Monday, January 13, 2025

Prognostic enrichment versus predictive enrichment

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Prognostic enrichment and predictive enrichment are both strategies used in clinical trials to select patients for inclusion. Both strategie...
Sunday, January 12, 2025

Survivorship Bias and its Occurrences in Clinical Trials

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Survivorship bias or survival bias is the logical error of concentrating on entities that passed a selection process while overlooking thos...
Sunday, December 29, 2024

Bioethics with Biotechnology, Bioengineering, and Genetic Engineering

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Biotechnology and bioengineering are advancing at an unprecedented pace. Through genetic engineering, possibilities once considered unthinka...
Saturday, December 28, 2024

Known knowns and Unknown Unknowns

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On several occasions during scientific presentations, I have come across citations of Donald Rumsfeld's statement. Donald Rumsfeld was o...
Friday, November 29, 2024

Real world data (RWD) and Real world evidence (RWE) in Drug Development

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The 21st Century Cures Act (Cures Act) , signed into law on December 13, 2016, is designed to accelerate medical product development and bri...
Friday, November 01, 2024

Comparing "In Vitro," "In Vivo," "Clinical Trial," and "In Silico": Understanding Research Approaches in Science

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Scientific research relies on diverse methods to study complex biological systems, test hypotheses, and develop treatments. Four commonly us...
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Sunday, October 27, 2024

US Approved Gene Therapies and Summary Basis for Approvals

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The FDA presentation by Dr Gopa Raychaudhuri, "Facilitating Development of Gene Therapies for Rare Diseases," summarized all Gene ...