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
Chinese Medicine Enema is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The"International Standard of Traditional Chinese Medicine Techniques:The Operati...Chinese Medicine Enema is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The"International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicine Enema is drawn up by the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.展开更多
Chinese medicated bath is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The“International Standard of Traditional Chinese Medicine Techniques:The Operating S...Chinese medicated bath is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The“International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicated Bath”is drawn up by the Beijing University of Chinese Medicine Third Affiliated Hospital and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.展开更多
A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding ...A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding of multiple parts on a single machine in automobile factories. The system incorporates an automatic recognition system for different workpiece materials using the added machine fixture,visual detection system for nuts and bolts,and secondary graphical confirmation to ensure the correctness of specification calling. This system achieves reliable,fully automatic selection of welding specifications in resistance welding equipment and has shown significant effects in improving welding quality for massproduced workpieces,while solving the problem of specification calling errors that can occur with traditional methods involving process charts and code adjustments. This system is particularly suitable for promoting applications in manual welding of multiple parts on a single machine in automobile factories,ensuring correct specification calling and welding quality.展开更多
Acute mastitis is one of the common diseases of postpartum lactating women,also known as lactational mastitis,which can occur during breastfeeding,especially in the postpartum 3–4 weeks.Acute mastitis can lead to the...Acute mastitis is one of the common diseases of postpartum lactating women,also known as lactational mastitis,which can occur during breastfeeding,especially in the postpartum 3–4 weeks.Acute mastitis can lead to the cessation of breastfeeding.Improving breastfeeding behavior and extending breastfeeding duration have become a global strategy to promote maternal and child health.Manual lactation traditional Chinese medicine technology is one of the important measures to improve the rate of breastfeeding,which can solve the problems of breast swelling,pain,and reduction of milk production.This article introduces the definition,indications,standard operating procedures,precautions,and treatment of adverse events of manual lactation in traditional Chinese medicine technology,so as to provide more comprehensive guidance for clinical workers to carry out manual lactation operations.展开更多
Automatic extraction of key data from design specifications is an important means to assist in engineering design automation.Considering the characteristics of diverse data types,small scale,insufficient character inf...Automatic extraction of key data from design specifications is an important means to assist in engineering design automation.Considering the characteristics of diverse data types,small scale,insufficient character information content and strong contextual relevance of design specification,a named entity recognition model integrated with high-quality topic and attention mechanism,namely Quality Topic-Char Embedding-BiLSTMAttention-CRF,was proposed to automatically identify entities in design specification.Based on the topic model,an improved algorithm for high-quality topic extraction was proposed first,and then the high-quality topic information obtained was added into the distributed representation of Chinese characters to better enrich character features.Next,the attention mechanism was used in parallel on the basis of the BiLSTM-CRF model to fully mine the contextual semantic information.Finally,the experiment was performed on the collected corpus of Chinese ship design specification,and the model was compared with multiple sets of models.The results show that F-score(harmonic mean of precision and recall)of the model is 80.24%.The model performs better than other models in design specification,and is expected to provide an automatic means for engineering design.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National Key R&D Plan:Development of International Standards for Traditional Chinese Medicine Technology(No.2019YFC1712003)。
文摘Chinese Medicine Enema is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The"International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicine Enema is drawn up by the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.
基金National Key R&D Plan:Development of International Standards for Traditional Chinese Medicine Technology(No.2019YFC1712003)。
文摘Chinese medicated bath is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The“International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicated Bath”is drawn up by the Beijing University of Chinese Medicine Third Affiliated Hospital and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.
文摘A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding of multiple parts on a single machine in automobile factories. The system incorporates an automatic recognition system for different workpiece materials using the added machine fixture,visual detection system for nuts and bolts,and secondary graphical confirmation to ensure the correctness of specification calling. This system achieves reliable,fully automatic selection of welding specifications in resistance welding equipment and has shown significant effects in improving welding quality for massproduced workpieces,while solving the problem of specification calling errors that can occur with traditional methods involving process charts and code adjustments. This system is particularly suitable for promoting applications in manual welding of multiple parts on a single machine in automobile factories,ensuring correct specification calling and welding quality.
基金This work was sponsored by 2022 Capital’s Funds for Health Improvement and Research(CFH)(2022-2-4202).
文摘Acute mastitis is one of the common diseases of postpartum lactating women,also known as lactational mastitis,which can occur during breastfeeding,especially in the postpartum 3–4 weeks.Acute mastitis can lead to the cessation of breastfeeding.Improving breastfeeding behavior and extending breastfeeding duration have become a global strategy to promote maternal and child health.Manual lactation traditional Chinese medicine technology is one of the important measures to improve the rate of breastfeeding,which can solve the problems of breast swelling,pain,and reduction of milk production.This article introduces the definition,indications,standard operating procedures,precautions,and treatment of adverse events of manual lactation in traditional Chinese medicine technology,so as to provide more comprehensive guidance for clinical workers to carry out manual lactation operations.
基金the High Tech Ship Project of the Ministry of Industry and Information Technology(No.[2019]331)。
文摘Automatic extraction of key data from design specifications is an important means to assist in engineering design automation.Considering the characteristics of diverse data types,small scale,insufficient character information content and strong contextual relevance of design specification,a named entity recognition model integrated with high-quality topic and attention mechanism,namely Quality Topic-Char Embedding-BiLSTMAttention-CRF,was proposed to automatically identify entities in design specification.Based on the topic model,an improved algorithm for high-quality topic extraction was proposed first,and then the high-quality topic information obtained was added into the distributed representation of Chinese characters to better enrich character features.Next,the attention mechanism was used in parallel on the basis of the BiLSTM-CRF model to fully mine the contextual semantic information.Finally,the experiment was performed on the collected corpus of Chinese ship design specification,and the model was compared with multiple sets of models.The results show that F-score(harmonic mean of precision and recall)of the model is 80.24%.The model performs better than other models in design specification,and is expected to provide an automatic means for engineering design.
