湖南翻译公司孙老师指出：生物学翻译是指具有动能的生物，也是一个物体的集合，而个体生物指的是生物体。

 

生物制品质控分析方法的准确性和可靠性与技术方法本身（包括方法的原理和方法的技术特点等）密切相关，所以应首先详述分析方法，包括：

 

（一）、分析方法的原理

阐明分析方法的原理。

（二）、供试品

应说明如何取样，包括每次测定时取样的数量、如何取用（单支或多支混合）等。

（三）、测试用仪器及参数

列出所有测试用仪器及仪器的相关参数。

（四）、测试用试剂

列出所有测试用的试剂和规格，并说明其来源。如果某些试剂为自制或对采购的试剂进行了加工处理，则应详述制备或处理过程。

（五）、标准品或参考品的配备

详述标准品或参考品的来源和配备过程。标准品或参考品的来源应符合国家有关规定。

（六）、供试品的配备

详述待测样品的配备过程

（七）、测试过程

按实验步骤详述整个实验过程，说明关键步骤的实验条件。

（八）、计算

尽可能以表格的形式显示所获取的数据，说明数据的处理方法，提供计算公式，并说明计算方法的出处及采用依据。

（九）、结果报告

说明结果报告的形式

（十）、判定标准

提供判定标准，说明判定标准的制定依据。

The accuracy and the reliability of the quality control analytical methods for biological products are closely related to the technical methods themselves (including theories, technical properties and other aspects of the methods), therefore, the analytical methods should be firstly introduced in detail, including:

(1)  The theory for the analytical method 

The theory for the analytical method should be illustrated. 

(2)  Products for test 

The sampling process should be explained, including the sampling amount during each test, how to carry out the sampling (a single dose or the mixture from multiple doses) and others.

(3)  Instruments for test and corresponding parameters 

All of the instruments for test and corresponding parameters should be listed.  

(4)  Reagents for test 

All of the reagents for test and the specifications should be listed, and the sources should be illustrated. If some reagents are self-made or processing has been carried out on purchased reagents, the process for the preparation or handling should be illustrated in detail. 

(5)  Equipments of standard preparations or reference preparations 

Sources of the standard preparations or the reference preparations as well as the preparation process should be illustrated in detail. The sources of standard preparations or reference preparations should satisfy corresponding national specifications.  

(6)  Preparation of the samples for test 

Preparation of the samples for test should be illustrated in detail. 

(7)  Detection process 

The entire process for the detection should be illustrated in detail according to the experimental procedures, and the experimental conditions of key procedures should be indicated. 

(8)  Calculation 

The obtained data should be displayed in the form of tables as far as possible, the processing method for the data should be indicated, the formula for calculation should be provided, and the sources and the evidences for its utilization should be illustrated. 

(9)  Result report 

The pattern of result report should be illustrated.

(10)  Judging criteria 

The judging criteria should be provided and the basis for the formulation of judging criteria should be illustrated.  

 

 

 

 

文章来源：湖南翻译公司