4.7 Article

Patient-centric drug product development: Acceptability across patient populations-Science and evidence

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ELSEVIER
DOI: 10.1016/j.ejpb.2023.04.017

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Acceptability; Patient -centric; Methodology; Drug product design; Reimbursement; Regulation; Patient engagement

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The 6th APV Winter Conference, organized by the APV PaCeMe IN Task Force, was held in Salzburg, Austria from January 19-20, 2023. The conference was dedicated to advancing patient-centric drug development, considering emerging evidence and increasing regulatory requirements.
The 6th APV (Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnologie e.V., The International Associa-tion for Pharmaceutical Technology) Winter Conference took place in Salzburg (Austria) from January 19-20, 2023. This conference was dedicated to advance patient-centric drug development across all dosage forms, in-dications and patient populations and was organized by the APV PaCeMe IN Task Force. The topic was chosen due to emerging evidence and increasing regulatory requirements to consider patient needs and capabilities in drug product development. It is well acknowledged that acceptability of a drug product and its dosage form is a fundamental aspect of patient centric drug product design which can directly impact adherence and intended use, hence effectiveness and safety. Despite the requirement to proof acceptability within the drug development program, respective methods to determine and compare the degree of acceptability of different dosage forms and drug product designs are still limited.

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