Diluent - Drug & Drug - Drug compatibility testing
Intravenous (IV) administration of many sterile drug products requires admixture preparation using a diluent, brief storage in an IV container, and dosing through an infusion device. To ensure patient safety and drug efficacy, regulatory agencies require that the sterile drug product is compatible with the diluents and the infusion devices. Therefore, admixture compatibility and stability studies are key components of the pharmaceutical development process. On the surface these studies may seem straightforward, but in practice they require detailed planning, meticulous execution, and appropriate data analysis.
KMS Pharma undertakes Drug- Diluent and Drug-Drug with different packaging types compatibility study, conducted in accordance with various guidelines such as FDA , EMC guideline etc.