Summary (Key Takeaways) Introduction: Defining Nitrosamine Specification Setting in the Pharmaceutical Context Nitrosamine Specification Setting refers to the systematic process […]
Establishing Specifications for Nitrosamines in Drug Substances and Drug Products Read More »
Introduction Small molecule bioanalysis remains one of the most critical disciplines in pharmaceutical research and development, serving as the foundation
Small Molecule vs. Large Molecule Bioanalysis: Key Differences Read More »
Introduction: The Nexus Between Nitrosamine AI Limit and CPCA Category The connection between the Nitrosamine AI limit and CPCA category
The Role of Acceptable Intake (AI) Limit Derivation and CPCA Category Assignment Read More »
Introduction Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines are a critical toxicological tool used when patient exposure to nitrosamine impurities occurs
Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines: When and How to Apply Read More »
Introduction: Why Bioanalysis in Drug Development Is Critical Today Bioanalysis in drug development plays a foundational role in translating a
The Role of Bioanalysis in Modern Drug Development Read More »
🔹 Executive Summary Introduction: Understanding the Nitrosamine AI Limits Comparison When conducting a Nitrosamine AI limits Comparison across major regulatory
Global Regulatory Divergence: FDA vs. EMA vs. Health Canada on AI Limits Read More »
Introduction: Understanding the Impact of ICH M7(R2) Updates on Nitrosamine Risk Assessment The Impact of ICH M7(R2) Updates on Nitrosamine
The Impact of ICH M7(R2) Updates on Nitrosamine Risk Assessment and Control Read More »
Introduction: Bioanalytical services are specialized laboratory services that measure drugs, metabolites, and biomarkers in biological samples to support pharmaceutical and
What are Bioanalytical Services? A Comprehensive 2026 Guide Read More »
🔍 Summary: Key Insights Introduction: Why the Nitrosamine CPCA Approach for NDSRIs Matters The Nitrosamine CPCA approach for NDSRIs (Carcinogenic
Implementing the Carcinogenic Potency Categorization Approach (CPCA) for NDSRIs Read More »
🧪 Introduction: Direct Injection vs. Headspace Techniques for Nitrosamine Volatiles in APIs When discussing Direct Injection vs. Headspace Techniques for
Direct Injection vs. Headspace Techniques for Nitrosamine Volatiles in APIs Read More »
