What Happens When a Nitrosamine Exceeds the Acceptable Intake Limit? Steps a Sponsor Must Take
Introduction: When a nitrosamine exceeds the acceptable intake limit in a drug product or active pharmaceutical ingredient (API), it triggers […]
Extractables and Leachables (E&L) Testing for Container Closure Integrity Programs
Introduction: Patient safety begins long before a drug product reaches the clinic — it begins with the container that holds
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Carmustine PLGA Wafer Characterization: Analytical Challenges in Solid Implant Drug Delivery Systems
Introduction: Carmustine PLGA characterization sits at the intersection of polymer science, oncology pharmacology, and regulatory compliance — making it one
Aripiprazole Lauroxil Depot Characterization: Dual Complexity of Prodrug Conversion and PLGA Degradation
Introduction: Aripiprazole lauroxil (Aristada®) is a PLGA-based long-acting injectable antipsychotic that differs fundamentally from other LAI microsphere products. As discussed
Comparative Testing Between Generic and RLD: Best Practices for ANDA
Introduction to Comparative Testing Between Generic and RLD Comparative Testing Between Generic and RLD serves as a fundamental regulatory and
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PLGA Implant Characterization Case Study: Goserelin Implant Polymer Degradation and Release Correlation
Introduction: Goserelin PLGA implant characterization is one of the most technically demanding challenges in long-acting parenteral development — and also
Biosimilar Characterization Services Using Mass Spectrometry
The Strategic Role of Biosimilar Characterization Services in Biopharmaceutical Approvals Biosimilar Characterization Services play a critical role in establishing analytical
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How Pharmaceutical Companies Prepare for FDA Questions on Extractables and Leachables (E&L) Data
Understanding the Regulatory Landscape of FDA Questions on E&L Studies The Food and Drug Administration (FDA) carefully evaluates extractables and
Insulin Analog Characterization for Generic ANDA: Peptide Mapping, Sequencing, and Sameness Strategy
Introduction: Insulin analog characterization for generic ANDA is one of the most scientifically demanding challenges in the follow-on biologics space.
Higher-Order Structure (HOS) Characterization of Therapeutic Peptides: Methods and Regulatory Expectations
Introduction: Higher-order structure characterization of therapeutic peptides is no longer optional science — it is a regulatory and scientific imperative.