FDA

Abstract Extended-release (ER) oral formulations provide therapeutic and practical benefits for pediatric patients by minimizing fluctuations in systemic exposure, reducing...

Abstract This study aimed to develop strategies to prevent accelerated drug release (alcohol-induced dose dumping) from modified-release matrix tablets in...

Abstract Sepsis is a life-threatening organ dysfunction resulting from a dysregulated host response to infection and remains a major public...

Abstract This work presents a method optimization strategy for determining nitrite ions in pharmaceutical excipients. After derivatization, nitrite ions were...

Abstract Machine learning (ML) is expected to accelerate the developments of three-dimensional (3D) printed medicines. Despite ML’s potential, the need...

Abstract Halogens, particularly fluorine, chlorine, and bromine, play a pivotal role in modern drug discovery and development. Their incorporation into...

Abstract The Knowledge-Aided Assessment and Structured Application (KASA) is an initiative led by the FDA’s Center for Drug Evaluation and...

Abstract Orally disintegrating tablets (ODTs) are a solid oral dosage form designed to rapidly disintegrate in the mouth without the...

Abstract Parenteral therapies are vital in critical care, oncology, and nutrition, offering rapid onset, precise dosing, and high bioavailability. However,...

Abstract Excipients, historically regarded as inert, are now being recognised for their ability to actively modulate biological targets, including intestinal...