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The regulatory framework anchored by FDAs 2003 BA/BE guidance and 2002 CMC guidance, and USP General Chapter defines precise measurement requirements, lifestage sampling protocols, and statistical approaches for both brand-name NDA and generic ANDA development programs

These shifts in glutamate pools could be achieved without increasing oxidative stress or cell death

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10 Challenges in clinical translation and prospects for personalized therapy 10.1 Biomarker-driven patient stratification Currently, the diagnosis of tinnitus relies almost entirely on subjective self-report, as no objective biomarker has been validated for clinical diagnosis or patient stratification

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