Stegemann S
Capsugel, Rijksweg 11, 2880, Bornem, Belgium.
Z Gerontol Geriatr. 2012 Aug;45(6):479-84. doi: 10.1007/s00391-012-0361-z.
The age appropriateness of a pharmaceutical product for older patient populations is most important in achieving ease of use, administration, and adherence as well as the therapeutic benefit of the drug. Drug development is a lengthy and risky investment accompanied by extensive regulatory requirements to meet all the safety, efficacy, and quality criteria of a pharmaceutical product. Older adults represent a very heterogeneous patient population with different needs compared to younger adults. Major areas that should be considered in the design of age-appropriate products (AAP) are age- and disease-related aspects such as (a) different dose strengths, (b) issues in handling, administering, and managing the drug product, (c) and complex medication regimens. The application of different technologies can meet these specific needs and should be considered at the very beginning of product development when setting the targeted quality product profile (TQPP) or later on during the product life-cycle management.
对于老年患者群体而言，药品的年龄适宜性对于实现易用性、给药便利性、依从性以及药物的治疗益处最为重要。药物研发是一项漫长且具有风险的投资，伴随着广泛的监管要求，以满足药品的所有安全性、有效性和质量标准。与年轻人相比，老年人是一个需求各异的非常多样化的患者群体。在设计适合不同年龄的产品（AAP）时应考虑的主要领域包括与年龄和疾病相关的方面，例如（a）不同的剂量强度，（b）药品处理、给药和管理方面的问题，（c）以及复杂的用药方案。应用不同技术可以满足这些特定需求，并且在设定目标质量产品概况（TQPP）时的产品开发之初或在产品生命周期管理的后期都应予以考虑。
