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Clinical-Pharmacology-graph_Large-molecule_web

Alta Sciences

Clinical-Pharmacology-graph_Large-molecule_web ehdem Tue, 01/23/2024 - 14:06 Image Clinical-Pharmacology-graph_Large-molecule_web.png Weight 1

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Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Fierce BioTech

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Listing Image Certara-LogoListing-12052023.png

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Clinical Pharmacology Considerations for Peptide Drug Products

thought leadership

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category.

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Preparing the next generation of drug discovery scientists

Drug Discovery World

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. Due to this approach, the Clinical Pharmacology degree has various features that make it different to other courses that are currently available. Starting with the drug.

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What recent paediatric guidelines mean for drug developers 

Drug Discovery World

General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.

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Translating complex data into actionable insights, to create big value for smaller biotech companies

BioPharma Drive: Drug Pricing

Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.

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Antibody for gastric cancer progresses to Phase III trials

Drug Discovery World

The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. “We are delighted with the positive outcome of the EOP2 meeting,” said Dr Caroline Germa, Transcenta Executive Vice President, Global Medicine Development and Chief Medical Officer.

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