Detalhe da pesquisa
1.
Patient-reported, observer-reported and performance outcomes in qualification procedures at the European Medicines Agency 2013-2018.
Br J Clin Pharmacol
; 90(1): 299-312, 2024 01.
Artigo
Inglês
| MEDLINE | ID: mdl-37697483
2.
Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population.
Br J Clin Pharmacol
; 88(4): 1500-1514, 2022 02.
Artigo
Inglês
| MEDLINE | ID: mdl-35141926
3.
Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults.
Aging Clin Exp Res
; 33(1): 3-17, 2021 Jan.
Artigo
Inglês
| MEDLINE | ID: mdl-32737844
4.
Medication use among older people in Europe: Implications for regulatory assessment and co-prescription of new medicines.
Br J Clin Pharmacol
; 86(10): 1912-1920, 2020 10.
Artigo
Inglês
| MEDLINE | ID: mdl-32644249
5.
Sarcopenia in daily practice: assessment and management.
BMC Geriatr
; 16(1): 170, 2016 10 05.
Artigo
Inglês
| MEDLINE | ID: mdl-27716195
6.
New harmonized considerations on the evaluation instruments for baseline characterization of frailty in the European Union.
Br J Clin Pharmacol
; 2019 Jul 05.
Artigo
Inglês
| MEDLINE | ID: mdl-31276597
7.
Medicines for an aging population: The EMA perspective and policies.
J Am Geriatr Soc
; 2024 May 17.
Artigo
Inglês
| MEDLINE | ID: mdl-38757979
8.
Assessing Medicines for Use in the Geriatric Population.
Clin Pharmacol Ther
; 113(3): 536-540, 2023 03.
Artigo
Inglês
| MEDLINE | ID: mdl-36354419
9.
Evolving regulatory perspectives on digital health technologies for medicinal product development.
NPJ Digit Med
; 6(1): 56, 2023 Mar 29.
Artigo
Inglês
| MEDLINE | ID: mdl-36991116
10.
Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults.
Lancet Healthy Longev
; 4(12): e724-e729, 2023 12.
Artigo
Inglês
| MEDLINE | ID: mdl-37977177
11.
Roadmap to 2030 for Drug Evaluation in Older Adults.
Clin Pharmacol Ther
; 112(2): 210-223, 2022 08.
Artigo
Inglês
| MEDLINE | ID: mdl-34656074
12.
First Regulatory Qualification of a Novel Digital Endpoint in Duchenne Muscular Dystrophy: A Multi-Stakeholder Perspective on the Impact for Patients and for Drug Development in Neuromuscular Diseases.
Digit Biomark
; 5(2): 183-190, 2021.
Artigo
Inglês
| MEDLINE | ID: mdl-34723071
13.
Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy.
N Engl J Med
; 367(21): 1972-4, 2012 Nov 22.
Artigo
Inglês
| MEDLINE | ID: mdl-23171092
14.
Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?
Clin Pharmacol Ther
; 105(5): 1148-1155, 2019 05.
Artigo
Inglês
| MEDLINE | ID: mdl-29901216
15.
Medicines for older people: assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products.
Eur Geriatr Med
; 9(4): 415-418, 2018 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-34674494
16.
Pitfalls in the measurement of muscle mass: a need for a reference standard.
J Cachexia Sarcopenia Muscle
; 9(2): 269-278, 2018 04.
Artigo
Inglês
| MEDLINE | ID: mdl-29349935
17.
The authors reply: Letter on: "Pitfalls in the measurement of muscle mass: a need for a reference standard" by Clark et al.
J Cachexia Sarcopenia Muscle
; 9(7): 1272-1274, 2018 12.
Artigo
Inglês
| MEDLINE | ID: mdl-30697981
18.
Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.
Int J Pharm
; 512(2): 343-351, 2016 Oct 30.
Artigo
Inglês
| MEDLINE | ID: mdl-27150947
19.
Digital technologies for medicines: shaping a framework for success.
Nat Rev Drug Discov
; 19(9): 573-574, 2020 09.
Artigo
Inglês
| MEDLINE | ID: mdl-32398879
20.
The evolution of adaptiveness: balancing speed and evidence.
Nat Rev Drug Discov
; 17(12): 845-846, 2018 12.
Artigo
Inglês
| MEDLINE | ID: mdl-29977052