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001-es BibID:	BIBFORM091566
035-os BibID:	(cikkazonosító)155
Első szerző:	Franco, Nuno Henrique
Cím:	Assessing Scientific Soundness and Translational Value of Animal Studies on DPP4 Inhibitors for Treating Type 2 Diabetes Mellitus / Nuno Henrique Franco, Sonia Miranda Batista, Nóra Kovács, Attila Csaba Nagy, Thiên, Bùi Quôc, Flávio Reis, Orsolya Varga
Dátum:	2021
ISSN:	2079-7737
Megjegyzések:	Although there is a wide range of animal models of type 2 diabetes mellitus (T2DM) used in re-search; we have limited evidence on their translation value. This paper provides a) a comparison of preclinical animal and clinical results on the effect of five dipeptidyl peptidase-4 (DPP4) in-hibitors by comparing the pharmaceutical caused glucose changes, and b) an evaluation of methodological and reporting standards in T2DM preclinical animal studies. DPP4 inhibitors play an important role in the clinical management of T2DM: if metformin alone is not sufficient enough to control the blood sugar levels, DPP4 inhibitors are often used as second-line therapy; additionally, DPP-4 inhibitors are also used in triple therapies with metformin and sodi-um-glucose co-transporter-2 (SGLT-2) inhibitors or with metformin and insulin. In our analysis of 124 preclinical studies and 47 clinical trials, (1) we found no evidence of species differences in glucose change response to DPP4 inhibitors, which may suggest that, for this drug class, studies in mice and rats may be equally predictive of how well a drug will work in humans; and (2) there is good reporting of group size, sex, age, euthanasia method and self-reported compliance with animal welfare regulations in animal studies but poor reporting of justification of group size, along with a strong bias towards the use of male animals and young animals. Instead of the common non-transparent model selection, we call for a reflective and evidenced-based assess-ment of predictive validity of the animal models currently available.
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Biology. - 10 : 2 (2021), p. 1-18. -
További szerzők:	Batista, Sonia Miranda Kovács Nóra (1989-) (népegészségügyi szakember) Nagy Attila Csaba (1981-) (megelőző orvostan és népegészségtan szakorvos, epidemiológus) Thiên, Bùi Quôc Reis, Flávio Varga Orsolya (1977-) (orvos, jogász)
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM087406
Első szerző:	Franco, Nuno Henrique
Cím:	Trends in animal model preference for preclinical drug testing for type-2 diabetes and future directions / Nuno Henrique Franco, Sónia Batista Miranda, Nora Kovacs, Attila Nagy, Folahanmi Tomiwa Akinsolu, I. Anna S. Olsson, Orsolya Varga
Dátum:	2020
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	bioRxiv. - 2020 (2020), p. 1-6. -
További szerzők:	Sónia, Batista Miranda Kovács Nóra (1989-) (népegészségügyi szakember) Nagy Attila Csaba (1981-) (megelőző orvostan és népegészségtan szakorvos, epidemiológus) Akinsolu, Folahanmi Tomiwa (1987-) Olsson, I. Anna Varga Orsolya (1977-) (orvos, jogász)
Pályázati támogatás:	TÉT_16-1-2016-0093 Egyéb
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM078829
035-os BibID:	(WOS)000423196400001 (PMID)29359995 (PMCID)PMC5987990
Első szerző:	Smith, David
Cím:	Classification and reporting of severity experienced by animals used in scientific procedures: FELASA/ECLAM/ESLAV Working Group report / David Smith, David Anderson, Anne-Dominique Degryse, Carla Bol, Ana Criado, Alessia Ferrara, Nuno Henrique Franco, István Gyertyán, Jose M. Orellana, Grete Ostergaard, Orsolya Varga, Hanna-Marja Voipio
Dátum:	2018
ISSN:	0023-6772
Megjegyzések:	Directive 2010/63/EU introduced requirements for the classification of the severity of procedures to be applied during the project authorisation process to use animals in scientific procedures and also to report actual severity experienced by each animal used in such procedures. These requirements offer opportunities during the design, conduct and reporting of procedures to consider the adverse effects of procedures and how these can be reduced to minimize the welfare consequences for the animals. Better recording and reporting of adverse effects should also help in highlighting priorities for refinement of future similar procedures and benchmarking good practice. Reporting of actual severity should help inform the public of the relative severity of different areas of scientific research and, over time, may show trends regarding refinement. Consistency of assignment of severity categories across Member States is a key requirement, particularly if re-use is considered, or the safeguard clause is to be invoked. The examples of severity classification given in Annex VIII are limited in number, and have little descriptive power to aid assignment. Additionally, the examples given often relate to the procedure and do not attempt to assess the outcome, such as adverse effects that may occur. The aim of this report is to deliver guidance on the assignment of severity, both prospectively and at the end of a procedure. A number of animal models, in current use, have been used to illustrate the severity assessment process from inception of the project, through monitoring during the course of the procedure to the final assessment of actual severity at the end of the procedure (Appendix 1).
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk severity humane end-point refinement ethics & welfare
Megjelenés:	Laboratory Animals. - 52 : suppl 1 (2018), p. 5-57. -
További szerzők:	Anderson, David Degryse, Anne-Dominique Bol, Carla Criado, Ana Ferrara, Alessia Franco, Nuno Henrique Gyertyán István Orellana, Jose M. Ostergaard, Grete Varga Orsolya (1977-) (orvos, jogász) Voipio, Hanna-Marja
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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