These hormones are released by the gut in response to food intake and play crucial roles in glucose regulation
HunterKHlscherC
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
Nasteska, D
Right upper abdominal pain particularly after meals suggests possible gallbladder problems
That clinical evidence doesn't automatically transfer to compounded preparations, which haven't been separately studied as finished products
