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Key areas of focus include: Regulatory and Scientific Foundations: Current FDA scientific thinking on generic GLP-1 product development, Product-Specific Guidance (PSG) development, and in vivo BE studies for GLP-1 oral products Active Pharmaceutical Ingredient (API) Characterization and Manufacturing: Comprehensive approaches to demonstrating API sameness, analytical characterization strategies, impurity profiling, and sameness assessment for peptide products Recombinant Peptide Production: Best practices for controlling host cell impurities, regulatory expectations, and risk assessment strategies Oral GLP-1 Formulation Development: Formulation and delivery innovations, bioequivalence study design for highly variable products, absorption enhancement technologies, and drug product quality expectations Device User Interface and Human Factors: Comparative analyses (CA) of device user interfaces, Comparative Use Human Factors (CUHF) study design and case examples, alternative approaches, and device platform strategies Device Quality and Integration: Quality considerations for generic injectors, drug-device interface and compatibility, manufacturing quality control, and submission coordination strategies Join us for an immersive two-day experience featuring presentations from leading experts in regulatory agencies, pharmaceutical industry, and academia
F.BerdnikovsS.SimonH.-U.BochnerB
Yes, many patients self-administer Lipo-C after receiving proper training from their healthcare provider
Bathroom cabinets work if they stay dry and away from shower steam, but bedroom or kitchen storage at room temperature is safer
Although Botox and filler treatments are often mentioned together, they are completely not the same
