Pharma-Hub
Software for prediction of degradation products and API-excipient reactions (RDC53/2015, ICH Q3A/B e ANVISA's Guidance 04/2015).
Software with rule and statistical-based models for mutagenicity assessment of drug impurities based on the ICH M7 criteria (Including RDC53, M7 and ANVISA's RDC 359/22 - Section 3.2.S.3.2 of the CTD).
Computational tool for calculation of purge factors (PFs) and purge rations (PRs) for potentially mutagenic impurities (PMI) and mutagenic impurities (MIs) and automatic decision about control options from the ICH M7 criteria (Option 4 of ICH M7).
Identification of Drug Products or API considered prioritary for Nitrosamines Assessment timelines.
A Web-Systematic Tool for Nitrosamines Risk Assessment by FMEA (Failure Mode and Effect Analysis).
A Carcinogenic Potency Categorization Tool.
Other tools (freely available)
Tox Researcher – uma ferramenta de busca que combina palavras-chave com descritores moleculares dados pelo usuário para encontrar links relacionados – como páginas da web e documentos.
RDC53 Mapeamento – uma aplicação de colagem para impurezas e produtos de degradação. Com esta ferramenta é possível avaliar quais produtos de degradação ou impurezas devem ser notificados, identificados e/ou qualificados.
IS-Tox
Genotox-iS™:
Software for the prediction of mutagenicity by alerts, statistical, and machine learning-based models.
IrriTest™:
Software for the prediction of skin corrosion and irritation by alerts, statistical, and machine learning-based models with accumulative evidence from experimental data.
AOP-Sens™:
Software for the prediction of skin sensitization by alerts, statistical, and machine learning-based models, in a logical adverse outcome pathway (AOP) framework that balances transparency, mechanistic interpretability, and predictivity.
iS-Ocular™:
Software for the prediction of ocular corrosion and irritation by alerts, statistical, and machine learning-based models.
Acute-Tox™:
Software for the prediction of acute toxicity by statistical and machine learning-based models.
Pred-Oral™:
Software for the prediction of oral bioavailability and permeability Caco-2 by statistical and machine learning-based models.
Pred-CYP2D (metabolism)™:
Software for the prediction of metabolites by statistical and machine learning-based models.
iS-Liver™:
Software for the prediction of in vitro and in vivo hepatotoxicity by statistical and machine learning-based models in a logical adverse outcome pathway (AOP) framework.
DevTox-iS™:
Software for the prediction of developmental toxicity by statistical and machine learning-based models.
