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- FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trialsIndustry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
- New name for PCOS aims to boost awareness and diagnosis for Black and Latina womenBontle Moka-Moliki, a 32-year-old from Atlanta, was diagnosed with endometriosis in 2019, fibroids a year later, and in 2024 received a diagnosis of a condition now called polyendocrine metabolic o…