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GB/T 45138-2024: Technical specification for evaluation of antiviral activity of interferon
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Technical specification for evaluation of antiviral activity of interferon
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GB/T 45138-2024
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Basic data | Standard ID | GB/T 45138-2024 (GB/T45138-2024) | | Description (Translated English) | Technical specification for evaluation of antiviral activity of interferon | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A40 | | Classification of International Standard | 07.800 | | Word Count Estimation | 10,197 | | Date of Issue | 2024-12-31 | | Date of Implementation | 2024-12-31 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 45138-2024: Technical specification for evaluation of antiviral activity of interferon---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical specification for evaluation of antiviral activity of interferon
Technical Specifications for Evaluation of Interferon Antiviral Activity
ICS 07.800
CCS A 40
National Standard of the People's Republic of China
Released on 2024-12-31
2024-12-31 implementation
State Administration for Market Regulation
The National Standardization Administration issued
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting is required.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the China National Institute of Standardization.
This document was drafted by. China National Institute of Standardization, China Food and Drug Inspection Institute, Shanxi Jinbo Biopharmaceutical Co., Ltd.
Department of Medicine, Beijing Tongren Hospital, Capital Medical University.
The main drafters of this document are. Zhao Lin, Shi Xinchang, Pei Dening, Yun Zhenyu, Wang Jian, Wu Qi, Wu Xi, Sun Dandan, Li Ling,
Li Wenjun and Zhang Mengyan.
Technical Specifications for Evaluation of Interferon Antiviral Activity
1 Scope
This document specifies the basic requirements for the evaluation of interferon antiviral activity, the requirements for cells and viruses, and the requirements for personnel training.
Selection of measurement methods, evaluation models, result recording and effectiveness determination.
This document is applicable to the evaluation of the antiviral activity of interferon samples other than pharmaceuticals.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies.
in this document.
GB 19489 General requirements for laboratory biosafety
GB 41918-2022 Biological Safety Cabinet
YY/T 1539 Medical clean bench
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Interferon interferon; IFN
A class of broad-spectrum antiviral proteins that inhibit the spread of viruses by interacting with cell surface receptors to induce cells to produce antiviral proteins.
proliferation.
3.2
Activity
Biological activity
The nature of the antiviral effects of interferon-activated cells.
3.3
dose-effect curve
A curve used to represent the relationship between the concentration/content of the test article and its biological effect.
Note. The horizontal axis is the test sample concentration/content or dilution, and the vertical axis is the biological effect intensity.
3.4
four-parameter equation
A mathematical model with four parameters (A, B, C, and D) that describes the relationship between the dependent variable (y) and the independent variable (x) and is used to present
An expression for the relationship between each test concentration of the test article and its corresponding biological effect.
4 Basic requirements for evaluation
4.1 The laboratory’s biosafety management should comply with the relevant requirements in GB 19489.
4.2 The evaluators should have corresponding test operation capabilities, skill certificates or work experience.
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