A newfangled study using risk silhouette and uncertainty approximation for quantification of acyclovir in diverse formulation

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.

A review of progress in coupled ocean-atmosphere model developments for ENSO studies in China

El Nino-Southern Oscillation(ENSO) is the strongest interannual signal that is producedby basinscale processes in the tropical Pacific,with significant effects on weather and climate worldwide.In the past,extensive and intensive international efforts have been devoted to coupled model developments for ENSO studies.A hierarchy of coupled ocean-atmo sphere models has been formulated;in terms of their complexity,they can be categorized into intermediate coupled models(ICMs),hybrid coupled models(HCMs),and fully coupled general circulation models(CGCMs).ENSO modeling has made significant progress over the past decades,reaching a stage where coupled models can now be used to successfully predict ENSO events 6 months to one year in advance.Meanwhile,ENSO exhibits great diversity and complexity as observed in nature,which still cannot be adequately captured by current state-of-the-art coupled models,presenting a challenge to ENSO modeling.We primarily reviewed the long-term efforts in ENSO modeling continually and steadily made at different institutions in China;some selected representative examples are presented here to review the current status of ENSO model developments and applications,which have been actively pursued with noticeable progress being made recently.As ENSO simulations are very sensitive to model formulations and process representations etc.,dedicated efforts have been devoted to ENSO model developments and improvements.Now,different ocean-atmosphere coupled models have been available in China,which exhibit good model performances and have already had a variety of applications to climate modeling,including the Coupled Model Intercomparison Project Phase 6(CMIP6).Nevertheless,large biases and uncertainties still exist in ENSO simulations and predictions,and there are clear rooms for their improvements,which are still an active area of researches and applications.Here,model performances of ENSO simulations are assessed in terms of advantages and disadvantages with these differently formulated coupled models,pinpointing to the areas where they need to be further improved for ENSO studies.These analyses provide valuable guidance for future improvements in ENSO simulations and predictions.