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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. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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Bayer, Broad Institute Extend Cardiovascular Drug Research Pact

The Pharma Data

The expanded agreement, which now stretches the collaboration through at least 2028, marks a new chapter in the two organizations’ efforts to harness cutting-edge genomic research, high-throughput screening platforms, and translational science to deliver precision medicines that could alter the course of chronic cardiovascular diseases.

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Using clinical genomics and AI in drug development to elevate success

Drug Target Review

These hurdles not only delay patient access to innovative treatments but also threaten the economic sustainability of research and development (R&D) and the advancement of medical innovation. Addressing the long timelines and high costs of drug development is therefore critical for the advancement of medical innovation.