Dosage Adjustments Related to Young or Old Age and Organ Impairment

Burris, James F.; Tortorici, Michael A.; Mandić, Maja; Neely, Michael; Reed, Michael D.

doi:10.1002/jcph.816

Cited by 10 publications

(9 citation statements)

References 34 publications

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“…For example, the covariate model should be based on large cohorts with sufficient patient heterogeneity and enough sampling, have extensive internal and external validation, and be extrapolated to models from similar clinical populations . Last, population PK/PD modeling can also be used as a basis for Bayesian forecasting, whereby prior population PK/PD data can be updated with individual patient data to optimize dosing, particularly for drugs with complex disposition . For example, a population PK model was developed to characterize the PK of mycophenolic acid in children with systemic lupus, accounting for enterohepatic recirculation .…”

Section: Modeling and Simulationmentioning

confidence: 99%

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Balevic

Cohen‐Wolkowiez

2018

The Journal of Clinical Pharma

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Almost half of recent pediatric trials failed to achieve labeling indications, due in large part to inadequate study design. Therefore, innovative study methods are crucial to optimize trial design while also reducing the potential harms inherent with drug investigation. Several methods exist to optimize the amount of pharmacokinetic (PK) data collected from the smallest possible volume and with the fewest number of procedures, including the use of opportunistic and sparse sampling, alternative and non-invasive matrices, and micro-volume assays. In addition, large research networks using master protocols promote collaboration, reduce regulatory burden, and increase trial efficiency for both early- and late-phase trials. Large pragmatic trials that leverage electronic health records can capitalize on central management strategies to reduce costs, enroll patients with rare diseases on a large scale, and augment study generalizability. Further, trial efficiency and safety can be optimized through Bayesian adaptive techniques that permit planned protocol changes based on analyses of prior and accumulated data. In addition to these trial design features, advances in modeling and simulation have paved the way for systems-based and physiologically-based models that individualize pediatric dosing recommendations and support drug approval. Lastly, given the low prevalence of many pediatric diseases, collecting de-identified genetic and clinical data on a large scale is a potentially transformative way to augment clinical pharmacology research in children.

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Section: Modeling and Simulationmentioning

confidence: 99%

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Balevic

Cohen‐Wolkowiez

2018

The Journal of Clinical Pharma

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“…Older persons are more prone to drug-induced renal impairment, because of the age-associated deterioration in kidney function [11][12][13]. In this study, only one in every hundred participants used drugs associated with a moderately and highly increased risk of nephrotoxicity.…”

Section: Discussionmentioning

confidence: 85%

“…Due to these changes in kidney function, aging kidneys are more prone to drug-induced impairments in renal properties [11][12][13]. There are reports that a number, from 6% [14] to 19% [15], of community-acquired acute kidney injuries (AKIs) were caused by nephrotoxic drugs.…”

Section: Introductionmentioning

confidence: 99%

“…There are reports that a number, from 6% [14] to 19% [15], of community-acquired acute kidney injuries (AKIs) were caused by nephrotoxic drugs. There are changes in the pharmacokinetics of several drugs as a result of the altered kidney function and therefore kidney function measurements are strongly recommended when prescribing medications to older persons [11][12][13]16].…”

Section: Introductionmentioning

confidence: 99%

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Kidney function and nephrotoxic drug use among older home-dwelling persons with or without diabetes in Finland

et al. 2020

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Background: Due to these changes in kidney function, aging kidneys are more prone to drug-induced impairments in renal properties. Diabetes has been associated with the declined kidney function and an elevated risk of renal failure. The aim of this study is to compare kidney function and potentially nephrotoxic drug use among home-dwelling older persons with or without diabetes. Methods: A total of 259 persons with and 259 persons without diabetes and aged ≥65 years were randomly selected to participate in a health examination with complete data gathered from 363 individuals (187 with diabetes and 176 without diabetes). The estimated glomerular filtration rate (eGFR) was calculated using CKD-EPI equation. Each participant was categorized based on the nephrotoxic profile of their medications. Results: There were no differences in mean eGFR values (77.5 ± 18.8 vs. 80.5 ± 14.8 ml/min/1.73m 2 , p = 0.089) or in the proportion of participants with eGFR < 60 ml/min/1.73m 2 among persons with diabetes (16% vs. 10%, p = 0.070), compared to persons without diabetes. Potentially nephrotoxic drug use was similar between the groups. The mean number of potentially nephrotoxic drugs was 1.06 ± 0.88 in those with and 0.97 ± 1.05 in those without diabetes (p = 0.39). Conclusions: The kidney function of older persons with diabetes does not differ from that of older persons without diabetes and furthermore potentially nephrotoxic drug use seem to play only a minor role in the decline in kidney function among home-dwelling persons in the Inner-Savo district.

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“…The American College of Clinical Pharmacology is providing a set of standards representing the EPAs in clinical pharmacology, which are published as a series of papers in the Journal of Clinical Pharmacology under the educational banner "Pearls for Clinical Practice." We have identified the following core topics that every prescribing clinician needs to master: 1 (1) basic pharmacokinetics and pharmacodynamics; 2 (2) dosage adjustment for organ impairment and age; 3 (3) drug-drug interactions; (4) biologics; (5) adherence; 4 (6) identifying, understanding, and interpreting drug information sources; (7) summarizing common problem drugs; and (8) how to work within the health care-providing team. Each topic contains a succinct analytical review of key concepts and is accompanied by several memorable realworld vignettes, followed by a discussion, including a well-reasoned solution.…”

mentioning

confidence: 99%

Core Entrustable Professional Activities in Clinical Pharmacology for Entering Residency: Biologics

Donnenberg

Mandić

Rhee

et al. 2017

The Journal of Clinical Pharma

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Dosage Adjustments Related to Young or Old Age and Organ Impairment

Cited by 10 publications

References 34 publications

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Kidney function and nephrotoxic drug use among older home-dwelling persons with or without diabetes in Finland

Core Entrustable Professional Activities in Clinical Pharmacology for Entering Residency: Biologics

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