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
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
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
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking
This webinar was presented on 2021 年 6 月 30 日 by David R. Taft, Ph.D. Professor, Pharmaceutics,…
Certara2021 年 7 月 26 日
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…
Certara2021 年 7 月 15 日
Three Pathways have emerged in Innovative Access Agreements
The days of simply determining the market demand for a new drug as a function…
Certara2021 年 6 月 11 日
Outcomes Based Agreements
The days of simply determining the market demand for a new drug as a function…
Certara2021 年 6 月 11 日
De-risk your program with evidence-based secondary pharmacology insights
Safety issues account for about a quarter of the attrition in drug projects and can…
Certara2021 年 5 月 28 日
Stakeholder perspectives: current and potential benefits
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…
Certara2021 年 5 月 26 日
Strengths and opportunities for HTAs and market access in Europe through case studies
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…
Certara2021 年 5 月 26 日
