top of page
  • shelleyamaves

BioPhia Now Offers Complete Package for Toxicological Risk Assessments

BioPhia Consulting is pleased to announce the licensing of Lhasa Limited’s Derek Nexus and Sarah Nexus software offering BioPhia clients a one-stop shop for the performance of toxicological risk assessments supporting both device and drug development.

For chemicals (e.g., drug-related impurities, and extractables and leachables from materials or container closure systems) lacking experimental mutagenicity data, Derek Nexus and Sarah Nexus facilitate the identification of potentially mutagenic chemicals by fulfilling both the expert rule-based and statistical-based predictions required in ICH M7 and ISO/TS 21726 guidelines for drugs and devices, respectively.

Assessing potentially mutagenic chemicals quickly and easily and submitting those results to regulators can reduce the need for time consuming and expensive in vitro and in vivo tests for evaluating genotoxicity. Derek Nexus and Sarah Nexus predictions are accepted by regulators including the US FDA.

10 views0 comments


bottom of page