Use of In Silico Methods for Regulatory Toxicological Assessment of Pharmaceutical Impurities

Autor: Simona, Kovarich, Claudia Ileana, Cappelli

Publikováno v: Methods in molecular biology (Clifton, N.J.). 2425

The use of novel non-testing methodologies to support the toxicological assessment of drug impurities is having a growing impact in the regulatory framework for pharmaceutical development and marketed products. For DNA reactive (mutagenic) impurities

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::62d6cef0519a62c532ab8b0af7edaea3
https://pubmed.ncbi.nlm.nih.gov/35188646

Ranking strategies to support toxicity prediction: A case study on potential LXR binders

Autor: Simona Kovarich, Arianna Bassan, Elena Fioravanzo, Anna Palczewska, Andrea Ciacci, Daniel Neagu

Publikováno v: Computational Toxicology. 10:130-144

The current paradigm of toxicity testing is set within a framework of Mode-of-Action (MoA)/Adverse Outcome Pathway (AOP) investigations, where novel methodologies alternative to animal testing play a crucial role, and allow to consider causal links b

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a84150495604bfe517c7cacc27b44f79
https://doi.org/10.1016/j.comtox.2019.01.004

Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology

Autor: Grace Patlewicz, Matthias Herzler, Manuela Pavan, Marcel Leist, Thomas Hartung, Tara S. Barton-Maclaren, Susanne Hougaard Bennekou, Kerry Nugent, Simona Kovarich, Alexandra Maertens, P. Charukeshi Chandrasekera, Bruno Hubesch, Joop de Knecht, Nicole Kleinstreuer, Francesca Caloni, Lena Smirnova, Sylvia Escher, Mark T. D. Cronin, Emilio Benfenati, Giorgia Pallocca, Jaffar Kisitu, Manuel Pastor, Christophe Chesne, Hennicke Kamp, Michael Schwarz, Suzanne Fitzpatrick, Octavio Augusto França Presgrave, Daniel R. Dietrich, Takashi Yamada, Costanza Rovida, Brenna M. Flannery

Publikováno v: ALTEX
Rovida, C, Barton-Maclaren, T, Benfenati, E, Caloni, F, Chandrasekera, C, Chesne, C, Cronin, M T D, De Knecht, J, Dietrich, D R, Escher, S E, Fitzpatrick, S, Flannery, B, Herzler, M, Hougaard Bennekou, S, Hubesch, B, Kamp, H, Kisitu, J, Kleinstreuer, N, Kovarich, S, Leist, M, Maertens, A, Nugent, K, Pallocca, G, Pastor, M, Patlewicz, G, Pavan, M, Presgrave, O, Smirnova, L, Schwarz, M, Yamada, T & Hartung, T 2020, ' Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology ', A L T E X. Alternatives to Animal Experimentation, vol. 37, no. 4, pp. 579-606 . https://doi.org/10.14573/altex.1912181

Read-across (RAx) translates available information from well-characterized chemicals tothe substance for which there is a toxicological data gap. The OECD is working on case studies to probe general applicability of RAx, and several regulations (e.g.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1f413a6eb232a2dee4050c887892ba5a
https://pubmed.ncbi.nlm.nih.gov/32369604

Filling Data Gaps by Read-across: A Mini Review on its Application, Developments and Challenges

Autor: Lidia Ceriani, Manuela Pavan, Mojca Fuart Gatnik, Simona Kovarich, Arianna Bassan

Publikováno v: Molecular informaticsReferences. 38(8-9)

Read-across is a non-testing data gap filling technique which provides information for toxicological assessments by inferring from known toxicity data of compound(s) with a "similar" property or chemical profile. The increased usage of read-across wa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3e9d403f5f16018094a5db0e4b22d80c
https://pubmed.ncbi.nlm.nih.gov/30977298

Third report on the update and maintenance of EFSA's Chemical Hazards Database

Autor: Elena Fioravanzo, Rossella Baldin, Simona Kovarich, Lidia Ceriani, Arianna Bassan, Manuela Pavan

Publikováno v: EFSA Supporting Publications. 15

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::133eecf18cf040929b78ac6f1b351950
https://doi.org/10.2903/sp.efsa.2018.en-1265