Media Summary: This presentation explored general constraints in dry powder inhaler (DPI) formulation and manufacturing, while discussing ... This presentation provided an overview of the draft guidance on This presentation discussed the ANDA landscape for topical products applied to the skin and identified challenges associated ...
Agdd 2024 D2s02 Quality Considerations - Detailed Analysis & Overview
This presentation explored general constraints in dry powder inhaler (DPI) formulation and manufacturing, while discussing ... This presentation provided an overview of the draft guidance on This presentation discussed the ANDA landscape for topical products applied to the skin and identified challenges associated ... The second of three Q&A discussion panels from day two of the Advancing Generic Drug Development Conference. This presentation provided an overview of the current use of Comparative Use Human Factors (CUHF) studies to support various ... This presentation described content and format requirements for composition statements of drug products and explained what to ...
This presentation described different long-acting injectable (LAI) products and recognized regulatory and scientific challenges for ... This presentation discussed the complexity of generic oligonucleotides and RLD-equivalence This presentation described how ongoing research contributes to the evolution of Product-Specific Guidances (PSGs) for topical ... This presentation identified recent product-specific guidance (PSG) documents that include detailed language regarding the use ... This presentation explained factors that could impact first-cycle bioequivalence (BE) adequacy based on observed BE ... The first of three Q&A discussion panels from day two of the Advancing Generic Drug Development Conference.
This presentation discussed in silico methodologies for topical products applied to the skin, with particular focus on dermal ... The second of four Q&A discussion panels from day one of the Advancing Generic Drug Development Conference. Closing remarks from day two of the Advancing Generic Drug Development Conference delivered by Dr. Robert Lionberger. This presentation recognized the significant challenges associated with conducting comparative clinical endpoint (CCEP) ... This presentation explored the Generic Drug Science and Accessibility-Bioequivalence (GDSA-BE) initiative and its role in ... The final Q&A discussion panel from day two of the Advancing Generic Drug Development Conference. ***No Timestamps*** ...
This presentation addressed safety concern thresholds for extractables and leachables in ANDA submissions and covered ...
