On-Demand Webinar Archives

On-Demand Webinar

PBPK 模型在预测药物相互作用（DDIs）及吸烟和器官损伤影响方面的战略应用

Olanzapine is a highly effective antipsychotic, but its uses are limited by the risk of…

Certara2021 年 12 月 23 日

On-Demand Webinar

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…

Certara2021 年 12 月 16 日

On-Demand Webinar

预测和驯化免疫原性：生物药物策略

Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to…

Certara2021 年 11 月 19 日

On-Demand Webinar

外部对照臂 - 标准化词典和工具包的理由

Both the FDA and EMA have made statements that support the concept of using real…

Certara2021 年 10 月 12 日

On-Demand Webinar

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2…

Certara2021 年 10 月 7 日

On-Demand Webinar

美国食品药品监督管理局数字转型：技术的未来以及如何准备

As Life-Science manufacturers embrace new technologies to speed time to market and products become more…

Certara2021 年 10 月 5 日

On-Demand Webinar

罕见病管理的“可怕”未来

In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…

Certara2021 年 9 月 23 日

On-Demand Webinar

Preparing Vaccine Studies for Regulatory Submissions

In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…

Certara2021 年 9 月 10 日

网络研讨会点播

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…

Certara2021 年 9 月 10 日

网络研讨会点播

生物制剂的临床药理计划是怎样的？

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…

Certara2021 年 8 月 6 日

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网络研讨会点播

PBPK 模型在预测药物相互作用（DDIs）及吸烟和器官损伤影响方面的战略应用

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

预测和驯化免疫原性：生物药物策略

外部对照臂 - 标准化词典和工具包的理由

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

美国食品药品监督管理局数字转型：技术的未来以及如何准备

罕见病管理的“可怕”未来

Preparing Vaccine Studies for Regulatory Submissions

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

生物制剂的临床药理计划是怎样的？

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