英语翻译1.INTRODUCTIONThe aim of this validation study has been

英语翻译
1.INTRODUCTION
The aim of this validation study has been to demonstrate that the method AD-TM-R165335-F051-POW-LD-000959-v2 is suitable for determination of the particle size distribution of R165335 – F051 by means of laser diffraction.The following compounds have been used in the validation.
2.METHOD VALIDATION
2.1.Precision
2.1.1.Analysis Repeatability – test results and acceptance
criteria
Analysis repeatability expresses the precision of the analytical method under the same operating conditions over a short interval of time.The repeatability of the method has been determined by the 6-fold analysis of 1 sample of the drug product batch by 1 analyst on 1 day,using 1 instrument.Based on the
volume distribution,for each analysis the dV10,dV50 and dV90 cumulative undersizes are reported.In addition,for each series of particle size data the averages,standard deviations,relative standard deviations (RSD),and 95% confidence intervals are reported.For evaluation purposes,the RSD values are compared with the acceptance criteria.
2.1.2.Intermediate Precision – test results and acceptance
criteria
Intermediate precision expresses the within laboratory variations,e.g.different days,different analysts,etc.For this purpose,the intermediate precision of the method has been determined by 2 analysts,each analysing the product in 6-fold.The analyses have been done using 1 instrument,whereas analyst 1 performed a 6-fold analysis on day 1,and analyst 2 performed a 6-fold analysis on day 2.The validation data as obtained for the
analysis repeatability testing will be used as the analyst 1 data set.Based on the volume distribution,for each analysis the dV10,dV50 and dV90 cumulative undersizes are reported.In addition,for each series of particle size data the averages,standard deviations,relative standard deviations (RSD),and 95% confidence intervals are reported.For evaluation purposes,the RSD values are compared with the acceptance criteria.
Participating Analysts:
• Analyst 1:Global Analytical Development,Method Development,Beers (Belgium)
• Analyst 2:Global Analytical Development,Stability Evaluation and Release,Beers (Belgium)
2.1.3.Conclusions
The particle size method AD-TM-R165335-F051-POW-LD-000959-v2 has
been demonstrated to show an adequate analysis repeatability and
intermediate precision.
2.2.Robustness
The robustness of the analytical method has been tested during the method development and is a measure of its capacity to remain unaffected by small but deliberate variations in method parameters.The capability of method AD-TM-R165335-F051-LD-000959-v2 to remain unaffected has been tested by varying the following parameter:
1.Slid Width (and thereby the mass flow of the product in the instrument)
2.2.1.Conclusions
The robustness of the method has been demonstrated by showing the validity of the method after small deliberate changes to the slid width.

1.前言
有效性研究的目的已经论证了AD-TM-R165335-F051-POW-LD-000959-V2方法对于R165335-F051通过激光衍射的方式进行粒径分布的测定是可行的.
2.方法学验证
2.1 精密度
2.1.1.分析方法重复性---测试结果和验收标准
分析方法的重复性表明了在一小段时间间隔里,在相同的操作条件下分析方法的精密度.方法重复性的测定是通过1个分析人员在1天之内使用1台仪器对相同批次药品中的同一样品的6次分析完成的.基于容积分布,对于每组分析,dv10,dv50和dv90的累积的筛出物已见报道.此外,对于每个系统的粒径数据,平均值,标准偏差和相对标准偏差和95%的置信区间已被报道.RSD值与接受标准进行比较来对其进行评价.
2.1.2.中间精密度---测试结果和验收标准
中间精密度表明的是实验室的随机变动因素,例如日期,不同分析人员等的影响.因此为了这个指标,2组分析人员,每组分析人员对产品进行了6次测定,测定了方法的中间精密度.分析是使用1台仪器完成的,第1组分析人员是在1天内测定的6次实验,而第2组分析人员是在2天内进行的6次实验.分析重复性试验获得的有效性数据使用在了第1组分析人员的数据组里.基于容积分布,对于每组分析,dv10,dv50和dv90的累积的筛出物已见报道.此外,对于每个系统的粒径数据,平均值,标准偏差和相对标准偏差和95%的置信区间已被报道.RSD值与接受标准进行比较来对其进行评价.
参与分析人员：
●分析组1：全球分析学开发,方法学开发委员会,贝尔斯（比利时）
●分析组2：全球分析学开发,稳定性评价和释药委员会,贝尔斯（比利时）
2.1.3 结论
粒径分布测定的方法AD-TM-R165335-F051-POW-LD-000959-v2已被验证其有适当的分析重复性和中间精密度.
2.2 稳健性
在方法学发展的过程中,分析方法的稳健性已被测试.并且分析方法的稳健性是对于在微小变化的工艺参数中,保持不受这种微小变化影响的能力.分析方法AD-TM-R165335-F051-LD-000959-v2保持不受影响的能力已被变化的下列参数测试.
1.滑动宽度（并包括由于滑动宽度,产品在仪器上的整体流动）
2.2.1 结论
在滑动宽度的微小变化后,通过方法的有效性,验证了分析方法的稳健性.
结论
这份方法有效性报告说明了对于结果和验收标准,测试方法AD-TM-R165335-F051-POW-LD-000959-v2的有效性.由于所有的接受标准已达到要求,这份报告说明了对于R165335-F051药品的粒径分布,测试方法是可行的.