日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

通过美国FDA 505(j)或505(b)(2)审批途径,对复杂仿制药采取务实的监管方法

Klein, Kevin; Borchard, Gerrit; Shah, Vinod P; Flühmann, Beat; McNeil, Scott E; de Vlieger, Jon S B

Publisher Correction: On the issue of transparency and reproducibility in nanomedicine

出版商更正:关于纳米医学的透明度和可重复性问题

Leong, Hon S; Butler, Kimberly S; Brinker, C Jeffrey; Azzawi, May; Conlan, Steve; Dufès, Christine; Owen, Andrew; Rannard, Steve; Scott, Chris; Chen, Chunying; Dobrovolskaia, Marina A; Kozlov, Serguei V; Prina-Mello, Adriele; Schmid, Ruth; Wick, Peter; Caputo, Fanny; Boisseau, Patrick; Crist, Rachael M; McNeil, Scott E; Fadeel, Bengt; Tran, Lang; Hansen, Steffen Foss; Hartmann, Nanna B; Clausen, Lauge P W; Skjolding, Lars M; Baun, Anders; Ågerstrand, Marlene; Gu, Zhen; Lamprou, Dimitrios A; Hoskins, Clare; Huang, Leaf; Song, Wantong; Cao, Huiliang; Liu, Xuanyong; Jandt, Klaus D; Jiang, Wen; Kim, Betty Y S; Wheeler, Korin E; Chetwynd, Andrew J; Lynch, Iseult; Moghimi, Seyed Moein; Nel, André; Xia, Tian; Weiss, Paul S; Sarmento, Bruno; das Neves, José; Santos, Hélder A; Santos, Luis; Mitragotri, Samir; Little, Steve; Peer, Dan; Amiji, Mansoor M; Alonso, Maria José; Petri-Fink, Alke; Balog, Sandor; Lee, Aaron; Drasler, Barbara; Rothen-Rutishauser, Barbara; Wilhelm, Stefan; Acar, Handan; Harrison, Roger G; Mao, Chuanbin; Mukherjee, Priyabrata; Ramesh, Rajagopal; McNally, Lacey R; Busatto, Sara; Wolfram, Joy; Bergese, Paolo; Ferrari, Mauro; Fang, Ronnie H; Zhang, Liangfang; Zheng, Jie; Peng, Chuanqi; Du, Bujie; Yu, Mengxiao; Charron, Danielle M; Zheng, Gang; Pastore, Chiara

On the issue of transparency and reproducibility in nanomedicine

关于纳米医学的透明度和可重复性问题

Leong, Hon S; Butler, Kimberly S; Brinker, C Jeffrey; Azzawi, May; Conlan, Steve; Dufés, Christine; Owen, Andrew; Rannard, Steve; Scott, Chris; Chen, Chunying; Dobrovolskaia, Marina A; Kozlov, Serguei V; Prina-Mello, Adriele; Schmid, Ruth; Wick, Peter; Caputo, Fanny; Boisseau, Patrick; Crist, Rachael M; McNeil, Scott E; Fadeel, Bengt; Tran, Lang; Hansen, Steffen Foss; Hartmann, Nanna B; Clausen, Lauge P W; Skjolding, Lars M; Baun, Anders; Ågerstrand, Marlene; Gu, Zhen; Lamprou, Dimitrios A; Hoskins, Clare; Huang, Leaf; Song, Wantong; Cao, Huiliang; Liu, Xuanyong; Jandt, Klaus D; Jiang, Wen; Kim, Betty Y S; Wheeler, Korin E; Chetwynd, Andrew J; Lynch, Iseult; Moghimi, Seyed Moein; Nel, André; Xia, Tian; Weiss, Paul S; Sarmento, Bruno; das Neves, José; Santos, Hélder A; Santos, Luis; Mitragotri, Samir; Little, Steve; Peer, Dan; Amiji, Mansoor M; Alonso, Maria José; Petri-Fink, Alke; Balog, Sandor; Lee, Aaron; Drasler, Barbara; Rothen-Rutishauser, Barbara; Wilhelm, Stefan; Acar, Handan; Harrison, Roger G; Mao, Chuanbin; Mukherjee, Priyabrata; Ramesh, Rajagopal; McNally, Lacey R; Busatto, Sara; Wolfram, Joy; Bergese, Paolo; Ferrari, Mauro; Fang, Ronnie H; Zhang, Liangfang; Zheng, Jie; Peng, Chuanqi; Du, Bujie; Yu, Mengxiao; Charron, Danielle M; Zheng, Gang; Pastore, Chiara

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials"

美国药学科学家协会(AAPS)指导论坛关于FDA行业指导草案的报告:“含有纳米材料的药品,包括生物制品”

de Vlieger, Jon S B; Crommelin, Daan J A; Tyner, Katherine; Drummond, Daryl C; Jiang, Wenlei; McNeil, Scott E; Neervannan, Sesha; Crist, Rachael M; Shah, Vinod P

Safe anticoagulation when heart and lungs are "on vacation"

当心脏和肺部“休假”时,安全抗凝治疗

Dobrovolskaia, Marina A; McNeil, Scott E

Protein corona composition does not accurately predict hematocompatibility of colloidal gold nanoparticles

蛋白质冠状层组成并不能准确预测胶体金纳米粒子的血液相容性。

Dobrovolskaia, Marina A; Neun, Barry W; Man, Sonny; Ye, Xiaoying; Hansen, Matthew; Patri, Anil K; Crist, Rachael M; McNeil, Scott E

Longitudinal imaging of cancer cell metastases in two preclinical models: a correlation of noninvasive imaging to histopathology

在两种临床前模型中对癌细胞转移进行纵向成像:非侵入性成像与组织病理学的相关性

Adiseshaiah, Pavan P; Patel, Nimit L; Ileva, Lilia V; Kalen, Joseph D; Haines, Diana C; McNeil, Scott E

Understanding the correlation between in vitro and in vivo immunotoxicity tests for nanomedicines

了解纳米药物体外和体内免疫毒性试验之间的相关性

Dobrovolskaia, Marina A; McNeil, Scott E

Synergistic combination therapy with nanoliposomal C6-ceramide and vinblastine is associated with autophagy dysfunction in hepatocarcinoma and colorectal cancer models.

纳米脂质体 C6-神经酰胺与长春碱的协同联合治疗与肝癌和结直肠癌模型中的自噬功能障碍有关

Adiseshaiah Pavan P, Clogston Jeffrey D, McLeland Christopher B, Rodriguez Jamie, Potter Timothy M, Neun Barry W, Skoczen Sarah L, Shanmugavelandy Sriram S, Kester Mark, Stern Stephan T, McNeil Scott E

Polymeric curcumin nanoparticle pharmacokinetics and metabolism in bile duct cannulated rats

聚合物姜黄素纳米颗粒在胆管插管大鼠体内的药代动力学和代谢

Zou, Peng; Helson, Lawrence; Maitra, Anirban; Stern, Stephan T; McNeil, Scott E