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Profiles of drug substances, excipients, and related methodology最新文献

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Vandetanib. 咒骂。
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2023-01-01 DOI: 10.1016/bs.podrm.2022.11.004
Ahmed I Al-Ghusn, Ahmed H Bakheit, Mohamed W Attwa, Haitham AlRabiah

Vandetanib is an anti-cancer drug called an antineoplastic kinase inhibitor. The FDA authorized vandetanib on April6, 2011 for the treatment of nonresectable, locally progressed, or metastatic medullary thyroid carcinoma in adults. Because Vandetanib can make the Q-T interval last longer, it shouldn't be given to people with serious heart problems like congenital long QT syndrome or heart failure that hasn't been fixed yet. This chapter provides an overview of Vandetanib's physical and molecular properties, mode of action, pharmacokinetics, and common applications. In furthermore, a detailed summary of the reported techniques of Vandetanib measurement will be provided to assist analysts in selecting the most practical approach for its estimation in routine analysis. This chapter will also explain the synthesis methods developed in the preparation of vandetanib as well as pharmacology of its. In addition, this section summarizes the analytical and characterization techniques utilized to characterize vandetanib row material.

万德替尼是一种抗癌药物，被称为抗肿瘤激酶抑制剂。FDA于2011年4月6日批准vandetanib用于成人不可切除、局部进展或转移性甲状腺髓样癌的治疗。因为Vandetanib可以延长Q-T间期，它不应该给那些有严重心脏问题的人，比如先天性长QT综合征或心脏衰竭，这些问题还没有得到解决。本章概述了Vandetanib的物理和分子特性、作用方式、药代动力学和常见应用。此外，将提供Vandetanib测量报告技术的详细总结，以帮助分析人员在常规分析中选择最实用的方法进行估计。本章还将介绍万德替尼的合成方法及其药理作用。此外，本节总结了用于表征vandetanib材料的分析和表征技术。
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引用次数: 2
Application of chemometrics using direct spectroscopic methods as a QC tool in pharmaceutical industry and their validation. 化学计量学直接光谱法在制药工业中的应用及其验证。
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2022-01-01 DOI: 10.1016/bs.podrm.2021.10.006
L. Wulandari, R. Idroes, T. R. Noviandy, G. Indrayanto
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引用次数: 8
Loratadine.
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2022-01-01 DOI: 10.1016/bs.podrm.2021.10.002
N. AlMasoud, Ahmed H H Bakheit, M. F. Alshammari, H. Abdel‐Aziz, H. Alrabiah
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引用次数: 0
Lodenafil.
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2022-01-01 DOI: 10.1016/bs.podrm.2021.10.004
Yahya M. Alshehri, Abdulrahman A Al-Majed, Mohamed W. Attwa, Ahmed H H Bakheit
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引用次数: 2
Vinpocetine (A comprehensive profile). 长春西汀(综合概况)。
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2022-01-01 DOI: 10.1016/bs.podrm.2021.10.001
N. Khalil, A. Bakheit, H. Alkahtani, Turki Al-Muhanna
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引用次数: 4
Preface. 前言。
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2022-01-01 DOI: 10.1016/S1871-5125(22)00009-7
Abdulrahman A Al-Majed
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引用次数: 0
Validation of in-vitro bioassay methods: Application in herbal drug research. 体外生物测定方法的验证:在中药研究中的应用。
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2021-01-01 Epub Date: 2020-08-27 DOI: 10.1016/bs.podrm.2020.07.005
Gunawan Indrayanto, Galih Satrio Putra, Farida Suhud

This present review described the validation method of in-vitro bioassay for its application in herbal drug research. Seven sequencing steps that can be taken for performing a valid bioassay include: literature survey, sample stability evaluation, Biosystem performance testing, Sample performance evaluation, determination of 50% effective concentration or cytotoxic concentrations, selective index evaluation, and determination of accurate relative potency of sample. Detailed methods and acceptance criteria for each step are described herein. Method calculations of the relative potency of sample using European Pharmacopeia 10.0, 5.3 (2020) were recommended instead of using United States Pharmacopeia 42 (2019). For having reliable data and conclusions, all methods (chemical and bioassay) need to be first validated before any data collection. Absence of any validation method may results in incorrect conclusions and bias.

本文综述了体外生物测定法在中药研究中的应用。进行有效生物测定可采取的七个测序步骤包括:文献调查、样品稳定性评估、生物系统性能测试、样品性能评估、50%有效浓度或细胞毒性浓度的测定、选择性指标评估和样品准确相对效价的测定。详细的方法和验收标准的每一步都描述在这里。建议使用欧洲药典10.0、5.3(2020)计算样品的相对效价，而不是使用美国药典42(2019)。为了获得可靠的数据和结论，所有方法(化学和生物测定)都需要在收集数据之前首先进行验证。缺乏任何验证方法可能导致不正确的结论和偏差。
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引用次数: 144
Rabeprazole: A comprehensive profile. 雷贝拉唑:综合概况。
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2021-01-01 Epub Date: 2020-08-13 DOI: 10.1016/bs.podrm.2020.07.003
Ahmed H Bakheit, Hamad M Al-Kahtani, Salem Albraiki

Rabeprazole belongs to the class of anti-secretory drugs, with benzimidazoles substitution. These drugs induce gastric acid secretion through precise inhibition of the enzyme H+/K+-ATPase (acid or proton pump). This effect helps to treat and prevent conditions in which gastric acid directly aggravates symptoms such as duodenal and gastric ulcers. This chapter includes a comprehensive review of rabeprazole in terms of nomenclature, its physical-chemical properties, methods of preparation and ADME profiles. In addition, the chapter also includes a review of several methods for analysis of rebeprazole in its dosage forms and biological fluids.

雷贝拉唑属于抗分泌类药物，与苯并咪唑替代。这些药物通过精确抑制H+/K+- atp酶(酸或质子泵)诱导胃酸分泌。这种效果有助于治疗和预防胃酸直接加重十二指肠溃疡和胃溃疡等症状的情况。本章对雷贝拉唑的命名、理化性质、制备方法和ADME概况进行了综述。此外，本章还包括几种方法的分析雷巴拉唑的剂型和生物液体的审查。
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引用次数: 1
Series Page 系列页面
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2021-01-01 DOI: 10.1016/s1871-5125(21)00004-2
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引用次数: 0
Copyright 版权
Q1 Pharmacology, Toxicology and Pharmaceutics
Profiles of drug substances, excipients, and related methodology
Pub Date : 2021-01-01 DOI: 10.1016/s1871-5125(21)00006-6
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引用次数: 0
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