Software for prediction of degradation products and API-excipient reactions (RDC53/2015, ICH Q3A/B e ANVISA's Guidance 04/2015)

Contents

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• Module A Example
• Module B Example
• Module C Example

General Approach - please see the Brochure

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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)

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General Approach - please see the Brochure

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Computational tool for calculation of purge factors (PFs) and purge ratios (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)

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General Approach: please see the Hub-Nitro Brochure

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Identification of Drug Products or API considered prioritary for Nitrosamines Assessment timelines.

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General Approach - please see the Hub-Nitro Brochure

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A Web-Systematic Tool for Nitrosamines Risk Assessment by FMEA (Failure Mode and Effect Analysis)

Contents

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General Approach - please see the Hub-Nitro Brochure

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A Carcinogenic Potency Categorization Tool.

Contents

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General Approach: please see the Hub-Nitro Brochure

And also check the Nitro-Next Brochure

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