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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

Strengthening logistical capabilities One of the most unnecessary clinical trial burdens can be site inefficiencies, particularly where sites exist that do not recruit. He received an MD from the Georg August University of Göttingen and completed a postdoctoral Master’s in Medical Sciences Clinical Pharmacology at the University of Glasgow.

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NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

Putting Patients First Blog

This includes being aware of historical injustices that may have contributed to mistrust in the medical system and understanding the unique needs and concerns of different communities. Effective communication with diverse populations is essential for ensuring that all individuals can participate in clinical trials. and Zhang, L.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

Ratain says achieving the right dosage requires an understanding of clinical pharmacology and a randomised trial. The clinical pharmacology knowledge also isn’t present at smaller companies, he adds. The MTD model made sense for early cancer studies when most drugs had non-specific targets, says Veal.

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FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

FDA Law Blog: Biosimilars

The Guidance provides a listing of domains for such assessment as pertains to general concerns ( e.g. , quality of life, physical health) and neurodevelopmental concerns ( e.g. , sensory, motor, cognition, communication). The Guidance is written carefully to communicate that these determinations are all very case-specific.