Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.

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Drug Discovery World

NOVEMBER 29, 2022

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. The curriculum and assessment structure is based on what the students will need to thrive in the drug development sector, with all scientific topics taught with the drug in mind first.

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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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Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Watch the video. Listen here. Watch it now.

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Agency IQ

JULY 28, 2023

This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g., FDA’s 2020 draft guidance discusses PBPK analyses for oral drug product development. Read the full AgencyIQ analysis here.

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Agency IQ

DECEMBER 1, 2023

As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations. drug-drug interactions) and intrinsic factors (e.g.,

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Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied. About Ischemix, Inc.

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