生物技术产品的质量：生物技术/生物制品的稳定性试验。国际人用药品注册技术协调会《新药原料药和制剂稳定性试验指导原则》三方协调指南附件 - Suppr

Suppr

超能文献

Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.

出版信息

Dev Biol Stand. 1998;93:211-9.

PMID:9737398

Abstract

摘要

相似文献

Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.生物技术产品的质量：生物技术/生物制品的稳定性试验。国际人用药品注册技术协调会《新药原料药和制剂稳定性试验指导原则》三方协调指南附件

Dev Biol Stand. 1998;93:211-9.

Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products. ICH Harmonised Tripartite Guideline.生物技术产品质量：用于生产重组DNA衍生蛋白产品的细胞系中表达构建体的分析。国际人用药品注册技术协调会三方协调指导原则

Dev Biol Stand. 1998;93:205-8.

Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. ICH Harmonised Tripartite Guideline.生物技术产品质量：用于生产生物技术/生物制品的细胞基质的来源与特性。国际协调会议三方协调指南。

Dev Biol Stand. 1998;93:223-34.

Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline.生物技术产品的质量：源自人或动物细胞系的生物技术产品的病毒安全性评估。国际协调会议三方协调指南。

Dev Biol Stand. 1998;93:177-201.

Stability testing requirements for vaccines--draft guidelines of the International Conference on Harmonization.疫苗稳定性测试要求——国际协调会议草案指南

Dev Biol Stand. 1996;87:309-18.

The quality control of biotechnology products.

Biologicals. 1994 Jun;22(2):151-9. doi: 10.1006/biol.1994.1021.

International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS.国际协调会议；生物技术/生物制品质量指南：用于生产生物技术/生物制品的细胞基质的来源与特性；可获取性。通知。美国卫生与公众服务部食品药品监督管理局

Fed Regist. 1998 Sep 21;63(182):50244-9.

International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice.国际协调会议；关于源自人或动物细胞系的生物技术产品病毒安全性评估的指南；可获取性——美国食品药品监督管理局。通知。

Fed Regist. 1998 Sep 24;63(185):51074-84.

International Conference on Harmonisation; guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products. Notice. Food and Drug Administration, HHS.国际协调会议；生物技术/生物制品的规格、测试程序及验收标准指南。通知。美国卫生与公众服务部食品药品监督管理局

Fed Regist. 1999 Aug 18;64(159):44928-35.

Current practices in endotoxin and pyrogen testing in biotechnology. The Quality Assurance/Quality Control Task Group. Parenteral Drug Association.生物技术中内毒素和热原检测的现行做法。质量保证/质量控制任务组。胃肠外药物协会。

J Parenter Sci Technol. 1990 Jan-Feb;44(1):39-45.

引用本文的文献

Current challenges and future directions of ATMPs in regenerative medicine.再生医学中先进治疗医药产品的当前挑战与未来方向

Regen Ther. 2025 Jul 9;30:358-370. doi: 10.1016/j.reth.2025.06.017. eCollection 2025 Dec.

Quality by Design Based Chromatography Technique Development and Validation for the Medicine Venetoclax (for Chronic Leukemia), in the Context of Impurities Including Degradation Products.基于质量源于设计的色谱技术开发与验证，用于药物维奈克拉（治疗慢性白血病），涉及包括降解产物在内的杂质情况

Biomed Chromatogr. 2025 May;39(5):e70072. doi: 10.1002/bmc.70072.

Study of the Effect of Phosvitin as a Potential Carrier on the Permeation Process of Somatotropin (STH) and Corticotropin (ACTH) from Biodegradable Polymers Used as Vehicles for STH and ACTH in Semi-Solid Formulations for Skin Application.以磷酸化卵黄高磷蛋白作为潜在载体对生长激素（STH）和促肾上腺皮质激素（ACTH）从用作皮肤半固体制剂中STH和ACTH载体的可生物降解聚合物中的渗透过程影响的研究。

Polymers (Basel). 2024 Sep 18;16(18):2640. doi: 10.3390/polym16182640.

Novel inhaled andrographolide for treatment of lung cancer: o assessment.新型吸入性穿心莲内酯治疗肺癌的评估

Heliyon. 2024 May 4;10(9):e30761. doi: 10.1016/j.heliyon.2024.e30761. eCollection 2024 May 15.

Development of a formulation of potassium iodide tablets as an antidote against nuclear incidents.开发碘化钾片剂配方作为应对核事故的解毒剂。

Saudi Pharm J. 2023 Nov;31(11):101814. doi: 10.1016/j.jsps.2023.101814. Epub 2023 Oct 5.

Hydrogel Formulations for Topical Insulin Application: Preparation, Characterization and In Vitro Permeation across the Strat-M Membrane.用于局部应用胰岛素的水凝胶制剂：制备、表征及体外透过Strat-M膜的研究

Polymers (Basel). 2023 Sep 4;15(17):3639. doi: 10.3390/polym15173639.

Development and Validation of SI/RS-UHPLC-PDA Method for Olmesartan Medoxomil and Metoprolol Succinate-Related Substance.奥美沙坦酯和琥珀酸美托洛尔相关物质的SI/RS-UHPLC-PDA方法的开发与验证

Turk J Pharm Sci. 2023 Mar 2;20(1):39-47. doi: 10.4274/tjps.galenos.2022.57384.

Steps toward nebulization in-use studies to understand the stability of new biological entities.迈向喷雾使用研究以了解新型生物制剂稳定性的步骤。

Drug Discov Today. 2023 Feb;28(2):103461. doi: 10.1016/j.drudis.2022.103461. Epub 2022 Nov 28.

Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of -Resveratrol and -Resveratrol in an Injectable Solution.一种用于同时测定注射剂溶液中白藜芦醇和白藜芦醇的稳定性指示高效液相色谱法的开发与验证

J Anal Methods Chem. 2021 Nov 13;2021:8402157. doi: 10.1155/2021/8402157. eCollection 2021.

Pre-Formulation Studies: Physicochemical Characteristics and In Vitro Release Kinetics of Insulin from Selected Hydrogels.处方前研究：选定水凝胶中胰岛素的物理化学特性及体外释放动力学

Pharmaceutics. 2021 Aug 6;13(8):1215. doi: 10.3390/pharmaceutics13081215.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验