5PSQ-112 Risk assessment of elemental impurties for manufacturing the drug substance (ICH Q3D)

Abstract

QALY (one case) were also apparent. In contrast, the input parameters were quite different. Every analysis demonstrated cost-reduction and patient safety enhancement but methodological differences were present in terms of perspective, discounting, duration, inflation, sensitivity, inputs and definitions (e.g. definition of ADE). Conclusion The different outcome data types used in studies counter the intention to prove the cost-effectiveness of CPOE systems. It is clear that no generally accepted definition is present over which system can be called CPOE. On the other hand, it will only be possible to compare different CPOEs if common agreement is developed in terms of outcomes observed by studies. Clinical pharmacists can play an important role in the unification of the upcoming studies and collection of data. REFERENCES AND/OR ACKNOWLEDGEMENTSThanks to the help of my co-workers and the guidance of our leaders.No conflict of interest.

ICP-OES elemental impurities study on different pharmaceutical dosage forms of Ibuprofen using microwave-assisted digestion procedure

“…Driven by the requirements established by the Guideline for Elemental Impurities-Q3D of the International Conference on Harmonization (ICH), as well as respecting Pharmacopeias, the pharmaceutical industry confronts the vast challenge of developing fast and precise procedures for sample preparation, as well as developing methods for accurate determination of EI using modern analytical methods. The ICH Q3D guideline evaluates the toxicity data of EI, establishing Permitted Daily Exposure (PDE) for each element of toxicological concern and provides a platform for application of a risk-based approach to control EI in drug products [1][2][3][4][5].…”