Do All Drug Products Need a Nitrosamine Risk Assessment? FDA’s Risk-Based Approach Explained
Assessing the chemical safety of human drug products requires a thorough understanding of potential mutagenic and carcinogenic impurities that fall […]
Case Study: Accelerated Phase I Bioanalytical Support for a CNS Small Molecule Under FDA Fast Track
Navigating Clinical Translation of CNS Small Molecules Under FDA Fast Track The clinical translation of central nervous system (CNS)-active small
Peptide Reference Standard Qualification: Analytical Requirements for Regulatory and Assay Use
Introduction: In peptide drug development, the quality of your analytical data is only as good as the reference standard anchoring
Common Root Causes of Failed Extractables and Leachables (E&L) Studies and How to Avoid Them
Identifying and addressing the root causes of failed Extractables and Leachables (E&L) studies has become a critical regulatory requirement for
Understanding Burst Release in PLGA Formulations — Causes, Consequences, and Mitigation
Introduction Burst release in PLGA formulations is one of the most clinically consequential — and analytically challenging — phenomena in
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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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