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Reducing the Burden of Inspections on Pharmaceutical Manufacturers by Regulatory Authorities in Benin City, Nigeria 减轻尼日利亚贝宁市监管机构对制药商的检查负担
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1002
Joseph Ali, Esther Itua, Zita Ekeocha, Kari Clase, Stephen Byrn
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引用次数: 0
Improving Market Access with a Lean Approach to Quality 以精益质量方法改善市场准入
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1008
Bri'an Bigirwa, Zita Ekeocha, Stephen Byrn, Kari Clase
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引用次数: 0
GMP in the QC Laboratory and Analytical Method Validation 质量控制实验室的 GMP 和分析方法验证
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1003
Stephen Byrn, Zita Ekeocha, Martin Hynes, Roger Ongosi, Kari Clase
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引用次数: 0
Evaluating Active Content in Chloramphenicol Ophthalmic Solutions Available in a Low-Resource Setting: A Case Study 评估低资源环境中氯霉素眼药水的活性成分：案例研究
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1006
M. Okezue, Daniel T Smith, Kelvin Musaya, Nsabo Kihore, Zita Ekeocha, Timothy Nowak, Susan Roth, Mikyung Lee, Michael Stepanovic, Holly L Maize, Adebola Adekoya, Stephen Byrn, Kari Clase
{"title":"Evaluating Active Content in Chloramphenicol Ophthalmic Solutions Available in a Low-Resource Setting: A Case Study","authors":"M. Okezue, Daniel T Smith, Kelvin Musaya, Nsabo Kihore, Zita Ekeocha, Timothy Nowak, Susan Roth, Mikyung Lee, Michael Stepanovic, Holly L Maize, Adebola Adekoya, Stephen Byrn, Kari Clase","doi":"10.7771/2836-5666.1006","DOIUrl":"https://doi.org/10.7771/2836-5666.1006","url":null,"abstract":"","PeriodicalId":486855,"journal":{"name":"The Proceedings of the BIRS Community","volume":"63 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141272545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Investigating Using R, s, and x Charts in Monitoring Performance of Laboratory Equipment 使用 R、s 和 x 图表监测实验室设备性能的研究
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1005
M. Okezue, Stella Ebonine, Amoreen Naluyima, Emeka Akobundu, William Boogere-Wakaalo, Lasisi Olayonu, Rhoda Olayonu, Emanuel Akpan, Abubakar Umar, Kikundwa Emma Mbabazi, Nkem C Ifudu, Andrew Mukungu, Zita Ekeocha, Stephen Byrn, Kari Clase
{"title":"Investigating Using R, s, and x Charts in Monitoring Performance of Laboratory Equipment","authors":"M. Okezue, Stella Ebonine, Amoreen Naluyima, Emeka Akobundu, William Boogere-Wakaalo, Lasisi Olayonu, Rhoda Olayonu, Emanuel Akpan, Abubakar Umar, Kikundwa Emma Mbabazi, Nkem C Ifudu, Andrew Mukungu, Zita Ekeocha, Stephen Byrn, Kari Clase","doi":"10.7771/2836-5666.1005","DOIUrl":"https://doi.org/10.7771/2836-5666.1005","url":null,"abstract":"","PeriodicalId":486855,"journal":{"name":"The Proceedings of the BIRS Community","volume":"31 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141268967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of Next Generation Phage Applications Using -omics and Machine Learning 利用组学和机器学习技术开发下一代噬菌体应用程序
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1012
Lauren Novak, Kari Clase
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引用次数: 0
Continual Improvement in Laboratory Quality Management System of a Regulatory Laboratory in West Africa 西非监管实验室质量管理系统的持续改进
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1001
Nkem C Ifudu, Zita Ekeocha, Stephen Byrn, Kari Clase
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引用次数: 0
A Case Study on Completing Work in an Organizational Setting: Getting What You Need from Colleagues 关于在组织环境中完成工作的案例研究：从同事那里获取所需
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1009
Stacy Hoch, Stephen Byrn, Kari Clase
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引用次数: 0
Product Information Report: Gentamicin 产品信息报告：庆大霉素
The Proceedings of the BIRS Community Pub Date : 2024-06-03 DOI: 10.7771/2836-5666.1007
Stephen Byrn, Kari Clase, Zita Ekeocha, Farai Masekela
{"title":"Product Information Report: Gentamicin","authors":"Stephen Byrn, Kari Clase, Zita Ekeocha, Farai Masekela","doi":"10.7771/2836-5666.1007","DOIUrl":"https://doi.org/10.7771/2836-5666.1007","url":null,"abstract":"","PeriodicalId":486855,"journal":{"name":"The Proceedings of the BIRS Community","volume":"16 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141271126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular Basis of Manufacturing 制造的分子基础
The Proceedings of the BIRS Community Pub Date : 2023-09-28 DOI: 10.7771/2836-5666.1000
Stephen Byrn, Kari Clase
{"title":"Molecular Basis of Manufacturing","authors":"Stephen Byrn, Kari Clase","doi":"10.7771/2836-5666.1000","DOIUrl":"https://doi.org/10.7771/2836-5666.1000","url":null,"abstract":"This paper describes the Biotechnology Innovation and Regulatory Science course named The Molecular Basis of Manufacturing. This course covers drug manufacture including excipients, basic formulation, basic DOE analysis, and analysis of the final drug product (typically tablets or capsules). Molecular interpretation of formulations is discussed. The modules in the course are described as well as other course materials including quizzes and discussion questions. This paper will assist with the development of course in this area throughout the entire world.","PeriodicalId":486855,"journal":{"name":"The Proceedings of the BIRS Community","volume":"133 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135425466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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