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- Title
Challenges and opportunities in the design of age-appropriate drug products.
- Authors
Stegemann, S.
- Abstract
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.
- Subjects
MEDICAL care for older people; DRUG development; PHARMACEUTICAL industry; PRODUCT life cycle; PRODUCT life cycle assessment
- Publication
Zeitschrift für Gerontologie und Geriatrie, 2012, Vol 45, Issue 6, p479
- ISSN
0948-6704
- Publication type
Article
- DOI
10.1007/s00391-012-0361-z