Overall, PK methodologies in clinical trials play a critical role in drug development, helping to optimize dosing regimens, ensure patient safety, and facilitate regulatory approval.总的来说,临床试验中的PK方法学在药物开发中扮演着至关重要的角色,有助于优化给药方案、确保患者的安全,并促进药物的监管批准...
表3 聚合胶束相关药物临床试验(clinicaltrials.gov)[15] 胶束在口服药物中的应用 据报道,塞来昔布口服给药系统使用的是由Soluplus®(聚乙烯己内酰胺-聚乙酸乙烯酯-聚乙二醇接枝共聚物)和Kolliphor®HS-15(聚乙二醇(15)-羟基硬脂酸酯)聚合物形成的胶束。研究发现,与上市配方相比,胶束可提高药物在大鼠体内的生物利用...
表3 聚合胶束相关药物临床试验(clinicaltrials.gov)[15] 胶束在口服药物中的应用 据报道,塞来昔布口服给药系统使用的是由Soluplus®(聚乙烯己内酰胺-聚乙酸乙烯酯-聚乙二醇接枝共聚物)和Kolliphor®HS-15(聚乙二醇(15)-羟基硬脂酸酯)聚合物形成的胶束。研究发现,与上市配方相比,胶束可提高药物在大鼠体内的生物利...
[5]MacVane SH, Kuti JL, Nicolau DP,Prolongingβ-lactam infusion: a review of the rationale and evidence, and guidance for implementation. Int J Antimicrob Agents. 2014 Feb;43(2):105-13. Epub 2013 Nov 24. [6]Yu Z, et al. Clinical outcomes of prolonged infusion (extended infusion or...
持续输注(Continuous infusion,CI),即覆盖整个给药间隔。 延时输注(Extended infusion,EI),即延长输注给药时间至2-4小时。 02 不同PI策略对美罗培南肺内PK/PD的影响 ■重症HAP患者肺局部PK/PD监测 重症患者体内药物代谢变化各异,临床医生常常有这样的体会,即便分离...
[2] Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. ...
在膝下动脉疾病导致的CLTI患者中,在主要疗效终点方面,使用依维莫司洗脱可吸收支架优于血管成形术。(由Abbott[雅培]资助; LIFE-BTK在ClinicalTrials.gov注册号为NCT04227899。) 该随机对照临床试验是来自澳大利亚、米国、新加坡、中国台湾省等地区的研究人员组成的联合研究组(LIFE-BTK Investigators)完成的。通讯作者是来...
10. Raimondi A, Morano F, Trarbach T, et al. Optimal maintenance treatment strategy following an anti-EGFR-based first-line induction therapy in patients with RAS wild type metastatic colorectal cancer: An individual patient data pooled analysis of clinical trials. Presented at: ESMO World Congre...
PK in Late Phase TrialsKevin KrudysApplied Clinical Trials
10. Raimondi A, Morano F, Trarbach T, et al. Optimal maintenance treatment strategy following an anti-EGFR-based first-line induction therapy in patients with RAS wild type metastatic colorectal cancer: An individual patient data pooled analysis of clinical trials. Presented at: ESMO World Congre...