Quick Overview: This presentation discussed the complexity of This presentation provided an overview of the model-integrated evidence (MIE) industry meeting pilot program and shared what ... This presentation provided an overview of the current use of Comparative Use Human Factors (CUHF) studies to support various ...
Agdd 2024 D2s06 Emerging Generic - Detailed Overview & Context
This presentation discussed the complexity of This presentation provided an overview of the model-integrated evidence (MIE) industry meeting pilot program and shared what ... This presentation provided an overview of the current use of Comparative Use Human Factors (CUHF) studies to support various ... This presentation assessed Critical Quality Attributes (CQA) risks for oral solution and suspension products and described first ... This presentation recognized the significant challenges associated with conducting comparative clinical endpoint (CCEP) ... This presentation described different long-acting injectable (LAI) products and recognized regulatory and scientific challenges for ...
This presentation described content and format requirements for composition statements of drug products and explained what to ... This presentation provided key principles for comparative analyses (CA) and established understanding of essential CA ... This presentation examined In Vitro Release Testing (IVRT) for drug products containing nanomaterials, with a specific focus on ... Closing remarks from day two of the Advancing This presentation explored the critical need for improved In Vitro Release Testing (IVRT) methods for complex drug products. This presentation described critical considerations for formulation development when a test product fails to meet the "no significant ...
This presentation addressed nitrosamine formation and their presence in drug products, referencing relevant FDA guidances. Dr. John Arigo, Director of the Division of Pharmaceutical Manufacturing Assessment II in the Office of Pharmaceutical ... This presentation discussed in silico methodologies for topical products applied to the skin, with particular focus on dermal ... This presentation identified recent product-specific guidance (PSG) documents that include detailed language regarding the use ... This presentation described how ongoing research contributes to the evolution of Product-Specific Guidances (PSGs) for topical ... Closing remarks from day one of the Advancing
