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Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study 蛋白基药物产品中聚山梨酸酯20酶解诱导的颗粒形成的配方缓解:来自全因子纵向研究的见解
AAPS Open Pub Date : 2022-11-14 DOI: 10.1186/s41120-022-00064-3
Inn H. Yuk, T. Koulis, Nidhi Doshi, Kathrin Gregoritza, Constanze Hediger, Vanessa Lebouc-Haefliger, Jamie Giddings, T. Khan
{"title":"Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study","authors":"Inn H. Yuk, T. Koulis, Nidhi Doshi, Kathrin Gregoritza, Constanze Hediger, Vanessa Lebouc-Haefliger, Jamie Giddings, T. Khan","doi":"10.1186/s41120-022-00064-3","DOIUrl":"https://doi.org/10.1186/s41120-022-00064-3","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"22 1","pages":"1-22"},"PeriodicalIF":0.0,"publicationDate":"2022-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86804734","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
Results from in vitro and in vivo studies evaluating the bioavailability, effects of food, and administration as crushed tablet suspension on vericiguat pharmacokinetics 体外和体内研究的结果，评估生物利用度，食物的影响，以及作为碎片悬浮液给药对临床药代动力学的影响
AAPS Open Pub Date : 2022-11-01 DOI: 10.1186/s41120-022-00063-4
C. Becker, M. Boettcher, Uwe Muenster, Stephanie Loewen, M. Lobmeyer, W. Mueck
{"title":"Results from in vitro and in vivo studies evaluating the bioavailability, effects of food, and administration as crushed tablet suspension on vericiguat pharmacokinetics","authors":"C. Becker, M. Boettcher, Uwe Muenster, Stephanie Loewen, M. Lobmeyer, W. Mueck","doi":"10.1186/s41120-022-00063-4","DOIUrl":"https://doi.org/10.1186/s41120-022-00063-4","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"37 1","pages":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84856821","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
Stability of levothyroxine tablets in blister packaging versus bottles and vials under simulated in-use conditions 模拟使用条件下吸塑包装左旋甲状腺素片与瓶装和小瓶的稳定性
AAPS Open Pub Date : 2022-10-10 DOI: 10.1186/s41120-022-00062-5
Jonathan Chun
{"title":"Stability of levothyroxine tablets in blister packaging versus bottles and vials under simulated in-use conditions","authors":"Jonathan Chun","doi":"10.1186/s41120-022-00062-5","DOIUrl":"https://doi.org/10.1186/s41120-022-00062-5","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"2 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2022-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72609576","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
Technical transfer and commercialisation of lyophilised biopharmaceuticals — application of lyophiliser characterisation and comparability 冻干生物制药的技术转让和商业化-冻干机特性和可比性的应用
AAPS Open Pub Date : 2022-09-01 DOI: 10.1186/s41120-022-00059-0
S. Cullen, Emma Walsh, V. Gervasi, Dikshitkumar Khamar, T. McCoy
{"title":"Technical transfer and commercialisation of lyophilised biopharmaceuticals — application of lyophiliser characterisation and comparability","authors":"S. Cullen, Emma Walsh, V. Gervasi, Dikshitkumar Khamar, T. McCoy","doi":"10.1186/s41120-022-00059-0","DOIUrl":"https://doi.org/10.1186/s41120-022-00059-0","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75720358","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
PLGA-based nanoparticles for the treatment of cancer: current strategies and perspectives 基于plga的纳米颗粒治疗癌症:当前的策略和观点
AAPS Open Pub Date : 2022-08-01 DOI: 10.1186/s41120-022-00060-7
M. Alvi, Azka Yaqoob, K. Rehman, Syed Muhammad Shoaib, M. Akash
{"title":"PLGA-based nanoparticles for the treatment of cancer: current strategies and perspectives","authors":"M. Alvi, Azka Yaqoob, K. Rehman, Syed Muhammad Shoaib, M. Akash","doi":"10.1186/s41120-022-00060-7","DOIUrl":"https://doi.org/10.1186/s41120-022-00060-7","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82435002","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: 17
Correction: Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM) 更正:高生物利用度白藜芦醇制剂(JOTROL TM)的安全性和药代动力学
AAPS Open Pub Date : 2022-07-27 DOI: 10.1186/s41120-022-00061-6
Christopher J. Kemper, D. Behnam, S. Brothers, C. Wahlestedt, C. Volmar, Daniel Bennett, M. Hayward
{"title":"Correction: Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM)","authors":"Christopher J. Kemper, D. Behnam, S. Brothers, C. Wahlestedt, C. Volmar, Daniel Bennett, M. Hayward","doi":"10.1186/s41120-022-00061-6","DOIUrl":"https://doi.org/10.1186/s41120-022-00061-6","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"42 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73864381","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
Utilizing cross-product prior knowledge to rapidly de-risk chemical liabilities in therapeutic antibody candidates 利用交叉产品先验知识，快速降低治疗性抗体候选物的化学责任风险
AAPS Open Pub Date : 2022-05-23 DOI: 10.1186/s41120-022-00057-2
Alex W. Jacobitz, Wilfredo Rodezno, Neeraj J. Agrawal
{"title":"Utilizing cross-product prior knowledge to rapidly de-risk chemical liabilities in therapeutic antibody candidates","authors":"Alex W. Jacobitz, Wilfredo Rodezno, Neeraj J. Agrawal","doi":"10.1186/s41120-022-00057-2","DOIUrl":"https://doi.org/10.1186/s41120-022-00057-2","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"223 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73018176","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
Molecular docking assisted exploration on solubilization of poorly soluble drug remdesivir in sulfobutyl ether-tycyclodextrin 分子对接辅助探索难溶性药物瑞德西韦在巯基丁基醚-环糊精中的增溶作用
AAPS Open Pub Date : 2022-04-25 DOI: 10.1186/s41120-022-00054-5
Yumeng Zhang, Zhouming Zhao, Kai Wang, Kangjie Lyu, Cai Yao, Lin Li, X. Shen, Tengfei Liu, Xiaodi Guo, Haiyan Li, Wenshou Wang, Tsai-Ta C. Lai
{"title":"Molecular docking assisted exploration on solubilization of poorly soluble drug remdesivir in sulfobutyl ether-tycyclodextrin","authors":"Yumeng Zhang, Zhouming Zhao, Kai Wang, Kangjie Lyu, Cai Yao, Lin Li, X. Shen, Tengfei Liu, Xiaodi Guo, Haiyan Li, Wenshou Wang, Tsai-Ta C. Lai","doi":"10.1186/s41120-022-00054-5","DOIUrl":"https://doi.org/10.1186/s41120-022-00054-5","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"465 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77487501","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
Heat pre-treatment can abolish anti-drug antibody interference in ligand binding pharmacokinetic assays 热预处理可以消除抗药抗体对配体结合药代动力学分析的干扰
AAPS Open Pub Date : 2022-04-11 DOI: 10.1186/s41120-022-00056-3
Svend Poulsen, L. Jørgensen, P. Galle
{"title":"Heat pre-treatment can abolish anti-drug antibody interference in ligand binding pharmacokinetic assays","authors":"Svend Poulsen, L. Jørgensen, P. Galle","doi":"10.1186/s41120-022-00056-3","DOIUrl":"https://doi.org/10.1186/s41120-022-00056-3","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83391238","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
Pharmacokinetic and pharmacodynamic analyses of terlipressin in patients with hepatorenal syndrome 特利加压素在肝肾综合征患者中的药动学和药效学分析
AAPS Open Pub Date : 2022-04-04 DOI: 10.1186/s41120-022-00052-7
Xiaofeng Wang, K. Jamil
{"title":"Pharmacokinetic and pharmacodynamic analyses of terlipressin in patients with hepatorenal syndrome","authors":"Xiaofeng Wang, K. Jamil","doi":"10.1186/s41120-022-00052-7","DOIUrl":"https://doi.org/10.1186/s41120-022-00052-7","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75837753","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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