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Harnessing the AI/ML in drug and biological products discovery and development: the regulatory perspective

Analytical method validation follows ICH guidelines with established specifications for key quality attributes

CONCLUSIONS CONFLICTS OF INTEREST In the last 5 years Adie Viljoen has received lecture honoraria and/or travel support and/or conducts clinical trials funded by: Amarin, Amgen, Astra Zeneca, Boehringer Ingleheim, Daiichi-Sankyo, Lilly, Menarini, NewAmsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Takeda, and Tosoh

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The Microdose GLP-1 Protocol ($129/month) addresses this challenge by starting at lower initial doses, reducing early gastrointestinal distress while still producing meaningful weight loss

Most people feel back to normal within 24 to 72 hours