by Masatoshi Nakamura, Remi Onuma, Ryosuke Kiyono, Koki Yasaka, Shigeru Sato, (Aug,2018)
DOI: 10.4236/abb.2018.99028
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Here is a striking example of how we found key information in a very small population and successfully validated it on a much larger scale. By analyzing a few cases in selected small cities in Brazil, we unearthed crucial associations between diagnoses and operations in Brazil as a whole.
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From Aducanumab to Tofersen, a tale of clinical development and regulatory discussions based on the power of surrogate endpoints. Two years ago1, on June 7, 2021, the FDA announced the approval of the Biogen therapy aducanumab for the treatment of Alzheimer’s disease.
What does the FDA expect in 2023 for the submission of pharmacogenomic data as part of INDs or NDAs? In 2023, DNA chips have been replaced by DNA and RNA sequencing. In 2023, drug metabolizing enzyme pharmacogenomics now coexist with pharmacogenomic biomarkers across clinical areas, diseases, therapies and platforms.