Challenges and Expert Monitoring in Liposomal Amphotericin-B BE Studies
Introduction
Liposomal Amphotericin-B is a critical antifungal medication that requires careful attention during Bioequivalence (BE) studies. These studies aim to demonstrate the similarity of a generic liposomal Amphotericin B formulation to the reference drug in terms of pharmacokinetics.
Zenovel, with its extensive experience in monitoring Amphotericin B studies, can play a crucial role in overcoming the challenges associated with these complex studies.
Challenges in Liposomal Amphotericin-B Bioequivalence Studies
Concomitant Medication:
Frequent adverse events (AEs) such as skin irritation and back pain are commonly reported by subjects receiving liposomal amphotericin-B. To mitigate the risk of allergic reactions and reduce the likelihood of AEs leading to subject dropouts, concomitant medications like Paracetamol, Hydrocortisone, and dihydrophenylamin are administered to subjects before the drug’s administration. Learn More...
