Rishab Kumar

Background

About Rishab Kumar

Comprehensive knowledge and experience in the drafting and calculation of Health-Based Exposure Limits (HBELs), including Permitted Daily Exposure (PDE), Acceptable Daily Exposure (ADE), and Occupational Exposure Limits (OEL). My work aligns with key guidelines such as ICH Q3D, APIC, EMA, and PIC/S, ensuring regulatory compliance and safety standards are met. I have a proven track record in overseeing detailed risk assessments to identify potential hazards from synthetic chemicals, metabolites, plant-derived substances, elemental impurities, and endogenous chemicals/products. This includes evaluating potential harmful effects and ensuring appropriate mitigation strategies are implemented. Additionally, I specialize in the assessment and control of DNA-reactive (mutagenic) impurities in pharmaceuticals. My work follows the ICH M7 guideline, focusing on the identification, categorization, qualification, and control of mutagenic impurities to minimize potential carcinogenic risks. I am proficient in utilizing in-silico software tools like CASE Ultra and DEREK Nexus, applying expert rule-based and statistical methodologies. This experience enables me to generate comprehensive mutagenicity assessment reports covering endpoints such as mutagenicity/genotoxicity, skin sensitization, reprotoxicity, organ toxicity and carcinogenicity. Furthermore, I have experience in the preparation of risk assessment reports for nitrosamine impurities, ensuring pharmaceutical products adhere to the highest safety standards.