A newfangled study using risk silhouette and uncertainty approximation for quantification of acyclovir in diverse formulation / 药物分析学报

Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results. Additionally, there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug product. In the present work, evaluation of risk profile, combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were studied. Uncertainty was calculated using cause-effect approach, and to make it more accurately applicable a method was validated in our laboratory as per the ICH guidelines. While assessing the results of validation, the calibration model was justified by the lack of fit and Levene’s test. Risk profile represents the future applications of this method. In uncertainty the major contribution is due to sample concentration and mass. This work demonstrates the application of theoretical concepts of calibration model tests, relative bias, risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.

Verification Assessment in Three Hematology Analyzers / 医疗卫生装备

Objective To evaluate the veracity and consistency of the results obtained from three automated hematology an-alyzers. Methods The reproducibility tests were used to assess the precision,the verification tests were exerted to evaluate the accuracy and consistency of test parameters(WBC,RBC,Hb,Hct and Plt) of the three hematology analyzers. According to the 1/2 standard of American Clinical Laboratory Improvement Amendment (CLIA,88),the relative bias of the reference analyzer and other assessed analyzers were determined. Results The results obtained from the three analyzers showed ex-cellent precision and stability,the coefficients of variation (CV) were all less than 5%; compared with the results of LH750,the results of Gens 5diff and ACT-5diff showed excellent correlation,all coefficients of correlation(?) exceeded 0.975. The results of both RBC and Hct obtained from Gens 5diff and ACT-5diff exceeded allowable error; the results of WBC,Hb and Plt were in the allowable error range. Conclusion In the condition of the excellent precision and stability,system errors existed in the analyzer can be found by verification on time. Through being adjusted and calibrated,the hematology ana-lyzers can meet the requirements and these results are consistent.