Innovative Biotech Solutions for Drug Discovery | InsilicAll

Frequently asked questions

How does Detoxie handle complex mixtures or multi-component impurities?

Detoxie allows for the individual screening of multiple components within a mixture. Each structure is evaluated independently through the dual (Q)SAR systems, providing a consolidated risk summary to identify which moiety drives the mutagenic concern.

How granular is the strain-specific prediction for the Ames Test?

Detoxie provides individual probabilities for each of the five standard strains required by OECD 471: TA98, TA100, TA1535, TA1537, and WP2 uvrA. This granularity helps identify specific mutational patterns and metabolic activation (±S9).

What happens if the Expert and Statistical systems provide conflicting results?

Conflicting predictions are explicitly flagged to trigger the expert review workflow. Toxicologists can use XAI feature maps and eMuDRA Read-Across to resolve the conflict and document a scientifically sound Weight-of-Evidence conclusion.

How does the eMuDRA system ensure high-quality analogue selection?

eMuDRA uses a multi-parametric engine considering structural fingerprints (Tanimoto), electronic properties, and functional groups. It prioritizes analogues with gold-standard experimental data to justify a "negative" or "positive" call.

How does the XAI "Waterfall" analysis support the final classification?

The XAI computes per-atom contributions through a transparent waterfall audit trail. It quantifies how each chemical moiety influences the final probability, providing a clear, interpretable rationale for regulatory reviewers.

How does Detoxie treat "Cohort of Concern" (CoC) compounds?

The system identifies structures with potential CoC classification, such as N-nitrosos or aflatoxin-like compounds. It alerts the user to these high-potency mutagens, ensuring they are handled with the specific regulatory scrutiny required.

Does the platform provide specific "Acceptable Intake" (AI) values?

Yes. For compounds identified as ICH M7 Class 1 or Class 2, Detoxie assists in the calculation of Acceptable Intake (AI) based on "Cohort of Concern" logic and published TD50 values from 1,600+ carcinogenicity results.

Can Detoxie assess impurities for cosmetics or food contact materials?

While purpose-built for ICH M7, the underlying SMI-TED and Expert System engines are trained on broad datasets. This makes the platform highly effective for SCCS (cosmetics) or food additive guidelines, provided the chemical space aligns.

What is the difference between activating and deactivating alerts?

The Expert System (235+ alerts) includes activating alerts (mutagenic concern) and deactivating alerts (features that reduce mutagenic potential). This dual-logic ensures a nuanced risk evaluation, avoiding overly conservative conclusions.

Are the reports customizable for different agencies like FDA or ANVISA?

The reports follow a "Universal Regulatory-Ready" structure. They include full documentation of OECD Principles 1-5 and QMRF, allowing toxicologists to append specific justifications required by ANVISA’s RDC 964/2025 or FDA dossiers.

Back to Detoxie

Insilicall AI Platform - Global FAQ

Do I need to install any software to use the platform?

No. The Insilicall AI Platform is a fully cloud-based SaaS solution. All tools (Detoxie, Ionization Pro, Degrad Plus) are accessed via a web browser, ensuring you always operate on the latest validated version without local IT overhead.

How are system updates and validations managed?

Updates are deployed centrally following strict GAMP 5 Change Control procedures. For Enterprise clients, we provide release notes and updated validation documentation to ensure your internal Quality Management System (QMS) remains current.

Is the platform compliant with FDA 21 CFR Part 11?

Yes. The platform includes comprehensive audit trails, electronic signatures, and immutable reporting features. Every action is timestamped and attributed to a specific user, satisfying all ALCOA+ criteria for GxP environments.

What are the minimum hardware/browser requirements?

Since all heavy computations occur on our high-performance GPU clusters, you only need a modern web browser (Chrome, Firefox, or Edge) and a stable internet connection. No specialized hardware is required on the user side.

Where is the data physically stored and hosted?

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Does the platform support single sign-on (SSO)?

Yes. For Enterprise licenses, we support integration with corporate identity providers (SAML 2.0/Azure AD). This allows your team to access all Insilicall tools using their existing corporate credentials, enhancing security and user management.

How does the platform ensure high availability and uptime?

Can we export data for external reporting or LIMS?

Absolutely. All analysis results can be exported in structured formats (CSV/JSON) or as regulatory-ready, immutable PDF reports with QR code verification, allowing for seamless integration into your internal workflows.

Does the platform undergo regular security audits?

Yes. We conduct periodic vulnerability assessments and penetration testing to ensure the platform remains resilient against emerging threats. Documentation on our security posture can be shared with Enterprise IT departments under NDA.

Is there a limit to the number of concurrent users?

What happens to our data if we terminate the subscription?

Is training provided for new platform users?

How do you handle data privacy and GDPR/LGPD compliance?

Insilicall is committed to global data privacy standards. We act as a data processor, ensuring that all personal and research data is handled according to strict privacy protocols and regional regulations like LGPD and GDPR.

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