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Drug Contamination

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Development and validation of a stability-indicating reverse phase ultra performance liquid chromatographic method for the estimation of nebivolol impurities in active pharmaceutical ingredients and pharmaceutical formulation.

Se pu = Chinese journal of chromatography
A sensitive, stability-indicating gradient reverse phase ultra performance liquid chromatographic method has been developed for the quantitative estimation of nebivolol impurities in active pharmaceutical ingredient (API) and pharmaceutical formulati...

(Q)SAR assessments of potentially mutagenic impurities: a regulatory perspective on the utility of expert knowledge and data submission.

Regulatory toxicology and pharmacology : RTP
(Quantitative) structure activity relationship [(Q)SAR] modeling is the primary tool used to evaluate the mutagenic potential associated with drug impurities. General recommendations regarding the use of (Q)SAR in regulatory decision making have rece...

Environmental contamination, product contamination and workers exposure using a robotic system for antineoplastic drug preparation.

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Environmental contamination, product contamination and technicians exposure were measured following preparation of iv bags with cyclophosphamide using the robotic system CytoCare. Wipe samples were taken inside CytoCare, in the clean room environment...

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes.

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
OBJECTIVE: The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by ...