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Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection 抗体-药物偶联物:在先导物优化和选择中的综合生物分析和生物处置评估
AAPS Open Pub Date : 2018-08-08 DOI: 10.1186/s41120-018-0026-0
M. Beaumont, D. Tomazela, D. Hodges, G. Ermakov, Edward Hsieh, I. Figueroa, O. So, Yaoli Song, Huiping Ma, S. Antonenko, Wondwessen Mengesha, Yi Wei Zhang, Shuli Zhang, S. Hseih, G. Ayanoglu, Xiaoyan Du, E. Rimmer, Michael Judo, F. Vives, J. Yearley, C. Moon, Anthony Manibusan, Nick A. Knudsen, Andrew Beck, D. Bresson, D. Gately, D. Neupane, E. Escandón
{"title":"Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection","authors":"M. Beaumont, D. Tomazela, D. Hodges, G. Ermakov, Edward Hsieh, I. Figueroa, O. So, Yaoli Song, Huiping Ma, S. Antonenko, Wondwessen Mengesha, Yi Wei Zhang, Shuli Zhang, S. Hseih, G. Ayanoglu, Xiaoyan Du, E. Rimmer, Michael Judo, F. Vives, J. Yearley, C. Moon, Anthony Manibusan, Nick A. Knudsen, Andrew Beck, D. Bresson, D. Gately, D. Neupane, E. Escandón","doi":"10.1186/s41120-018-0026-0","DOIUrl":"https://doi.org/10.1186/s41120-018-0026-0","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77764874","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: 6
Nano-formulations composed of cell membrane-specific cellular lipid extracts derived from target cells: physicochemical characterization and in vitro evaluation using cellular models of breast carcinoma 由靶细胞提取的细胞膜特异性细胞脂质提取物组成的纳米制剂:乳腺癌细胞模型的理化特性和体外评价
AAPS Open Pub Date : 2018-07-23 DOI: 10.1186/s41120-018-0025-1
Hanan M Alharbi, R. B. Campbell
{"title":"Nano-formulations composed of cell membrane-specific cellular lipid extracts derived from target cells: physicochemical characterization and in vitro evaluation using cellular models of breast carcinoma","authors":"Hanan M Alharbi, R. B. Campbell","doi":"10.1186/s41120-018-0025-1","DOIUrl":"https://doi.org/10.1186/s41120-018-0025-1","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75668615","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: 3
Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC) 制定衡量亚太经合组织(APEC)区域监管趋同与合作进展的关键绩效指标
AAPS Open Pub Date : 2018-05-31 DOI: 10.1186/s41120-018-0024-2
S. Chong, John C W Lim, T. Tominaga
{"title":"Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC)","authors":"S. Chong, John C W Lim, T. Tominaga","doi":"10.1186/s41120-018-0024-2","DOIUrl":"https://doi.org/10.1186/s41120-018-0024-2","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76976018","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: 7
A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects 一项随机、开放标签研究，评估两种0.5 mg芬戈莫德制剂在健康受试者中的生物等效性
AAPS Open Pub Date : 2018-03-09 DOI: 10.1186/s41120-018-0023-3
M. Tanguay, Thomas Fröhlich, M. Drouin, G. Beuerle
{"title":"A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects","authors":"M. Tanguay, Thomas Fröhlich, M. Drouin, G. Beuerle","doi":"10.1186/s41120-018-0023-3","DOIUrl":"https://doi.org/10.1186/s41120-018-0023-3","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85567810","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: 2
Stability challenges not addressed by harmonized guidance – AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD 2017年4月3日至4日在马里兰州Rockville举行的AAPS稳定性焦点小组研讨会上，统一指南未解决稳定性挑战
AAPS Open Pub Date : 2018-02-14 DOI: 10.1186/s41120-018-0022-4
M. M. Khan, Bowen Jiang, A. Mazzeo, Kim Huynh-Ba
{"title":"Stability challenges not addressed by harmonized guidance – AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD","authors":"M. M. Khan, Bowen Jiang, A. Mazzeo, Kim Huynh-Ba","doi":"10.1186/s41120-018-0022-4","DOIUrl":"https://doi.org/10.1186/s41120-018-0022-4","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85000923","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: 3
Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia 非霍奇金淋巴瘤和急性淋巴细胞白血病患者的临床免疫原性评价
AAPS Open Pub Date : 2018-02-07 DOI: 10.1186/s41120-018-0021-5
D. Jani, J. Nowak, Ying Chen, J. Boni, B. Gorovits
{"title":"Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia","authors":"D. Jani, J. Nowak, Ying Chen, J. Boni, B. Gorovits","doi":"10.1186/s41120-018-0021-5","DOIUrl":"https://doi.org/10.1186/s41120-018-0021-5","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80079114","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: 4
Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis 在线患者社区与药物标签处方药物恶心副作用率的比较:一项探索性分析
AAPS Open Pub Date : 2017-11-20 DOI: 10.1186/s41120-017-0020-y
D. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, P. Wicks, J. Weatherall
{"title":"Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis","authors":"D. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, P. Wicks, J. Weatherall","doi":"10.1186/s41120-017-0020-y","DOIUrl":"https://doi.org/10.1186/s41120-017-0020-y","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81703043","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: 3
Plasma modification of microporous polymer membranes for application in biomimetic dissolution studies 等离子体修饰微孔聚合物膜在仿生溶解研究中的应用
AAPS Open Pub Date : 2017-10-24 DOI: 10.1186/s41120-017-0019-4
M. Puppolo, J. Hughey, Bruce Weber, Traciann Dillon, D. Storey, Elizabeth B. Cerkez, S. Jansen-Varnum
{"title":"Plasma modification of microporous polymer membranes for application in biomimetic dissolution studies","authors":"M. Puppolo, J. Hughey, Bruce Weber, Traciann Dillon, D. Storey, Elizabeth B. Cerkez, S. Jansen-Varnum","doi":"10.1186/s41120-017-0019-4","DOIUrl":"https://doi.org/10.1186/s41120-017-0019-4","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83002592","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
AAPS Workshop: accelerating pharmaceutical development through predictive stability approaches, April 4–5, 2016 AAPS研讨会:通过预测稳定性方法加速药物开发，2016年4月4日至5日
AAPS Open Pub Date : 2017-09-06 DOI: 10.1186/s41120-017-0018-5
A. Freed, S. Colgan, J. Kochling, M. Alasandro
{"title":"AAPS Workshop: accelerating pharmaceutical development through predictive stability approaches, April 4–5, 2016","authors":"A. Freed, S. Colgan, J. Kochling, M. Alasandro","doi":"10.1186/s41120-017-0018-5","DOIUrl":"https://doi.org/10.1186/s41120-017-0018-5","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74195138","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: 10
New directions in pharmaceutical amorphous materials and amorphous solid dispersions, a tribute to Professor George Zografi – Proceedings of the June 2016 Land O’Lakes Conference 医药非晶材料和非晶固体分散体的新方向，致敬George Zografi教授- 2016年6月Land O 'Lakes会议论文集
AAPS Open Pub Date : 2017-08-11 DOI: 10.1186/s41120-017-0017-6
A. Newman, J. Hastedt, M. Yazdanian
{"title":"New directions in pharmaceutical amorphous materials and amorphous solid dispersions, a tribute to Professor George Zografi – Proceedings of the June 2016 Land O’Lakes Conference","authors":"A. Newman, J. Hastedt, M. Yazdanian","doi":"10.1186/s41120-017-0017-6","DOIUrl":"https://doi.org/10.1186/s41120-017-0017-6","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82199959","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: 16
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