific diseases like TB, to ensure safe and effective drug therapy 12345678+2 MORE.
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