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Development of geriatric medicines: to GIP or not to GIP?

Sofie Stalmans (UGent) , Nathalie Bracke (UGent) and Bart De Spiegeleer (UGent)
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Abstract
The elderly population represents a heterogeneous group of patients, which show co-morbidities and is often poly-medicated. Although geriatric patients form the main users of medicines, this group is underrepresented in clinical trials. Safe and efficacious use of drugs by this group is often not ensured. However, since these elderly population will numerically expand in the coming years, this patient group can no longer be neglected during the development and approval stage of medicines. We evaluated the current regulatory status for the geriatric medicines. Next, the views of the different stakeholders in this field will be analyzed. Finally, points of attention and suggestions concerning this regulatory discussion will be emphasized, like i.a. the approach of personalized medicine, the age and disease-related change in blood-brain barrier permeability and use of predictive models. Thus, by analogy with the paediatric investigation plan (PIP), coming to the conclusion whether to GIP or not to GIP?
Keywords
Geriatric medicines, regulatory affairs, clinical trials, drug development

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Chicago
Stalmans, Sofie, Nathalie Bracke, and Bart De Spiegeleer. 2014. “Development of Geriatric Medicines: To GIP or Not to GIP?” In TOPRA, 11th Annual Symposium, Abstracts. London, UK: The Organisation for Professionals in Regulatory Affairs (TOPRA).
APA
Stalmans, S., Bracke, N., & De Spiegeleer, B. (2014). Development of geriatric medicines: to GIP or not to GIP? TOPRA, 11th Annual symposium, Abstracts. Presented at the 11th TOPRA Annual symposium, London, UK: The Organisation for Professionals in Regulatory Affairs (TOPRA).
Vancouver
1.
Stalmans S, Bracke N, De Spiegeleer B. Development of geriatric medicines: to GIP or not to GIP? TOPRA, 11th Annual symposium, Abstracts. London, UK: The Organisation for Professionals in Regulatory Affairs (TOPRA); 2014.
MLA
Stalmans, Sofie, Nathalie Bracke, and Bart De Spiegeleer. “Development of Geriatric Medicines: To GIP or Not to GIP?” TOPRA, 11th Annual Symposium, Abstracts. London, UK: The Organisation for Professionals in Regulatory Affairs (TOPRA), 2014. Print.
@inproceedings{5730679,
  abstract     = {The elderly population represents a heterogeneous group of patients, which show co-morbidities and is often poly-medicated. Although geriatric patients form the main users of medicines, this group is underrepresented in clinical trials. Safe and efficacious use of drugs by this group is often not ensured. However, since these elderly population will numerically expand in the coming years, this patient group can no longer be neglected during the development and approval stage of medicines. 
We evaluated the current regulatory status for the geriatric medicines. Next, the views of the different stakeholders in this field will be analyzed. Finally, points of attention and suggestions concerning this regulatory discussion will be emphasized, like i.a. the approach of personalized medicine, the age and disease-related change in blood-brain barrier permeability and use of predictive models. Thus, by analogy with the paediatric investigation plan (PIP), coming to the conclusion whether to GIP or not to GIP?},
  author       = {Stalmans, Sofie and Bracke, Nathalie and De Spiegeleer, Bart},
  booktitle    = {TOPRA, 11th Annual symposium, Abstracts},
  keywords     = {Geriatric medicines,regulatory affairs,clinical trials,drug development},
  language     = {eng},
  location     = {Brussels, Belgium},
  publisher    = {The Organisation for Professionals in Regulatory Affairs (TOPRA)},
  title        = {Development of geriatric medicines: to GIP or not to GIP?},
  year         = {2014},
}