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A risk-based approach to validation of ion chromatography methods using suppressed conductivity 利用抑制电导率验证离子色谱方法的基于风险的方法
AAPS Open Pub Date : 2021-12-01 DOI: 10.1186/s41120-021-00044-z
D. Nelson, G. D. Marbury
{"title":"A risk-based approach to validation of ion chromatography methods using suppressed conductivity","authors":"D. Nelson, G. D. Marbury","doi":"10.1186/s41120-021-00044-z","DOIUrl":"https://doi.org/10.1186/s41120-021-00044-z","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78382322","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
An industrial case study: QbD to accelerate time-to-market of a drug product 一个工业案例研究:QbD加速药品上市时间
AAPS Open Pub Date : 2021-12-01 DOI: 10.1186/s41120-021-00047-w
Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José C. Menezes, Cássio Yooiti Yamakawa
{"title":"An industrial case study: QbD to accelerate time-to-market of a drug product","authors":"Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José C. Menezes, Cássio Yooiti Yamakawa","doi":"10.1186/s41120-021-00047-w","DOIUrl":"https://doi.org/10.1186/s41120-021-00047-w","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78877904","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
Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach 用于皮肤癌的γ米扎酚乳质体凝胶:配方和使用质量设计(QbD)方法的优化
AAPS Open Pub Date : 2021-12-01 DOI: 10.1186/s41120-021-00041-2
Harsh S. Shah, Ankit Gotecha, D. Jetha, Amarjitsing Rajput, A. Bariya, S. Panchal, Shital B Butani
{"title":"Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach","authors":"Harsh S. Shah, Ankit Gotecha, D. Jetha, Amarjitsing Rajput, A. Bariya, S. Panchal, Shital B Butani","doi":"10.1186/s41120-021-00041-2","DOIUrl":"https://doi.org/10.1186/s41120-021-00041-2","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90266105","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
Tritium labeling of antisense oligonucleotides via different conjugation agents 不同偶联剂对反义寡核苷酸的氚标记
AAPS Open Pub Date : 2021-11-15 DOI: 10.1186/s41120-021-00040-3
Martin R. Edelmann, C. Husser, Martina B. Duschmalé, G. Fischer, C. Senn, Erich Koller, A. Brink
{"title":"Tritium labeling of antisense oligonucleotides via different conjugation agents","authors":"Martin R. Edelmann, C. Husser, Martina B. Duschmalé, G. Fischer, C. Senn, Erich Koller, A. Brink","doi":"10.1186/s41120-021-00040-3","DOIUrl":"https://doi.org/10.1186/s41120-021-00040-3","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78250589","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
AAPS open social media strategy (2021–2025) AAPS开放社交媒体战略(2021-2025)
AAPS Open Pub Date : 2021-11-15 DOI: 10.1186/s41120-021-00043-0
Harsh Shah
{"title":"AAPS open social media strategy (2021–2025)","authors":"Harsh Shah","doi":"10.1186/s41120-021-00043-0","DOIUrl":"https://doi.org/10.1186/s41120-021-00043-0","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79357992","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
A competitive ligand-binding assay for the detection of neutralizing antibodies against dostarlimab (TSR-042) 一种检测dostarlimab (TSR-042)中和抗体的竞争性配体结合试验
AAPS Open Pub Date : 2021-11-11 DOI: 10.1186/s41120-021-00039-w
X. Zhang, Hong Chen, Weiping Shao, Z. Lin, M. Melhem, Sharon M. Lu
{"title":"A competitive ligand-binding assay for the detection of neutralizing antibodies against dostarlimab (TSR-042)","authors":"X. Zhang, Hong Chen, Weiping Shao, Z. Lin, M. Melhem, Sharon M. Lu","doi":"10.1186/s41120-021-00039-w","DOIUrl":"https://doi.org/10.1186/s41120-021-00039-w","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78156217","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
Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies 电荷贴片对肿瘤处置和治疗性抗体生物分布的影响
AAPS Open Pub Date : 2021-09-01 DOI: 10.1101/2021.09.01.458024
Jakob C. Stüber, K. Rechberger, S. Miladinović, Thomas Pöschinger, Tamara Zimmermann, Remi Villenave, Miro J. Eigenmann, Thomas E. Kraft, D. Shah, H. Kettenberger, W. Richter
{"title":"Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies","authors":"Jakob C. Stüber, K. Rechberger, S. Miladinović, Thomas Pöschinger, Tamara Zimmermann, Remi Villenave, Miro J. Eigenmann, Thomas E. Kraft, D. Shah, H. Kettenberger, W. Richter","doi":"10.1101/2021.09.01.458024","DOIUrl":"https://doi.org/10.1101/2021.09.01.458024","url":null,"abstract":"This study explores the impact of antibody surface charge on tissue distribution into various tissues including tumor. Tumor-bearing mice were dosed intravenously with a mixture comprising three antibodies engineered to carry negative charge patches, a balanced charge distribution, or positive patches, respectively (cassette dosing). Tissue levels were analyzed with a specific LC-MS/MS method. In addition, the antibody mix was administered to non-tumor bearing mice. Muscle and skin interstitial fluid were obtained by centrifugation and analyzed by LC-MS/MS. An in vitro endothelium model was explored for its feasibility to mimic the observed distribution differences. A balanced charge distribution was optimal in terms of total tumor exposure, while in other tissues, negatively charged and balanced charged antibodies gave similar results. In contrast, positive charge patches generally resulted in increased serum clearance but markedly enhanced tumor and organ uptake, leading to higher tissue-to-serum ratios. The uptake and availability in the interstitial space were confirmed by specific assessment of antibody levels in the interstitial fluid of the muscle and skin, with similar charge impact as in total tissue. The in vitro model was able to differentiate the transport propensity of this series of antibody variants. In summary, our results show the differential effects of charge patches on an antibody surface on biodistribution and tumor uptake. These insights may help in the design of molecules with biodistribution properties tailored to their purpose, and an optimized safety profile.","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78433646","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
Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study 设计色谱方法评价分析质量过程中建模和模型验证的观点:一个案例研究
AAPS Open Pub Date : 2021-09-01 DOI: 10.1186/s41120-021-00037-y
Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser
{"title":"Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study","authors":"Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser","doi":"10.1186/s41120-021-00037-y","DOIUrl":"https://doi.org/10.1186/s41120-021-00037-y","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87117167","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
Pharmacokinetics and biodistribution of a novel anticancer thyrointegrin αvβ3 antagonist: triazole modified tetraiodothyroacetic acid conjugated to polyethylene glycol (P-bi-TAT) 新型抗癌甲状腺整合素αvβ3拮抗剂:三唑修饰聚乙二醇偶联四碘甲状腺乙酸(p - bitat)的药代动力学和生物分布
AAPS Open Pub Date : 2021-08-16 DOI: 10.1186/s41120-021-00036-z
K. Fujioka, Kavitha Godugu, S. Mousa
{"title":"Pharmacokinetics and biodistribution of a novel anticancer thyrointegrin αvβ3 antagonist: triazole modified tetraiodothyroacetic acid conjugated to polyethylene glycol (P-bi-TAT)","authors":"K. Fujioka, Kavitha Godugu, S. Mousa","doi":"10.1186/s41120-021-00036-z","DOIUrl":"https://doi.org/10.1186/s41120-021-00036-z","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75493480","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
Dawn of a new beginning 新开始的黎明
AAPS Open Pub Date : 2021-06-11 DOI: 10.1186/s41120-021-00035-0
Andrea Allmendinger
{"title":"Dawn of a new beginning","authors":"Andrea Allmendinger","doi":"10.1186/s41120-021-00035-0","DOIUrl":"https://doi.org/10.1186/s41120-021-00035-0","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86574826","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
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