AIMC Topic: Drug Contamination
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Simulation program of a cytotoxic compounding robot for monoclonal antibodies and anti-infectious sterile drug preparation.
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Jan 16, 2019
The aim of this study was to develop a specific simulation program for the validation of a cytotoxic compounding robot, KIRO® Oncology, for the preparation of sterile monoclonal antibodies and anti-infectious drugs. The impact of excipient formulatio...
Development and validation of a sensitive method for alkyl sulfonate genotoxic impurities determination in drug substances using gas chromatography coupled to triple quadrupole mass spectrometry.
Journal of pharmaceutical and biomedical analysis
Dec 30, 2018
Alkyl sulfonate esters have been widely concerned as genotoxic impurities (GTIs). A gas chromatography triple-quadrupole mass spectrometry (GC-MS/MS) method has been developed for trace determination of 9 commonly encountered sulfonate esters in drug...
Hantzsch pre-column derivatization for simultaneous determination of alendronate sodium and its pharmacopoeial related impurity: Comparative study with synchronous fluorometry using fluorescamine.
Journal of food and drug analysis
Jun 18, 2018
High performance liquid chromatographic (HPLC) method with a pre-column derivatization based on Hantzsch condensation reaction was applied for simultaneous determination of alendronate sodium (ALN) and its main related impurity, 4-Aminobutanoic acid ...
Nanoparticle based bio-bar code technology for trace analysis of aflatoxin B1 in Chinese herbs.
Journal of food and drug analysis
Dec 6, 2017
A novel and sensitive assay for aflatoxin B1 (AFB1) detection has been developed by using bio-bar code assay (BCA). The method that relies on polyclonal antibodies encoded with DNA modified gold nanoparticle (NP) and monoclonal antibodies modified ma...
Rapid detection of six phosphodiesterase type 5 enzyme inhibitors in healthcare products using thin-layer chromatography and surface enhanced Raman spectroscopy combined with BP neural network.
Journal of separation science
May 12, 2017
A novel facile method for the detection of the phosphodiesterase type 5 enzyme inhibitors added illegally into health products was established using thin-layer chromatography and surface enhanced Raman spectroscopy combined with BP neural network. Wh...
Stability of sodium bicarbonate injection 8.4% in syringes over a six-week period in refrigerated temperature.
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Feb 20, 2017
Background Dysfunctional central venous catheter prohibits the administration of potential life-saving chemotherapy and the delivery of essential supportive care needs to patients. Sodium bicarbonate injection has been shown to impede against fibrin ...
Distinguishing between expert and statistical systems for application under ICH M7.
Regulatory toxicology and pharmacology : RTP
Jan 3, 2017
Humans
Animals
Risk Assessment
Models, Statistical
Patient Safety
Computer Simulation
Reproducibility of Results
Mutagenicity Tests
Mutagens
Data Interpretation, Statistical
Policy Making
Quantitative Structure-Activity Relationship
Molecular Structure
Drug and Narcotic Control
Drug Contamination
Expert Systems
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
Dec 30, 2014
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 ...
(Q)SAR assessments of potentially mutagenic impurities: a regulatory perspective on the utility of expert knowledge and data submission.
Regulatory toxicology and pharmacology : RTP
Dec 26, 2014
(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
Feb 23, 2014
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...
Antineoplastic Agents, Alkylating
Pharmacy Service, Hospital
Air Pollutants, Occupational
Environment, Controlled
Gloves, Protective
Cyclophosphamide
Equipment Contamination
Drug Contamination
Robotics
Equipment Design
Drug Compounding
Humans
Risk Factors
Risk Assessment
Occupational Exposure
Environmental Monitoring
Infusions, Intravenous
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