Population pharmacokinetic (PPK) modeling and simulation‐derived dosing of intravenous busulfan (Busulfex) in pediatric patients

Booth, Brian; Rahman, A. F. A.; Dagher, Ramzi; Griebel, Donna; Lai, A. A.; Lennon, Shari; Fuller, David E.; Gobburu, Joga

doi:10.1016/s0009-9236(03)90602-3

Cited by 2 publications

(2 citation statements)

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“…Indeed, renal clearance of the drugs correlates closely with creatinine clearance, as has been demonstrated for different BPs in different patient populations (Figure ). Indeed, renal clearance was an essential part of the PK model for zoledronic acid on which the US Food and Drug Administration (FDA) based their dose recommendations for patients with renal impairment . None of the FDA‐approved BPs have been approved for use in patients with a creatinine clearance below 35 mL/min, which precludes use in patients with severe renal impairment who may benefit from anti‐resorptive treatment when found to have (bone biopsy‐proven) high bone turnover bone loss due to secondary hyperparathyroidism.…”

Section: Pharmacokineticsmentioning

confidence: 99%

Pharmacology of bisphosphonates

Cremers

Drake

Ebetino

et al. 2019

Brit J Clinical Pharma

174

107

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The biological effects of the bisphosphonates (BPs) as inhibitors of calcification and bone resorption were first described in the late 1960s. In the 50 years that have elapsed since then, the BPs have become the leading drugs for the treatment of skeletal disorders characterized by increased bone resorption, including Paget's disease of bone, bone metastases, multiple myeloma, osteoporosis and several childhood inherited disorders. The discovery and development of the BPs as a major class of drugs for the treatment of bone diseases is a paradigm for the successful journey from "bench to bedside and back again". Several of the leading BPs achieved "blockbuster" status as branded drugs. However, these BPs have now come to the end of their patent life, making them highly affordable. The opportunity for new clinical applications for BPs also exists in other areas of medicine such as ageing, cardiovascular disease and radiation protection. Their use as inexpensive generic medicines is therefore likely to continue for many years to come. Fifty years of research into the pharmacology of bisphosphonates have led to a fairly good understanding about how these drugs work and how they can be used safely in patients with metabolic bone diseases. However, while we seemingly know much about these drugs, a number of key aspects related to BP distribution and action remain incompletely understood. This review summarizes the existing knowledge of the (pre)clinical and translational pharmacology of BPs, and highlights areas in which understanding is lacking.

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Section: Pharmacokineticsmentioning

confidence: 99%

Pharmacology of bisphosphonates

Cremers

Drake

Ebetino

et al. 2019

Brit J Clinical Pharma

174

107

View full text Add to dashboard Cite

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“…Modern technology has presented promising solutions to the challenges described above, chief among them, model-informed precision dosing (MIPD). Model-based methods that rely on sophisticated pharmacostatistical analyses have been used for decades by pharmaceutical companies and regulatory agencies to derive rational individualized dosing guidelines ( Booth et al, 2003 ; Madabushi et al, 2011 ; Florian et al, 2013 ; Lala et al, 2013 ; Pereira et al, 2022 ). Historically, the tools and personnel needed to perform such analyses have been unavailable in the acute care setting.…”

Section: Generating Evidence-based Individualized Dosing Regimensmentioning

confidence: 99%

Bayesian model-guided antimicrobial therapy in pediatrics

Bunn,

Gobburu,

Floryance

2023

Front. Pharmacol.

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Antimicrobials have transformed the practice of medicine, making life-threatening infections treatable, but determining optimal dosing, particularly in pediatric patients, remains a challenge. The lack of pediatric data can largely be traced back to pharmaceutical companies, which, until recently, were not required to perform clinical testing in pediatrics. As a result, most antimicrobial use in pediatrics is off-label. In recent years, a concerted effort (e.g., Pediatric Research Equality Act) has been made to fill these knowledge gaps, but progress is slow and better strategies are needed. Model-based techniques have been used by pharmaceutical companies and regulatory agencies for decades to derive rational individualized dosing guidelines. Historically, these techniques have been unavailable in a clinical setting, but the advent of Bayesian-model-driven, integrated clinical decision support platforms has made model-informed precision dosing more accessible. Unfortunately, the rollout of these systems remains slow despite their increasingly well documented contributions to patient-centered care. The primary goals of this work are to 1) provide a succinct, easy-to-follow description of the challenges associated with designing and implementing dose-optimization strategies; and 2) provide supporting evidence that Bayesian-model informed precision dosing can meet those challenges. There are numerous stakeholders in a hospital setting, and our intention is for this work to serve as a starting point for clinicians who recognize that these techniques are the future of modern pharmacotherapy and wish to become champions of that movement.

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Population pharmacokinetic (PPK) modeling and simulation‐derived dosing of intravenous busulfan (Busulfex) in pediatric patients

Abstract: Clinical Pharmacology & Therapeutics (2003) 73, P66–P66; doi:

Cited by 2 publications

References 0 publications

Pharmacology of bisphosphonates

Pharmacology of bisphosphonates

Bayesian model-guided antimicrobial therapy in pediatrics

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