Media Summary: dissolution issues and examined OGD's bioequivalence evaluation based on the This presentation explained factors that could impact first-cycle bioequivalence (BE) adequacy based on observed BE ... This presentation examined In Vitro Release Testing (IVRT) for drug products containing nanomaterials, with a specific focus on ...
Agdd 2024 D2s05 1 Totality - Detailed Analysis & Overview
dissolution issues and examined OGD's bioequivalence evaluation based on the This presentation explained factors that could impact first-cycle bioequivalence (BE) adequacy based on observed BE ... This presentation examined In Vitro Release Testing (IVRT) for drug products containing nanomaterials, with a specific focus on ... This presentation identified recent product-specific guidance (PSG) documents that include detailed language regarding the use ... This presentation assessed Critical Quality Attributes (CQA) risks for oral solution and suspension products and described first ... The first of four Q&A discussion panels from day
This presentation provided an overview of the model-integrated evidence (MIE) industry meeting pilot program and shared what ... This presentation described content and format requirements for composition statements of drug products and explained what to ... This presentation provided an overview of the current use of Comparative Use Human Factors (CUHF) studies to support various ... The first of four Q&A discussion panels for day two of the Generic Drug Forum This presentation introduced the recent ICH M13A Guidance: Bioequivalence for Immediate-Release (IR) Solid Oral Dosage ... The first of three Q&A discussion panels from day two of the Advancing Generic Drug Development Conference.
This presentation described critical considerations for formulation development when a test product fails to meet the "no significant ... This presentation recognized the significant challenges associated with conducting comparative clinical endpoint (CCEP) ... This presentation discussed the ANDA landscape for topical products applied to the skin and identified challenges associated ... FDA experts demonstrate the FDA's Generic Drug User Fee Amendments (GDUFA) Science and Research Program's ... Closing remarks from day two of the Advancing Generic Drug Development Conference delivered by Dr. Robert Lionberger.
