Blog Archives

Blog

Authoring & Assembling IND and CTA Applications – Insights and Updates

Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for…

Certara2023年10月23日

Blog

Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling

This blog explains how Certara’s Simcyp team developed and tested a model in the Simcyp…

Certara2023年10月20日

Blog

eCTD 4.0について知っておくべき10のこと：今後の規制当局への提出

In this blog post, we explore the top 10 things you need to know about…

Certara2023年10月17日

ブログ

Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers?

Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV…

Certara2023年10月6日

Blog

Developing Pediatric PBPK Models for Differing Ethnic Populations

Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because…

Certara2023年9月29日

Blog

Maximizing Reusability for Drug Submissions to Different Health Authorities

Many drug developers have products that they want to submit for marketing approval in several…

Certara2023年9月21日

Blog

Top Lessons Learned from 300 Regulatory Submissions

Who would have thought when we completed work on the first submission for which we…

Certara2023年9月20日

ブログ

What is ICER & How Does it Impact the Pharmaceutical Industry?

The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization.…

Certara2023年9月15日

Blog

希少疾患治療薬開発におけるシグナル検出を増加させる方法

希少疾患の治療薬に関する規制状況は大きく変化しています。Gleaning from several…

Certara2023年9月8日

Blog

Payers’ reaction to the IRA’s Medicare Part D Redesign

On 2022年8月16日, President Biden signed the Inflation Reduction Act of 2022 (IRA) into…

Certara2023年8月25日

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ブログ

Authoring & Assembling IND and CTA Applications – Insights and Updates

Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling

eCTD 4.0について知っておくべき10のこと：今後の規制当局への提出

Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers?

Developing Pediatric PBPK Models for Differing Ethnic Populations

Maximizing Reusability for Drug Submissions to Different Health Authorities

Top Lessons Learned from 300 Regulatory Submissions

What is ICER & How Does it Impact the Pharmaceutical Industry?

希少疾患治療薬開発におけるシグナル検出を増加させる方法

Payers’ reaction to the IRA’s Medicare Part D Redesign

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