Abstract:
:Glomerular filtration rate (GFR) is routinely used as a surrogate endpoint for the development of investigational drugs in clinical trials. GFR and staging of chronic kidney disease are typically assessed by measuring the concentration of endogenous serum biomarkers such as albumin and creatinine. However, creatinine is subject to high biological variability, and levels of creatinine do not rise until nearly 50% of kidney function is damaged, leading to inaccurate chronic kidney disease staging and false negatives. A newer biomarker for GFR, cystatin C, has been shown to be subject to less biological interference and more sensitive to early declines in kidney function. Cystatin C has also been shown to outperform creatinine as an indicator of true GFR and to add information about the occurrence of acute kidney injury. Comparison studies of cystatin C and creatinine continue to demonstrate its increased accuracy and sensitivity for changes in true GFR. While challenges remain for use of cystatin C, international agencies and working groups continue to validate cystatin C as a biomarker and accompanying GFR estimating equations for diagnostic and drug development use. In this review, we summarize these comparison studies, regulatory and industry guidelines, and clinical trial case studies for use of cystatin C in drug development.
journal_name
J Clin Pharmacoljournal_title
Journal of clinical pharmacologyauthors
Kar S,Paglialunga S,Islam Rdoi
10.1002/jcph.1132subject
Has Abstractpub_date
2018-10-01 00:00:00pages
1239-1247issue
10eissn
0091-2700issn
1552-4604journal_volume
58pub_type
杂志文章,评审abstract::Continuous Holter recordings are often used in thorough QT studies (TQTS), with multiple 10-second electrocardiograms (ECGs) visually selected around predesignated time points. The authors hypothesized that computer-automated ECG selection would reduce within-subject variability, improve study data precision, and incr...
journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1177/0091270011430505
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abstract::Astronauts experience Space Motion Sickness requiring treatment with an anti-motion sickness medication, scopolamine during space missions. Bioavailability after oral administration of scopolamine is low and variable, and absorption form transdermal patch is slow and prolonged. Intranasal administration achieves faste...
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abstract::The approved antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, were considered good candidates for a fixed-dose combination product that could be administered as a single pill once daily (qd), thereby simplifying existing treatment regimens and promoting patient adherence. As both drugs are extens...
journal_title:Journal of clinical pharmacology
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abstract::Rasagiline is an irreversible monoamine oxidase type B (MAO-B) inhibitor indicated for the treatment of the signs and symptoms of idiopathic Parkinson disease as initial monotherapy and as adjunct therapy to levodopa. Pharmacologic inhibition of monoamine oxidase type A (MAO-A), but not MAO-B, poses a risk of the "che...
journal_title:Journal of clinical pharmacology
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journal_title:Journal of clinical pharmacology
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journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 临床试验,杂志文章
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journal_title:Journal of clinical pharmacology
pub_type: 杂志文章
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journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1995-08-01 00:00:00
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journal_title:Journal of clinical pharmacology
pub_type: 杂志文章
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更新日期:2020-01-01 00:00:00
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journal_title:Journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1002/j.1552-4604.1991.tb03663.x
更新日期:1991-10-01 00:00:00
abstract::Cyclosporin G (CSG) has produced less nephrotoxicity than cyclosporin A (CSA) at equivalent doses in animal models. Conflicting results have been reported concerning differences in the pharmacokinetics of CSA and CSG in preclinical studies, and no data exist regarding the effect of steady-state oral administration of ...
journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1002/j.1552-4604.1997.tb04339.x
更新日期:1997-07-01 00:00:00
abstract::In a double-blind, randomized, crossover study in ten patients with asthma, the effects on specific airway resistance of esmolol, a new ultra-short-acting beta 1-selective adrenoceptor blocker, were compared with those of placebo. Specific airway resistance was measured during increasing doses of esmolol infusion, dur...
journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2007-11-01 00:00:00
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journal_title:Journal of clinical pharmacology
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pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 临床试验,杂志文章
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journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章
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更新日期:1975-08-01 00:00:00
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journal_title:Journal of clinical pharmacology
pub_type: 杂志文章
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更新日期:1992-12-01 00:00:00
abstract::The anxiolytic triazolobenzodiazepine alprazolam was administered to six male patients, aged 26 to 46 years, with panic disorder or agoraphobia (with panic attacks) to assess clinical effects and steady-state pharmacokinetics following multiple dosing at three levels: 3.0 mg/d, 6.0 mg/d, and 9.0 mg/d. Multiple-dose ki...
journal_title:Journal of clinical pharmacology
pub_type: 杂志文章
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更新日期:1986-04-01 00:00:00
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journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 杂志文章,随机对照试验
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abstract::Grapefruit is rich in flavonoids, which have been demonstrated to have a preventive influence on many chronic diseases, such as cancer and cardiovascular disease. However, since the early 1990s, the potential health benefits of grapefruit have been overshadowed by the possible risk of interactions between drugs and gr...
journal_title:Journal of clinical pharmacology
pub_type: 杂志文章,评审
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更新日期:2006-12-01 00:00:00
abstract::The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), the German drug regulation authority, issued guidelines for determining whether bioavailability/bioequivalence studies are required for certain drugs. This decision tree is based on pharmacodynamic, pharmacokinetic, and physicochemical criteria. Details ...
journal_title:Journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1002/j.1552-4604.1998.tb04385.x
更新日期:1998-10-01 00:00:00
abstract::The relative analgesic potency of oral and intramuscular oxymorphone was evaluated in a double-blind crossover comparison of graded single doses in patients with chronic pain due to cancer. When both duration and intensity of analgesia are considered (total effect), oral oxymorphone was 1/6 as potent as the intramuscu...
journal_title:Journal of clinical pharmacology
pub_type: 临床试验,杂志文章
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更新日期:1977-04-01 00:00:00
abstract::Anemia is a well-known RBV-related event in HCV therapy which is exacerbated by the addition of telaprevir and boceprevir. This retrospective study evaluated and compared ribavirin exposure and parameters able to influence hemoglobin decrease in a large population of patients treated with dual or triple therapy. Patie...
journal_title:Journal of clinical pharmacology
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更新日期:2015-05-01 00:00:00