Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates.

Bloomfield D; Krishna R

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Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates.

机译：对新药候选者浓度/ QTc关系的临床相关性的评论。

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The ICH E14 guidance outlines a rigorous assessment on the potential for a drug to prolong ventricular repolarization in a "thorough QT/QTc study" that includes the use of a positive control, characterization of the QT/QTc response at a supratherapeu-tic dose, and methods for reducing variability in the measurement of the QTcf interval (replicate ECGs, use of a centralized core laboratory to measure QTcf interval, etc).

机译：ICH E14指南概述了在“全面的QT / QTc研究”中药物延长心室复极化的潜力的严格评估，其中包括使用阳性对照，表征超治疗剂量下的QT / QTc反应，以及减少QTcf间隔测量的可变性的方法（重复ECG，使用中央核心实验室测量QTcf间隔等）。

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《The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology》 |2008年第1期|共3页
作者
Bloomfield D; Krishna R;
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正文语种 eng
中图分类药理学;
关键词
Cardiovascular Agents; Dose-Response Relationship; Drug; Drugs; Investigational; 心血管药物; 剂量效应关系; 药物; 药物; 临床试用; QT延长综合征; 危险性评估;

机译：Cardiovascular Agents;Dose-Response Relationship;Drug;Drugs;Investigational;心血管药物;剂量效应关系;药物;药物;临床试用;QT延长综合征;危险性评估;

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专利

1. Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates. [J] . Daniel Bloomfield, Rajesh Krishna The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology . 2008,第10期

机译：对新药候选者浓度/ QTc关系的临床相关性的评论。
2. Evaluation of computational platforms, model structures, and 90% confidence interval (CI) estimation methods in the linear mixed-effects modeling of drug concentration vs. change-from-baseline QTc (C-Delta QTc) relationships [J] . Lu Jingtao, Al-Huniti Nidal, Masson Eric, Journal of pharmacokinetics and pharmacodynamics . 2017,第Suppla期

机译：评估药物浓度的线性混合效应建模中的计算平台，模型结构和90％置信区间（CI）估计方法与基线QTC（C-Delta QTC）关系的影响。
3. Thorough QT/QTc in a Dish: An In Vitro Human Model That Accurately Predicts Clinical Concentration-QTc Relationships [J] . Blanchette Alexander D., Grimm Fabian A., Dalaijamts Chimedullam, Clinical Pharmacology and Therapeutics . 2019,第5期

机译：彻底Qt / QTC在一道菜中：一个体外人体模型，可准确预测临床浓度 - QTC关系
4. Pharmacodynamics of Latest Generation H_1.Antihistamines: Relevance of Drug Concentrations at Receptor Sites and of Affinity Values for H_1 Receptors [C] . M. Strolin Benedetti, M. Gillard, N. Frossard, Collegium Internationale Allergologicum . 2007

机译：最新一代H_1的药效学.AntiHistamines：H_1受体的受体位点和亲和力值的相关性的相关性
5. Amiodarone toxicity: Relationships to cumulative dose and serum drug concentrations with preliminary observations of changes in superoxide dismutase activity. [D] . Pollak, Paul Timothy. 1988

机译：胺碘酮毒性：与累积剂量和血清药物浓度的关系，以及超氧化物歧化酶活性变化的初步观察。
6. Clinically Relevant Interpretation of Genotype and Relationship to Plasma Drug Concentrations for Resistance to Saquinavir-Ritonavir in Human Immunodeficiency Virus Type 1 Protease Inhibitor-Experienced Patients [O] . Anne-Geneviève Marcelin, Cécile Dalban, Gilles Peytavin, 2004

机译：对人类免疫缺陷病毒1型蛋白酶抑制剂经验丰富的患者抗Saquinavir-Ritonavir基因型的临床相关解释及其与血浆药物浓度的关系
7. CORRIGENDUM: Thorough QT/QTc in a Dish: An In Vitro Human Model That Accurately Predicts Clinical Concentration‐QTc Relationships [O] . 2019

机译：逆变：彻底QT / QTC在一道菜中：一种精确预测临床浓度 - QTC关系的体外人体模型

Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates.

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