Leibniz JointLab First in Translation, Forckenbeckstrasse 50, 52074 Aachen, Germany.
University Hospital Düsseldorf, Department of General Paediatrics, Neonatology and Paediatric Cardiology , Moorenstrasse 5, 40225 Düsseldorf, Germany.
Eur J Pharm Biopharm. 2023 Jul;188:1-5. doi: 10.1016/j.ejpb.2023.04.017. Epub 2023 May 8.
The 6th APV (Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnologie e.V., The International Association 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, indications 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.
第六届 APV（Pharmazeutische Verfahrenstechnologie e.V.，国际制药技术协会）冬季会议于 2023 年 1 月 19 日至 20 日在奥地利萨尔茨堡举行。本次会议的主题是推进所有剂型、适应症和患者群体的以患者为中心的药物开发，由 APV PaCeMe IN 工作组组织。选择这个主题是因为有新的证据和不断增加的监管要求，需要在药物产品开发中考虑患者的需求和能力。人们普遍认识到，药物产品及其剂型的可接受性是药物产品设计以患者为中心的一个基本方面，它可以直接影响到药物的依从性和预期用途，从而影响药物的有效性和安全性。尽管在药物开发计划中需要证明可接受性，但确定和比较不同剂型和药物产品设计的可接受性程度的相应方法仍然有限。
