Why Should Academia Care About the Target Product Profile?

Overview

Journal J Transl Med

Publisher Biomed Central

Specialties Biomedical Engineering
General Medicine

Date 2024 Aug 2

PMID 39095839

Authors

Marina Boccardi

Michael Gold

Vijay Mahant

Francesco M Marincola

Angus Gunn

Affiliations

Soon will be listed here.

References

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Boccardi M . Translational process. J Transl Med. 2023; 21(1):677. PMC: 10540412. DOI: 10.1186/s12967-023-04507-7. View

Boccardi M, Festari C, Altomare D, Gandolfo F, Orini S, Nobili F . Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia. Eur J Nucl Med Mol Imaging. 2018; 45(9):1470-1486. DOI: 10.1007/s00259-018-4024-1. View

Cocco P, Ayaz-Shah A, Messenger M, West R, Shinkins B . Target Product Profiles for medical tests: a systematic review of current methods. BMC Med. 2020; 18(1):119. PMC: 7212678. DOI: 10.1186/s12916-020-01582-1. View

Ramusino M, Perini G, Altomare D, Barbarino P, Weidner W, Salvini Porro G . Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives. Eur J Nucl Med Mol Imaging. 2021; 48(7):2157-2168. PMC: 8175294. DOI: 10.1007/s00259-020-05187-x. View

Boccardi M, Dodich A, Albanese E, Gayet-Ageron A, Festari C, Ashton N . The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update. Eur J Nucl Med Mol Imaging. 2021; 48(7):2070-2085. PMC: 8175304. DOI: 10.1007/s00259-020-05120-2. View

Frisoni G, Boccardi M, Barkhof F, Blennow K, Cappa S, Chiotis K . Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers. Lancet Neurol. 2017; 16(8):661-676. DOI: 10.1016/S1474-4422(17)30159-X. View

10.

Bakker E, Hendrikse N, Ehmann F, van der Meer D, Llinares Garcia J, Vetter T . Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020. Clin Pharmacol Ther. 2022; 112(1):69-80. PMC: 9313861. DOI: 10.1002/cpt.2554. View