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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. As a result, we ensure collection of all urine and fecal samples over a period ranging between five to seven days, modifying the participant diet if needed.

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Pediatric Development Plans: Key Considerations

Cytel

Historically, many drugs have been prescribed to children even though this patient population have largely been excluded from clinical trials. There is an obvious logic. If medicines are to be used in children, they need to be studied in pediatric populations to ensure they are safe and effective.

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Innovation Drives Excellence, Innovent Successfully Held 2020 Virtual R&D Day

The Pharma Data

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. Michael Yu reviewed the history and achievements in the past nine years since the establishment of Innovent.

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Bayer, Broad Institute Extend Cardiovascular Drug Research Pact

The Pharma Data

The Broad Institute, one of the world’s leading biomedical research centers, brings deep capabilities in genomics, systems biology, and computational analytics. Bayer contributes decades of experience in pharmaceutical R&D, encompassing drug design, medicinal chemistry, and clinical development for both small molecules and biologics.

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Using clinical genomics and AI in drug development to elevate success

Drug Target Review

Addressing the long timelines and high costs of drug development is therefore critical for the advancement of medical innovation. Unfortunately, many drug candidates fail. Clinical development failure may be due to an inability to demonstrate efficacy or sufficient safety. Unfortunately, many drug candidates fail.