In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding ...In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.展开更多
Quality control(QC)is an essential procedure in scatterometer wind retrieval,which is used to distinguish good-quality data from poor-quality wind vector cells(WVCs)for the sake of wind applications.The current wind p...Quality control(QC)is an essential procedure in scatterometer wind retrieval,which is used to distinguish good-quality data from poor-quality wind vector cells(WVCs)for the sake of wind applications.The current wind processor of the China-France Oceanography Satellite(CFOSAT)scatterometer(CSCAT)adopts a maximum likelihood estimator(MLE)-based QC method to filter WVCs affected by geophysical noise,such as rainfall and wind variability.As the first Ku-band rotating fan-beam scatterometer,CSCAT can acquire up to 16 observations over a single WVC,giving abundant information with diverse incidence/azimuth angles,as such its MLE statistical characteristics may be different from the previous scatterometers.In this study,several QC indicators,including MLE,its spatially averaged value(MLE_(m)),and the singularity exponents(SE),are analyzed using the collocated Global Precipitation Mission rainfall data as well as buoy data,to compare their sensitivity to rainfall and wind quality.The results show that wind error characteristics of CSCAT under different QC methods are similar to those of other Ku-band scatterometers,i.e.,SE is more suitable than other parameters for the wind QC at outer-swath and nadir regions,while MLE_(m) is the best QC indicator for the sweet region WVCs.Specifically,SE is much more favorable than others at high wind speeds.By combining different indicators,an improved QC method is developed for CSCAT.The validation with the collocated buoy data shows that it accepts more WVCs,and in turn,improves the quality control of CSCAT wind data.展开更多
基金supported by the Grant for Development of New Faculty Staff,Ratchadaphiseksomphot Endowment Fund,Chula-longkorn University,Thailand(Grant No.:DNS64_047_33_003_1 to Patanachai K.Limpikirati)Grant for Development of New Scholar,Office of the Permanent Secretary,Ministry of Higher Ed-ucation,Science,Research and Innovation,Thailand(Grant No.:RGNS64_012 to Patanachai K.Limpikirati).
文摘In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.
基金The National Key Research and Development Program of China under contract Nos 2022YFC3104900 and 2022YFC3104902.
文摘Quality control(QC)is an essential procedure in scatterometer wind retrieval,which is used to distinguish good-quality data from poor-quality wind vector cells(WVCs)for the sake of wind applications.The current wind processor of the China-France Oceanography Satellite(CFOSAT)scatterometer(CSCAT)adopts a maximum likelihood estimator(MLE)-based QC method to filter WVCs affected by geophysical noise,such as rainfall and wind variability.As the first Ku-band rotating fan-beam scatterometer,CSCAT can acquire up to 16 observations over a single WVC,giving abundant information with diverse incidence/azimuth angles,as such its MLE statistical characteristics may be different from the previous scatterometers.In this study,several QC indicators,including MLE,its spatially averaged value(MLE_(m)),and the singularity exponents(SE),are analyzed using the collocated Global Precipitation Mission rainfall data as well as buoy data,to compare their sensitivity to rainfall and wind quality.The results show that wind error characteristics of CSCAT under different QC methods are similar to those of other Ku-band scatterometers,i.e.,SE is more suitable than other parameters for the wind QC at outer-swath and nadir regions,while MLE_(m) is the best QC indicator for the sweet region WVCs.Specifically,SE is much more favorable than others at high wind speeds.By combining different indicators,an improved QC method is developed for CSCAT.The validation with the collocated buoy data shows that it accepts more WVCs,and in turn,improves the quality control of CSCAT wind data.
