Introduction: A “reasonably expected” nitrosamine is one that your chemistry, process, materials or storage make plausible, and that judgment decides […]
Introduction Justifying Regulatory Starting Materials for Synthetic Peptides under the International Council for Harmonisation (ICH) Q11 guideline requires a robust
Regulatory Starting Materials for Synthetic Peptides: How to Justify Them Under ICH Q11 Read More »
Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in
Introduction Neutralizing Antibody (NAb) Assays for Biosimilars evaluate the functional ability of anti-drug antibodies (ADAs) to inhibit the mechanism of
Introduction: PCL Subcutaneous Implant Development is an emerging approach for designing long-acting hormonal drug delivery systems that may release an
Case Study: PCL Subcutaneous Implant Development for 12-Month Hormonal Drug Delivery Read More »
Introduction The evolution of therapeutic peptides from research reagents to approved drugs over the past 50 years represents a major
From Research Reagent to Approved Drug: How Therapeutic Peptides Evolved Over 50 Years Read More »
Introduction Pharmacodynamic Biomarkers in Biosimilar Development provide precise, quantitative measurements of a biological drug’s pharmacological activity and target engagement, enabling
Introduction Designing a Comparative PK Similarity Study for Biosimilars requires the strategic integration of sensitive population selection, rigorous bioequivalence metrics,
Introduction The adoption of the EMA Reflection Paper on a Tailored Clinical Approach introduces a modern regulatory strategy designed to
Introduction Health Canada’s 2026 Biosimilar Guidance establishes a modernized regulatory framework that formally removes the routine requirement for comparative Phase
