Blog

PBPK modeling & simulation of therapeutic oligonucleotides from bench to bedside

Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage…

Certara2022 年 10 月 14 日

Fact Sheet

PK Submit™ 概览

了解 PK Submit™ 如何加速 NCA 工作流并确保符合监管要求

Certara2022 年 10 月 12 日

Announcement

Certara Announces New Release of PK Submit

PRINCETON, N.J.— 2022 年 10 月 12 日 – Certara, Inc., a global leader in drug development software,…

Certara2022 年 10 月 12 日

On-Demand Webinar

How to Define & Measure Clinical Endpoints to Optimize Your Oncology Drug Dosing

Historically, the dosing strategy for oncology drugs focused on the maximum tolerated dose. This has…

Certara2022 年 10 月 5 日

Blog

Choosing a clinical trial transparency and disclosure vendor: Your complete checklist

Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D)…

Certara2022 年 10 月 4 日

Blog

5 steps to satisfy new EU-CTR requirements for plain language summaries of clinical study results

For the first time, the European Medicines Agency (EMA) has passed new regulations to help…

Certara2022 年 9 月 27 日

Business transparency, integrity or data disclosure concept, businessman standing with disclosure financial document in crystal clear fish bowl

Blog

EU-CTR challenges drug developers faced in the first 6 months

Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive…

Certara2022 年 9 月 26 日

Podcast

Certara – Improving Investment in Drug Development through Biosimulation

Certara2022 年 9 月 23 日

On-Demand Webinar

Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA)

Properly understanding the probability of successful drug development requires utilization of all available information. Critical…

Certara2022 年 9 月 23 日

Blog

3 takeaways from the FDA oligo guidance you need to know

In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…

Certara2022 年 9 月 23 日

pre-update

PBPK modeling & simulation of therapeutic oligonucleotides from bench to bedside

PK Submit™ 概览

Certara Announces New Release of PK Submit

How to Define & Measure Clinical Endpoints to Optimize Your Oncology Drug Dosing

Choosing a clinical trial transparency and disclosure vendor: Your complete checklist

5 steps to satisfy new EU-CTR requirements for plain language summaries of clinical study results

EU-CTR challenges drug developers faced in the first 6 months

Certara – Improving Investment in Drug Development through Biosimulation

Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA)

3 takeaways from the FDA oligo guidance you need to know

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