How Do You Derive an Acceptable Intake Limit for a Novel NDSRI with No Existing Toxicology Data?
Introduction: Deriving an NDSRI Acceptable Intake Limit for a novel nitrosamine drug substance-related impurity with no existing toxicology data is […]
What Is a ‘Reasonably Expected’ Nitrosamine Under FDA’s Guidance and How Does It Affect Your Risk Assessment?
Introduction: A “reasonably expected” nitrosamine is one that your chemistry, process, materials or storage make plausible, and that judgment decides
Regulatory Starting Materials for Synthetic Peptides: How to Justify Them Under ICH Q11
Introduction Justifying Regulatory Starting Materials for Synthetic Peptides under the International Council for Harmonisation (ICH) Q11 guideline requires a robust
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Amino Acid Derivatives and Building Blocks: How Raw Material Quality Shapes Impurities in GMP Peptides
Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in
Neutralizing Antibody (NAb) Assays for Biosimilars: Assay Format, Cut Points and Comparative Interpretation
Introduction Neutralizing Antibody (NAb) Assays for Biosimilars evaluate the functional ability of anti-drug antibodies (ADAs) to inhibit the mechanism of
Case Study: PCL Subcutaneous Implant Development for 12-Month Hormonal Drug Delivery
Introduction: PCL Subcutaneous Implant Development is an emerging approach for designing long-acting hormonal drug delivery systems that may release an
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From Research Reagent to Approved Drug: How Therapeutic Peptides Evolved Over 50 Years
Introduction The evolution of therapeutic peptides from research reagents to approved drugs over the past 50 years represents a major
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Pharmacodynamic Biomarkers in Biosimilar Development: How to Select, Validate and Use PD Markers
Introduction Pharmacodynamic Biomarkers in Biosimilar Development provide precise, quantitative measurements of a biological drug’s pharmacological activity and target engagement, enabling
Designing a Comparative PK Similarity Study for Biosimilars: Population, Equivalence Margins and Sample Size
Introduction Designing a Comparative PK Similarity Study for Biosimilars requires the strategic integration of sensitive population selection, rigorous bioequivalence metrics,
EMA Reflection Paper on a Tailored Clinical Approach in Biosimilar Development: Key Takeaways for Developers
Introduction The adoption of the EMA Reflection Paper on a Tailored Clinical Approach introduces a modern regulatory strategy designed to