相关实验视频
Updated: Jan 13, 2026

11:18
Direct Drug Delivery to Kidney via the Renal Artery
Published on: April 17, 2021
8.1K
对当前行业实践的分析,以告知功能障碍患者的剂量建议
Noah Christopher Frazier1, Islam Younis2, Ashish Sharma1
1Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Clinical and translational science
|January 7, 2026
概括
制药行业 制药行业 是一个制药行业.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
- 临床指南 临床指南
背景情况:
- 临床指南旨在标准化功能评估,但行业采用情况尚不清楚.
- 评估功能障碍对药物暴露的影响对于患者剂量至关重要.
- 对于治疗功能障碍的药物开发的当前行业实践需要审查.
研究的目的:
- 描述目前评估功能障碍对药物暴露的影响的方法.
- 为了为患有功能障碍的患者提供剂量建议.
- 提供对制药行业实践的洞察力,并确定改进领域.
主要方法:
- 审查了FDA (2018-2024) 批准的192种新分子实体 (NME).
- 分析了临床开发策略,以评估功能障碍对药理动力学和安全性的影响.
- 专门研究中用于功能评估的检查方法 (eGFR,测量GFR,肌素清除率).
主要成果:
- 估计的淋巴球过率 (eGFR) 在60项研究中使用;31项研究中使用肌素清除率.
- 对于轻度功能障碍的6个NME,需要采取行动的剂量建议.
- 对于严重功能障碍的47个NME,需要采取行动的剂量建议.
结论:
- 不需要将患有轻度功能障碍的患者排除在2期和3期研究之外.
- 行业必须加强药物开发与现有临床指南的协调.
- 需要继续努力,以标准化功能障碍药物开发实践.
相关概念视频
Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant
205
In patients with renal disease, dosage adjustments are necessary to maintain therapeutic plasma drug concentrations and prevent toxicity or subtherapeutic exposure. Renal impairment alters drug pharmacokinetics, especially in conditions like uremia, where changes such as prolonged elimination half-life and altered apparent volume of distribution can significantly affect drug disposition. These changes require careful modification of the dosing regimen to achieve the desired clinical...
205
Renal Failure: Dose Adjustments
429
In patients with renal impairment, drugs undergo significant changes in their pharmacokinetics, which require dosage adjustments to ensure safe and effective therapy.
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
429
Dosage Regimens: Designs and Approaches
258
Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
258
Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration
185
Glomerular filtration rate (GFR) can be estimated from serum creatinine using the modification of diet in renal disease (MDRD) formula or the chronic kidney disease–epidemiology collaboration (CKD–EPI) equation. Both methods are widely used in clinical practice to assess kidney function and guide treatment decisions.The MDRD equation does not require weight or height measurements and is normalized to the body surface area of 1.73 m², considered the average adult surface area.
185
Dosage Regimen Designs: Nomograms and Tabulations
174
Nomograms and tabulations are vital tools used by clinicians to design accurate and individualized dosage regimens. These instruments provide a straightforward method for adjusting dosages based on individual patient characteristics, including age, weight, and physiological condition. The foundation of a drug's nomogram is population pharmacokinetic data collected and analyzed using specific models. This data simplifies complex equations, presenting them diagrammatically or tabularly for easy...
174
Dosage Regimen: Individualization
165
Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
165

