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Les bonnes pratiques de laboratoire (BPL) représentent un système d'assurance qualité pour les laboratoires impliqués dans des essais non cliniques. ll s'agit essentiellement de laboratoires réalisant des études sur la sécurité de substances chimiques ou biologiques dans des domaines tels que la santé humaine ou animale, ou l'environnement. Les règles de BPL ont été énoncées par l'Organisation de coopération et de développement économique (OCDE). Elles ont fait l'objet d'une directive européenne transposée dans le droit national de chacun des pays membres. Les principes de BPL sont des exigences de qualité souvent très comparables aux exigences de la norme NF EN ISO 15189 pour les laboratoires de biologie médicale avec cependant des différences liées au fait que ces deux systèmes s'adressent à des laboratoires exerçant des activités fondamentalement différentes. Good Laboratory Practice (GLP) is a quality assurance system for laboratories involved in non-clinical studies. These are essentially laboratories conducting studies on the safety of chemical or biological substances in areas such as human or animal health, or environment. The GLP rules have been laid down by the Organization for Economic Cooperation and Development (OECD). They have been the subject of a European directive transposed into the national law of each of the member countries. The principles of GLP are quality requirements that are often very similar to the requirements of the NF EN ISO 15189 standard for Medical Biology laboratories, but with differences due to the fact that these two systems are intended for laboratories with fundamentally different activities. [ABSTRACT FROM AUTHOR]

In September 2012, the United States Department of Health and Human Services Food and Drug Administration's (FDA) Office of Counterterrorism and Emerging Threats and the University of Texas Medical Branch at Galveston entered into a collaborative educational partnership for the academic development of a robust training program for good laboratory practices in high-biocontainment environments. The implementation of problem-based learning techniques encouraged researchers and regulators to cross-educate each other on the challenges related to the conduct of regulated studies in biological safety level 4 (BSL-4) laboratories and identified solutions that were acceptable from scientific and regulatory perspectives. The result was the development of a face-to-face course entitled Achieving Data Quality and Integrity in Maximum Containment Laboratories and an additional online companion course covering the FDA regulation, Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58). The course offers a unique opportunity for members of the regulatory and scientific communities to solve complex issues in an interactive educational environment, especially for the advancement of medical countermeasures (MCMs) via the FDA Animal Rule (21 CFR Parts 314 and 601 (2002)). The program occurs annually and is expanding in 2019 to include a course addressing data quality and integrity in clinical trials involving the evaluation of MCMs for high-consequence pathogens. To date, 311 individuals have attended the course. Based on attendance numbers, diversity of participation (by affiliation and area of expertise), and self-reported evaluation results, course attendees indicate that the training program addresses a knowledge gap and that they will implement knowledge gained. In September 2012, the US Department of Health and Human Services FDA Office of Counterterrorism and Emerging Threats and the University of Texas Medical Branch at Galveston entered into a collaborative educational partnership for the academic development of a robust training program for good laboratory practices in high-biocontainment environments. The result was the development of a face-to-face course entitled Achieving Data Quality and Integrity in Maximum Containment Laboratories and an additional online companion course covering the FDA regulation, Good Laboratory Practice for Nonclinical Laboratory Studies. [ABSTRACT FROM AUTHOR]

We are investigating an imaging agent that detects early-stage primary colorectal cancer on the mucosal surface in real time under colonoscopic observation. The imaging agent, which is named the nanobeacon, is fluorescent nanospheres conjugated with peanut agglutinin and poly( N -vinylacetamide). Its potential use as an imaging tool for colorectal cancer has been thoroughly validated in numerous studies. Here, toxicities of the nanobeacon were assessed in rats. The nanobeacon was prepared according to the synthetic manner which is being established as the Good Manufacturing Practice-guided production. The rat study was performed in accordance with Good Laboratory Practice regulations. No nanobeacon treatment-related toxicity was observed. The no observable adverse effect levels (NOAEL) of the nanobeacon in 7-day consecutive oral administration and single intrarectal administration were estimated to be more than 1000 mg/kg/day and 50 mg/kg/day, respectively. We concluded that the nanobeacon could be developed as a safe diagnostic agent for colonoscopy applications. From the Clinical Editor Colon cancer remains a major cause of death. Early detection can result in early treatment and thus survival. In this article, the authors tested potential systemic toxicity of coumarin 6-encapsulated polystyrene nanospheres conjugated with peanut agglutinin (PNA) and poly(N-vinylacetamide) (PNVA), which had been shown to bind specifically to colonic cancer cells and thus very promising in colonoscopic detection of cancer cells. [ABSTRACT FROM AUTHOR]

Copyright of Gazi University Journal of Gazi Educational Faculty (GUJGEF) is the property of Gazi University Journal of Gazi Educational Faculty (GUJGEF) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Polypropylene (PP) is the second most highly produced plastic worldwide, and its microplastic forms are found in water and food matrices. However, the effects of PP microplastics on human health remain largely unknown. Here, we prepared 85.2 µm-sized weathered PP (w-PP) microplastics by sieving the microplastic particles after fragmentation and accelerated weathering processes. The prepared particles are irregular in shape and no chemical additives including phthalates and bisphenol A were not released in simulated body fluids. Then, the w-PP samples were gavaged to rats for acute and subacute toxicity testing in accordance to the Organization for Economic Co-operation and Development (OECD) test guidelines under good laboratory practice regulations. The highest dose for gavaging to rats was 25 mg/kg bw/day, which was the maximum feasible dose based on the dispersibility of microplastics. Both toxicity testings for w-PP microplastics showed no adverse effects and mutagenicity. Thus, the no observed adverse effect level (NOAEL) of w-PP microplastics is higher than 25 mg/kg bw/day. Furthermore, the w-PP microplastics did not show any skin or eye irritation potentials in the 3-dimensional reconstructed human skin or corneal culture model. The dose of 25 mg/kg of w-PP microplastics is roughly equal to 2.82 × 105 particles/kg, which suggests that human exposure to w-PP microplastics in a real-life situation may not have any adverse effects. [Display omitted] • The 4-week repeated oral toxicity study of w-PP showed no toxic effects. • The NOAEL of w-PP microplastics is 25 mg/kg bw/day. • w-PP showed no genotoxic potential in rat bone marrow micronucleus test. • w-PP showed no skin and eye irritation potential in 3-D reconstructed culture model. [ABSTRACT FROM AUTHOR]

Copyright of Medycyna Pracy is the property of Instytut Medycyny Pracy im. Jerzego Nofera and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)