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Evolution of the implementation of a quality management system in the Belgian laboratories for anatomic pathology
framework of this licensing the laboratories are obliged to elaborate a quality management system within five years. However, the requirements concerning topics like access/safety and hygiene, maintenance ...
General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.
one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically ...
Pharmacokinetics of a loading dose of amikacin in septic patients undergoing continuous renal replacement therapy87
the time to C(min) <5mg/L. In septic shock patients treated with CRRT, a first dose of > /= 25 mg/kg amikacin is therefore required to reach therapeutic peak concentrations. However, as drug ...
Regulatory requirements for the labelling of IVDs in Europe4223
guidance guidance document IVD language medical ON Regulatory Requirements Abstract: Anne Van Nerom Service: Quality of laboratories Kwaliteit van laboratoria Qualité des laboratoires Manuscript versions: ...
Effect of lyophilized lactobacilli and 0.03 mg estriol (Gynoflor(R)) on vaginitis and vaginosis with disrupted vaginal microflora: a multicenter, randomized, single-blind, active-controlled pilot study69
equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month. Further studies are required to evaluate the long-term efficacy of lactobacilli when ...
Revisiting the loading dose of amikacin for patients with severe sepsis and septic shock90
patients with severe sepsis and septic shock have an increased Vd, a first dose of >or= 25 mg/kg (total body weight) of amikacin is required to reach therapeutic peak concentrations. However, even with ...
Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.
monograph for varicella vaccine (live) (0648) requires a vial of an appropriate reference material to be titred in triplicate to validate each assay and the virus concentration of the reference preparation is ...
Development of a genetic traceability test in pig based on single nucleotide polymorphism detection33
Medicine work Abstract: In order to assure traceability along the meat transformation process, a powerful system is required. The administrative traceability shows limits that the use of genetic markers ...
Tracability in meat processing: The genetic markers212
tracability system is required. The administrative tracability shows limits that the use of genetic markers could overcome. The individual genome contains sequence differences, basis of the genetic polymorphism ...
Effect of accreditation schemes on the setting of quality specifications by laboratories
public public health Public-health Quality Quality Control Requirements result results Service Services specific standards System Term Test Abstract: In the future, there will be a universal standard for ...