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Nonclinical Considerations for Biopharmaceutical Comparability Assessment* 生物制药可比性评估的非临床考虑*
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-11
C. E. Ellis, M. Hartsough
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引用次数: 0
Nonclinical Development of Biologics for Infectious Diseases 感染性疾病生物制剂的非临床开发
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-35
B. B. Smith
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引用次数: 0
Biosimilar Products—A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies 生物仿制药——临床前安全性研究的过去和现在的监管批准标准综述
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-15
A. Kimzey, K. Mease, B. Mounho-Zamora, M. Wood
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引用次数: 0
Key Considerations in the Chemistry, Manufacturing, and Controls of Biopharmaceuticals 生物制药的化学、制造和控制中的关键因素
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-8
Sara McKenzie, Edward R. Branson
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引用次数: 0
Cellular-Based Therapies 基于细胞的治疗
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-28
E. Feigal, M. E. Cosenza
{"title":"Cellular-Based Therapies","authors":"E. Feigal, M. E. Cosenza","doi":"10.1201/9781003124542-28","DOIUrl":"https://doi.org/10.1201/9781003124542-28","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48824853","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: 1
Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions 神经退行性疾病生物治疗的非临床安全程序考虑
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-34
D. Hovland, B. B. Smith, C. W. Chen
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引用次数: 0
Preclinical Toxicology Testing Paradigms 临床前毒理学测试范式
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-9
J. Cavagnaro
{"title":"Preclinical Toxicology Testing Paradigms","authors":"J. Cavagnaro","doi":"10.1201/9781003124542-9","DOIUrl":"https://doi.org/10.1201/9781003124542-9","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45873946","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
Antibodies (Abs) and Related Products Containing Complementarity-Determining Regions (CDRs) 含有互补决定区(cdr)的抗体(Abs)及其制品
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-23
M. Leach
{"title":"Antibodies (Abs) and Related Products Containing Complementarity-Determining Regions (CDRs)","authors":"M. Leach","doi":"10.1201/9781003124542-23","DOIUrl":"https://doi.org/10.1201/9781003124542-23","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43173360","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: 1
Nonclinical Safety Evaluation of Therapies for Rare Diseases 罕见病治疗的非临床安全性评价
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-24
K. McKeever, T. Maclachlan
{"title":"Nonclinical Safety Evaluation of Therapies for Rare Diseases","authors":"K. McKeever, T. Maclachlan","doi":"10.1201/9781003124542-24","DOIUrl":"https://doi.org/10.1201/9781003124542-24","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44247949","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
Genome Editing Technologies 基因组编辑技术
Translational medicine (Sunnyvale, Calif.) Pub Date : 2021-10-01 DOI: 10.1201/9781003124542-30
K. Meyer-Tamaki
{"title":"Genome Editing Technologies","authors":"K. Meyer-Tamaki","doi":"10.1201/9781003124542-30","DOIUrl":"https://doi.org/10.1201/9781003124542-30","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45204978","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: 11
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