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Clinically-relevant dissolution specifications, implication for use in the post-approval setting & tension with F2 similarity testing
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Clinically-relevant dissolution specifications, implication for use in the post-approval setting & tension with F2 similarity testing
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Transforming promising molecules into valued medicines – the emerging Alderley Park Translational Science Ecosytem (APTrans)
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Design space considerations for dissolution methods
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Accelerating the development of drug products using advanced pharmaceutical design tools and manufacturing
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Pharmaceutical Quality: The dissolution test and clinically relevant specifications – impact on product development
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Clinically relevant specifications in practice: What have we learned since the QbD Pilot Program?
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Introduction to the Biopharmaceutics Risk Assessment Roadmap (BioRAM), Drug Delivery Scenarios and Scoring Grid
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Score sheet, Box 1: Early basic knowledge, starting point. From Blueprint to action: Getting to critical questions and knowledge.
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In silico modelling: Subcutaneous Bioavailability of mAbs
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Biopharmaceutics in Complex Parenteral Formulation Design
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Early understanding of PK/PD: setting up success in development?
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It’s never too early to put the patient first
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