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

FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023

2011-2023年FDA批准的用于儿科患者的孤儿药适应症

Kakkilaya, Apoorva; Shahzad, Mahnum; Bourgeois, Florence T

Aggressive Behavior among Adolescent Prisoners: Insights from a Study in Indonesia

印尼一项研究揭示了青少年囚犯的攻击性行为:

Wahyuni, Sri Eka; Daulay, Wardiyah; Purba, Jenny Marlindawani; Nasution, Mahnum Lailan

Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration's accelerated approval pathway: retrospective observational study and economic evaluation

通过美国食品药品监督管理局加速审批途径尽早获得新型癌症药物的成本和效益:回顾性观察研究和经济评价

Naci, Huseyin; Shahzad, Mahnum; Murphy, Peter; Zhang, Yichen; Costa, Rebecca; Ross, Joseph S; Wagner, Anita K

Threats of Weather Disasters for Drug Manufacturing Facilities in the US

美国药品生产设施面临的天气灾害威胁

Shahzad, Mahnum; Nogueira, Leticia M; Wagner, Anita

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

美国和欧洲近期撤回的3种PARP抑制剂卵巢癌治疗适应症的监管历史:对加速审批途径的启示

Shahzad, Mahnum; Naci, Huseyin; Esselen, Katharine M; Dottino, Joseph A; Wagner, Anita K

Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway

FDA加速审批途径中,上市前确证性试验启动与转为传统审批或撤回之间的关联

Shahzad, Mahnum; Naci, Huseyin; Wagner, Anita K

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval

美国食品药品监督管理局加速批准后,经证实缺乏临床疗效的癌症药物适应症的预计医疗保险支出

Shahzad, Mahnum; Naci, Huseyin; Wagner, Anita K