Category: 白皮书
Key Trends in U.S. Specialty Pharmacy
The Escalating U.S. Policy Environment
为新型疗法提供创新融资
The Rise of Cost Effectiveness Considerations in the US
通过外包实施 eCTD
使用 9 型 NDA 指定加速药物产品的多次批准
在 COVID-19 期间管理临床试验和监管申报策略的注意事项
Regulatory Agencies across the world have quickly responded to the COVID-19 pandemic. Your approach to ongoing and new clinical trials and regulatory filing during COVID-19 requires adaptation and new strategies, such as following recommendations and using the fast-track COVID-19 programs recently instituted by Regulatory Agencies. In this white paper, we will focus on the reactions … Continued
Trial Simulator for NONMEM Modelers
Examples Guide Version 1 Applies to: Trial Simulator 2.3, NONMEM 7.3 As a courtesy to Certara’s Trial Simulator users, we have created this guide with 23 hypothetical examples where NONMEM codes and the corresponding TS codes are provided so that users may use these examples as templates to enter their models into Trial Simulator for … Continued
