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Advance

Comprehensive solution aligns with ICH S1B WoE Addendum for assessing carcinogenicity risk using six specialized modules.

Solution by Instem
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Overview

Advance is a comprehensive life science software that aligns with the ICH S1B Weight of Evidence (WoE) Addendum to assess carcinogenicity risk. It integrates six specialized modules, each targeting guideline-defined factors, to streamline early-stage safety evaluations. This software aims to reduce costs, save time, and minimize dependence on animal testing through effective data analysis.

The service allows researchers to produce industry-standard carcinogenicity assessments rapidly, potentially avoiding the substantial time and resource demands of traditional animal-based studies. Advance evaluates the necessity of conducting a two-year rat carcinogenicity study by analyzing comprehensive toxicological datasets, including in silico resources.

Drug discovery is both time-consuming and costly, with timelines significantly affecting expenses. By adhering to the ICH S1B WoE Addendum, Advance aids researchers in avoiding the extensive commitments of two-year carcinogenicity studies, promoting efficient and cost-effective research processes.

Key Benefits of Advance

  • Saves Time: Researchers can possibly shorten market readiness by 3-5 years, integrating seamlessly into existing workflows.
  • Reduces Reliance on Animal Testing: Supports the growing movement towards minimizing animal use, aligning with the 3Rs principles.
  • Expert-led: Developed by professionals with ICH S1B framework experience, ensuring scientific rigor and regulatory alignment.
  • Lowers Costs: Potential savings of $2-$4 million by circumventing multi-year carcinogenicity studies.
  • Scalable: The dataset expands in tandem with in-house and public data throughout the development phases.

Core Modules

The suite includes modules focusing on target biology, secondary pharmacology, histopathology, and more. These tools offer insights into risks like tumor development and systemic toxicity, ensuring thorough therapeutic and safety profile evaluations.

  • Target Biology: Assesses roles in tumor development through expression profiles and pathway analysis.
  • Secondary Pharmacology: Evaluates off-target interactions and unintended effects via in vitro assays and computational methods.
  • Histopathology: Identifies tissue-level responses, aiding in the interpretation of systemic toxicity.
  • Hormonal Perturbation: Examines microscopic changes affecting hormonal balance and potential developmental toxicity.
  • Genotoxicity: Integrates assays to evaluate the potential for DNA damage.
  • Immune Modulation: Extracts data to assess potential immune-related effects, such as immunosuppression.

Meta

Category
Assay Design & Analysis
Field(s)
Quality & Compliance
Target user(s)
Clinical / Diagnostic ProfessionalBench Scientist / Lab Technician
Tag(s)
Drug Discovery