Some considerations on the study of fat emulsion/amino acids/glucose injection
Fat emulsion/amino acids/glucose triple-chamber bag is an"all-in-one"parenteral nutrition solution supplied as a ready-to use formulation,which is intended for providing daily energy,essential fatty acids,amino acids and electrolytes to patients with mild to severe catabolism who are not candidates for gastrointestinal feeding,have an inadequate response to gastrointestinal feeding,or are diagnosed with gastrointestinal dysfunction.The three chambers of these products are completely isolated prior to use,while connect with each other after applying certain force during treatment.Such design can avoid the interaction between the components during sterilization and storage,increase the stability of the product,minimize the risk of secondary contamination associated with clinical use,and improve the quality of life andprognosis of the patients.This article addressed several considerations for the pharmaceutical study on the generic drugs of triple-chamber bag of fat emulsion/amino acids/glucose based on the requirements in Chinese and international guidelines as well as our recent review experience,with the aim to provide instructions for subsequent research and development.
Triple-chamber bag of fat emulsion/amino acids/glucose injectionGeneric drugsPharmaceutical study
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