Blog Archives

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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…

CertaraOctober 6, 2023

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…

CertaraSeptember 29, 2023

Blog

What is Kanban and how does it optimize early drug discovery projects?

Discover how Kanban optimizes early drug discovery projects. Visualize workflow, improve collaboration, and increase productivity…

CertaraSeptember 27, 2023

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…

CertaraSeptember 21, 2023

Blog

Top Lessons Learned from 300 Regulatory Submissions

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

CertaraSeptember 20, 2023

Blog

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.…

CertaraSeptember 15, 2023

Blog

Methods to Increase Signal Finding in Rare Disease Drug Development

The regulatory landscape for drugs to treat rare diseases is being disrupted. Gleaning from several…

CertaraSeptember 8, 2023

Blog

Chemical Data Migration best practices – Stage 1: Project Planning and Data Assessment

Whitepaper on best business practices, for data migration

CertaraSeptember 4, 2023

Blog

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

On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (IRA) into…

CertaraAugust 25, 2023

Blog

Stop if you don’t have an unambiguous drug effect for your new molecular entity!

As a pharmacologist, I’ve always been curious about how drugs work. A favorite time-killer while…

CertaraAugust 18, 2023

Blog

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

Developing Pediatric PBPK Models for Differing Ethnic Populations

What is Kanban and how does it optimize early drug discovery projects?

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?

Methods to Increase Signal Finding in Rare Disease Drug Development

Chemical Data Migration best practices – Stage 1: Project Planning and Data Assessment

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

Stop if you don’t have an unambiguous drug effect for your new molecular entity!

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