The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Cytel

OCTOBER 27, 2023

Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. With consensus of multiple stakeholders on “why” the change is needed, the speakers focused on “how.”

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Drug Target Review

MAY 7, 2024

How do AI-enhanced approaches accelerate the drug development process for rare diseases? AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study.

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