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Transportation of Bone Marrow for In Vitro Processing and Transplantation
Published in Adrian P. Gee, BONE MARROW PROCESSING and PURGING, 2020
William E. Janssen, Carlos Lee
As with fresh marrow shipping, labels must be affixed to the outside of the liquid nitrogen shipping container to inform the handler of its contents. The label shown in Figure 1 is also appropriate for this type of a shipment. However, because of the presence of the liquid nitrogen, additional labeling must be affixed to the container. An example of such a label is shown in Figure 2. The wording “Nitrogen, Refrigerated Liquid” may be in any dark color. The diamond shape must be green, and the lettering and the symbol in the diamond shape must be white. The diamond must be 4 in. on a side.6 The diamond-shaped labels are available from laboratory supply or laboratory safety companies. They are also available from vendors of compressed gases and liquid nitrogen.
Clinical Pharmacology
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
William B. Abrams, Keith H. Jones
Although estimation of efficacy has been emphasized thus far, Phase IIA studies also extend the safety and tolerability information gained in Phase I. In addition to clinical observations, laboratory safety data are collected at regular intervals before, during and after drug administration. Testing of the drug is now made more rigorous with its administration to ill persons. Proper controls must be utilized to avoid an unwarranted issue of toxicity. A special aspect of safety is the determination of drug disposition in individuals with compromised renal and liver function. Since drugs and their metabolites are eliminated by the liver and/or kidneys, it is important to identify the potential for cumulation and toxicity in such patients. Proper precautions may then be exercised in future studies and in clinical use.
Safety in the Laboratory
Published in Niel T. Constantine, Johnny D. Callahan, Douglas M. Watts, Retroviral Testing, 2020
Niel T. Constantine, Johnny D. Callahan, Douglas M. Watts
Recently, the U.S. Occupational Safety and Health Administration (OSHA) has become involved in the issue of laboratory safety by mandating that all laboratory employers must: Educate and train all health care workers in the practice of universal precautions to prevent blood-borne diseaseProvide the equipment necessary for such protection (i.e., gloves)Monitor compliance with mandated biosafety practices
A systematic analysis of and recommendations for public health events involving brucellosis from 2006 to 2019 in China
Published in Annals of Medicine, 2022
Zhiguo Liu, Miao Wang, Yaxin Tian, Zhongqiu Li, Liping Gao, Zhenjun Li
A total of 11 laboratory-acquired infection events were reported during the 2006–2016 period in China (Table 1). Two events were observed in Northern China (Beijing and Ningxia province), and the remaining nine events were found in Southern China (Zhejiang, Jiangsu, Jiangxi, and Anhui provinces). Nine of the patients were microbiological technicians and two were cleaners of a microbiology laboratory. The age range of the nine patients was 28–65 years old, and the mean age was 45 years old; two patients were men, seven were women and the remaining two were unknown. Seven patients were infected during the identification or handling of suspect Brucella strains, two by handling blood culture samples from patients with brucellosis, and the remaining individuals were infected while cleaning up the microbiology laboratory waste. All accidental infections occurred because of substandard laboratory safety conditions, manipulations outside biosafety cabinets (BSCs), or the use of inadequate personal protective equipment. All nine cases presented fever; sweating was observed in six cases, fatigue in five cases, and headache in two cases. Only one patient was suspected of brucellosis, seven cases were diagnosed with a fever of unknown origin, and one patient was diagnosed with inflammation of the psoas major muscle, reminding two cases were unknown. The ten patients were first diagnosed with brucellosis by bacteriology test, and a serology test (SAT titre ≥ 1:100) was used only in one case.
Normal lark, deviant owl: The relationship between chronotype and compliance with COVID-19 mitigation measures
Published in Chronobiology International, 2022
All experimental sessions were held at an office building located at the heart of the city center in Sichuan. On arrival at the building lobby, participants were met by an experimenter who were unaware of the hypotheses of the study. The experimenter explained several steps involved in the research process. Next, participants were informed that the laboratory room was located at this building, but on the fifth floor. They needed to get on an elevator bound for the floor. Participants were told that a hand sanitizer dispenser was mounted on the wall of entrance door of the laboratory room. Participants were requested to comply with general laboratory safety rules and to use gel sanitizers to stop the spread of germs and illness during the COVID-19 pandemic before entering the test room. A trained research assistant at a staged reception desk recorded whether participants practised hand hygiene without attracting their attention.
A randomized pharmacokinetic-pharmacodynamic evaluation of the potential biosimilar interferon beta-1a product, CinnoVex®
Published in Expert Opinion on Biological Therapy, 2022
Mika Scheinin, Zsófia Lovró, Inger-Helen Maadik, Jaana Suopanki-Lalowski, Seyed Hossein Seyedagha, Morteza Azhdarzadeh
The safety endpoints of the study included adverse events (AEs), clinical and laboratory safety parameters, vital signs, and immunogenicity. For this purpose, common anticipated AEs associated with IFN treatment (fever, chills, and myalgia) were systematically assessed prior to and at the following time points after dosing: 6, 12, 14, 16, 18, 24, 48, 72, 96, 120 and 168 hours. Occurrence of any AEs was recorded throughout the trial. AEs and ADRs reported after administration of study treatments were classified by System Organ Classes (SOC) and Preferred Terms (PT) using the MedDRA 19.1 dictionary (MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)).