On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
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 ...
Monday, October 21, 2024
FDA Office of Scientific Investigations (OSI) Requests for Bioresearch Monitoring (BIMO) Data for NDA/BLA Submission
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FDA has a Bioresearch Monitoring (BIMO) program and the BIMO program is managed by the Office of Scientific Investigations (OSI). BIMO pro...
Saturday, September 28, 2024
Crossover design in confirmatory therapeutic trials
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This week, FDA approved a new drug called Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pi...
Monday, September 23, 2024
The Role of Radiolabeling in Clinical Studies: Exploring Lung Deposition and Mass Balance Studies
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Radiolabeling is an advanced and valuable technique in clinical research that enables scientists to trace the journey of drugs through the h...
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