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Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue.

作者信息

Hussain Ajaz S, Morris Kenneth, Gurvich Vadim J

机构信息

The National Institute for Pharmaceutical Technology and Education (NIPTE), Inc., Minneapolis, Minnesota, 55414, USA.

Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn Campus, Brooklyn, New York, 11201, USA.

出版信息

AAPS PharmSciTech. 2021 Mar 4;22(3):88. doi: 10.1208/s12249-021-01970-7.

DOI:10.1208/s12249-021-01970-7
PMID:33665776
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7931785/
Abstract
摘要

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本文引用的文献

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Similarity of dissolution profiles from biorelevant media: Assessment of interday repeatability, interanalyst repeatability, and interlaboratory reproducibility using ibuprofen and ketoconazole tablets.生物相关介质中溶出曲线的相似性：使用布洛芬和酮康唑片剂评估日间重复性、分析人员间重复性和实验室间再现性
Eur J Pharm Sci. 2021 Jan 1;156:105573. doi: 10.1016/j.ejps.2020.105573. Epub 2020 Sep 25.
2
Development and Validation of Sample Preparation and an HPLC Analytical Method for Dissolution Testing in Fed-State Simulated Gastric Fluid-Illustrating Its Application for Ibuprofen and Ketoconazole Immediate Release Tablets.在进食状态模拟胃液中进行溶出试验的样品制备和 HPLC 分析方法的开发和验证——以布洛芬和酮康唑普通片为例。
AAPS PharmSciTech. 2020 Jun 12;21(5):172. doi: 10.1208/s12249-020-01702-3.
3
In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs.新冠疫情期间和之后：美国学术制药科学与工程界必须参与，以满足国家关键需求。
AAPS PharmSciTech. 2020 May 24;21(5):153. doi: 10.1208/s12249-020-01718-9.
4
Determination of Rate and Extent of Scopolamine Release from Transderm Scōp® Transdermal Drug Delivery Systems in Healthy Human Adults.测定健康成年人体内 Transderm Scōp® 透皮药物传递系统中莨菪碱的释放速度和释放程度。
AAPS PharmSciTech. 2020 Apr 16;21(3):117. doi: 10.1208/s12249-020-01658-4.
5
Decision Support for Excipient Risk Assessment in Pharmaceutical Manufacturing.药物制造中辅料风险评估的决策支持。
AAPS PharmSciTech. 2019 Jun 18;20(6):223. doi: 10.1208/s12249-019-1440-x.
6
Predictive and Accelerated Formulation Design Using Synchrotron Methods.基于同步辐射方法的预测和加速制剂设计。
AAPS PharmSciTech. 2019 Apr 29;20(5):176. doi: 10.1208/s12249-019-1375-2.
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Lesson Learnt from Recall of Valsartan and Other Angiotensin II Receptor Blocker Drugs Containing NDMA and NDEA Impurities.从缬沙坦和其他含有 NDMA 和 NDEA 杂质的血管紧张素 II 受体阻滞剂药物召回中吸取的教训。
AAPS PharmSciTech. 2019 Apr 15;20(5):166. doi: 10.1208/s12249-019-1376-1.
8
Feedforward and Feedback Control of a Pharmaceutical Coating Process.药品包衣过程的前馈和反馈控制。
AAPS PharmSciTech. 2019 Apr 1;20(4):157. doi: 10.1208/s12249-019-1348-5.
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Pharmaceutical "New Prior Knowledge": Twenty-First Century Assurance of Therapeutic Equivalence.药品“新先知识”：二十一世纪治疗等效性的保证。
AAPS PharmSciTech. 2019 Mar 12;20(3):140. doi: 10.1208/s12249-019-1347-6.
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Pediatric Formulations: Knowledge Gaps Limiting the Expedited Preclinical to Clinical Translation in Children.儿科制剂：知识空白限制了儿童加速从临床前到临床的转化。
AAPS PharmSciTech. 2019 Jan 10;20(2):73. doi: 10.1208/s12249-018-1253-3.