Quick Overview: This presentation discussed in silico methodologies for topical products applied to the skin, with particular focus on dermal ... This presentation described different long-acting injectable (LAI) products and recognized regulatory and scientific challenges for ... This presentation provided an overview of the current use of Comparative Use Human Factors (CUHF) studies to support various ...
Agdd 2024 D1s07 Enhanced Understanding - Detailed Overview & Context
This presentation discussed in silico methodologies for topical products applied to the skin, with particular focus on dermal ... This presentation described different long-acting injectable (LAI) products and recognized regulatory and scientific challenges for ... This presentation provided an overview of the current use of Comparative Use Human Factors (CUHF) studies to support various ... FDA experts demonstrate the FDA's Generic Drug User Fee Amendments (GDUFA) Science and Research Program's ... This presentation identified recent product-specific guidance (PSG) documents that include detailed language regarding the use ... This presentation discussed the ANDA landscape for topical products applied to the skin and identified challenges associated ...
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 content and format requirements for composition statements of drug products and dissolution issues and examined OGD's bioequivalence evaluation based on the totality of evidence for this case. The session ... This presentation described critical considerations for formulation development when a test product fails to meet the "no significant ... This presentation provided key principles for comparative analyses (CA) and established
This presentation discussed the complexity of generic oligonucleotides and RLD-equivalence considerations, while reviewing key ... This presentation described how ongoing research contributes to the evolution of Product-Specific Guidances (PSGs) for topical ... Closing remarks from day two of the Advancing Generic Drug Development Conference delivered by Dr. Robert Lionberger. This presentation provided an overview of the M13 guideline series and the final M13A guideline, highlighting major changes ... The first of four Q&A discussion panels from day one of the Advancing Generic Drug Development Conference. The second of four Q&A discussion panels from day one of the Advancing Generic Drug Development Conference.
