A strategy for population pharmaceutical quality assessment based on quality by design

From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.

Population,Environment Dynamics,Poverty and Quality of Life in China

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Density and Fertilization Optimization for Highyielding Cultivation of a Wheat Variety Heibaoshi 1

The growth period, population tiller dynamics, plant characters, paniclegrain structure, yielding ability and stress resistance of a wheat variety Heibaoshi 1 were studied using a two-factor split plot design to investigate the effects of different density and fertilizer levels on individual development and yield of Heibaoshi 1 in riparian region of Jiangsu Province. In addition, high-yielding agronomic measures were explored through multiple non-linear regression analysis. The results showed that low density was not conducive to the formation of panicles, while high density affected grain number per panicle; low fertilizer level restricted individual development, while high fertilizer level affected grain number per panicle and grain weight and was prone to leading to lodging. Reasonable combination of density and fertilizer could coordinate individual development and balance panicle, grain and weight, thus achieving a high yield. The yield potential was highest （7 384.3 kg/hm2） under density of 239.6×104 basic seedlings/hm2 and N level of 237.7 kg/hm2. When the planting density ranged from 200×104 to 270×104 basic seedlings/hm2 and the N level ranged from 220 to 260 kg/hm2 or the density basic seedling number ranged from 210×104/hm2 to 260×104/hm2 and the N level ranged from 210 to 270 kg/hm2, the yield could exceed 7 200 kg/hm2.

Effects of Nitrogen Management on the Yield of Winter Wheat in Cold Area of Northeastern China

A plot experiment including four treatments, CK （N 105 kg ha-1 as urea, including a basal N application of 35 kg ha-I and a topdressing N 70 kg ha-1 at turned green stage） and optimized N management （OPT1, OPT2 and OPT3, applied two-thirds, one-third and two-fifths N at jointing stage, respectively, total N 60 kg ha-l）, was conducted to evaluate the effects of nitrogen management on growth and N uptake of winter wheat （Triticum aestivum）, Dongnong 1, which is the first highly cold tolerant winter wheat in China. Index of population quality, N uptake and yield were determined. The ear-bearing tiller rate was increased by above 12%, and the leaf area index, biomass and N uptake were significantly decreased （P〈O.05） at jointing stage. OPT treatments increased the grain to leaf area ratio at heading stage, the dry matter weight and N uptake after heading by 14.3-27.9%, 11.6-28.7% and 118.1-161.8 %, respectively. The yield of the OPT treatments was increased by 14.2-37.5% compared with CK, and there was a significant difference （P〈0.05） between CK and OPT1 treatments. Harvest index and N partial factor productivity （PFP, kg grain yield per kg N applied） was clearly enhanced from 0.4 and 35.6 kg, respectively for CK to an average of 0.48 （P〈0.05） and 77.6 kg （P〈0.05） in the OPT treatments. These results indicated that the optimized N management increased the harvest index, yield and N use efficiency by decreasing the N application rate and postponing N application time, improved wheat population quality, controlled excessive growth in the vegetative stages and increased dry matter and N accumulation rates after heading.

Quantitative Evaluation on the Comprehensive Benefit of Controlled-Release Fertilizer in Typically Middle-Low Yield Rice Field

Quantitative evaluation and analysis was made to the soil nutrients,rice yield,rice and fertilizer utilization rate,and economic and ecological benefits of the slow controlled release fertilizer in typical rice fields with middle-low yield by comparing the one-time application and split applications of slow-or controlledrelease fertilizer（ CRF） with farmers fertilizer practice as the control,with the aim to explore the effect of CRF. Results showed that compared with the control,the application of CRF could meet balance nutrients required for rice growth,and the effective panicles and seed-setting rate were higher in the treatment groups of FVOL,SVOL,LADVOLwhich applied CRF. As for soil nutrients,soil pH maintained balance in FVOL,FCAI,SVOL,LADVOL. In addition,differences in soil nutrient reduction amount reached the extremely significant level between FVOLand SXNK.SVOLwhich applied CRF provided reasonable regulation of N,P and K release rate,which showed advantages over blending fertilization and farmers fertilizer practice. Comprehensive analysis found that the application of CRF could make rice tillering growth and decline leveled off,which effectively improved the quality of rice population,and it also had higher input-output ratio than that of the control and good economic benefits. In general,CRF suits to be used widely on rice crop in the regions with medium-low yield.

Analysis of air quality characteristics of Beijing–Tianjin–Hebei and its surrounding air pollution transport channel cities in China

Beijing–Tianjin–Hebei(BTH)and its surrounding areas are very important to air pollution control in China.To analyze the characteristics of BTH and its surrounding areas of China,we collected 5,641,440 air quality data from 161 air monitoring stations and 37,123,000 continuous monitoring data from air polluting enterprises in BTH and surrounding cities to establish an indicator system for urban air quality portraits.The results showed that particulate matter with aerodynamic diameters of<2.5μm(PM2.5),particulate matter with aerodynamic diameters of<10μm(PM10)and SO2 improved significantly in 31 cities from2015 to 2018,but ozone deteriorated.Air quality in BTH and the surrounding areas showed obvious seasonal characteristics,among which PM2.5,PM10,SO2,and NO2 showed a"U"type distribution from January to December,while O3 had an"inverted U"distribution.The hourly changes in air quality revealed that peaks of PM2.5,PM10 and NO2 appeared from 8:00 to 10:00,while those for O3 appeared at 15:00–16:00.The exposure characteristics of the 31 cities showed that six districts in Beijing had the highest air quality population exposure,and that exposure levels in Zhengzhou,Puyang,Anyang,Jincheng were higher than the average of the 31 investigated cities.Additionally,multiple linear regression revealed a negative correlation between meteorological factors(especially wind and precipitation)and air quality,while a positive correlation existed between industrial pollution emissions and air quality in most of BTH and its surrounding cities.