title: Regulatory development of geriatric medicines: To GIP or not to GIP?
abstract: Geriatric patients represent the main users of medicines, but are historically often minimally included in clinical trials, resulting in a gap in the knowledge of the benefit/risk balance of medicines in this heterogeneous population. As the worldwide population is aging, the need for safe and effective medicines for older patients is proportionally increasing. The aim of this review is to provide an overview of the current regulatory status of the development of geriatric medicines, the encountered challenges and the view of the involved stakeholders, coming to the conclusion whether it is necessary or not to implement a Geriatric Investigation Plan (GIP), by analogy with pediatrics.
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Bart.DeSpiegeleer@UGent.be.
authors.forename: Bart
authors.initials: B
authors.lastname: De Spiegeleer
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Ejwynend.Wynendaele@UGent.be.
authors.forename: Evelien
authors.initials: E
authors.lastname: Wynendaele
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Nathalie.Bracke@UGent.be.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Bracke
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Lieselotte.Veryser@UGent.be.
authors.forename: Lieselotte
authors.initials: L
authors.lastname: Veryser
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Lien.Taevernier@UGent.be.
authors.forename: Lien
authors.initials: L
authors.lastname: Taevernier
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Agnes.Degroote@ADGConsultancy.be.
authors.forename: Agnes
authors.initials: A
authors.lastname: Degroote
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Postal address: Ottergemsesteenweg 460 (second floor), B-9000 Ghent, Belgium. Electronic address: Sofie.Stalmans@UGent.be.
authors.forename: Sofie
authors.initials: S
authors.lastname: Stalmans
mesh_terms: D000375:Aging / Q000502:physiology; D035843:Biomedical Research / Q000941:ethics / Q000379:methods; D005853:Geriatrics / Q000941:ethics / Q000458:organization & administration; D006801:Humans; D018579:Patient Selection / Q000941:ethics; D020379:Risk Adjustment; D012926:Social Control, Formal
keywords: Aging; Clinical trials; Drug development; Drug formulation; Geriatric; Regulatory affairs