Method Development. The official laboratory shall, in agreement with the Authority and subject to available resources help in the development of new analytical capabilities for emerging risks as identified by the Authority, European Commission, the official laboratories, relevant National Reference Laboratories or other relevant bodies when required by Union rules for food safety parameters, to support official controls and/or other official control activities.
Method Development. The parties to the collective agreement agree that the part of the work studies aiming to determine the most practical production method and comprising examinations of the workplace, working conditions, tools, ancillary equipment, machines, material, means of transport etc. as well as the actual working process must normally take place before the actual fixing of piece rates. In addition, it is assumed that both the shop xxxxxxx and the work study shop xxxxxxx have access to the material used by the enterprise for method development. The health and safety group must take part in this planning and organisation of the work in order to ensure that the work may be performed observing all health and safety requirements, cf. the Danish Working Environment Act, which the safety group must certify. The health and safety group may propose changes and object with certification, but amendments and objections do not, in principle, have a suspensory effect on the completion, release and testing of the agreement.
Method Development. 11 2.1.1 The Qualitative Approach 11 2.1.2 Research Model 12 2.2 Literature 13 2.2.1 Sources of information 13 2.2.2 Literature search 14 2.3 Collection of Data 15 2.3.2 Documents 15 2.3.3 Interviews 15 2.3.4 Data sampling for interviews 16 2.4 Data Analysis 17 2.4.1 Thematic Analysis 17 2.4.2 Analysing interviews 18 2.5 Ethical issues 19 2.6 Reliability and Validity 20
Method Development. All partners developed with different focus numerical and analytical methods to solve their sizing problems for the concepts. On global aircraft level TsAGI implemented successfully a multilevel optimization cycle for the sizing of anisogrid fuselage barrel sections. On component level DLR has implemented a parametric analysis process for the anisogrid barrel section to provide needed Designs of Experiments for a multi parameter optimization algorithm set up by the University of Leeds. A new semi‐analytical method has been developed by XXXX‐IW for calculation of buckling value of grid‐ stiffened skin shells on element level. As result, the partners were able to get a high understanding of the structural behaviour of lattice structures, invented new design methods for these structures and performed successfully the sizing of all fuselage barrel design concepts, shown in chapter 5.
7.1 Multi‐Level Sizing Procedure for Airframe Barrel Section This algorithm is based on a multilevel approach to generate the universal parametrical finite element models which includes four FE models (levels) of different discreteness based on the specialized data base for the investigation of non‐conventional structure concepts. The algorithm consists of four main parts, each of which is responsible for its modelling level [12]: Level 1: geometrical model (specifying the geometrical parameters and external loading analysis), Level 2: constructive model (determination of inertia loads), Level 3: manufacture model (panels parameters input and solving the buckling tasks), Level 4: strength model (stress‐strain state analysis).
Method Development. Analytical methods for IPC, DS and Drug Product (DP) will be developed and qualified prior to initiation of Phase I clinical trials. Methods will be developed in-house or contracted to a CMO depending on the complexity or nature of the assay. This will initially be performed on early process material once available. Qualification of assays will be performed upon large-scale process derived material. Assays will be transferred to the QC laboratory of the CMO or nominated sub-contractor, as appropriate, where QC release testing of cGMP lots will be undertaken. Schedule 1 Appendix 2 5
Method Development. Phthalate metabolites are typically glucuronide- or sulfate-bound in biological media such as blood or urine. Previous studies have demonstrated the efficacy of β- glucuronidase/sulfatase deconjugation by spiking all samples with 4-methylumbelliferone and observing the levels released from this conjugated standard (Kato et al., 2003) without taking into account the different kinetics of the reaction between the surrogate standard and phthalates. Thus, current phthalate methods do not quantitatively liberate the bound metabolites prior to analysis resulting in concentrations that are biased low. In order to optimize the yield of phthalate metabolite during the deconjugation step of the method, we evaluated the incubation time and enzyme amount needed for maximum yield. Response rate (RR) and concentration (ng/mL) were used to evaluate the effectiveness of each experimental condition. Xxxxx was used, as the matrix in this experimental approach as it is more readily available than FF and the methodology has been cross-validated for both matrices. Experimental parameters altered were enzyme volumes for 2-hour incubations (250, 500 and 1000µL) and a 4-hour incubation (500µL). For all detected phthalate metabolites, the 4:1 ratio of β-glucuronidase to unknown sample with a 2-hour incubation period was determined to produce the greatest yield among 250µL urine samples (Table 1), and for MiBP and MBP metabolites this increased the calculated concentration by 42% and 23% respectively. No significant additional yield was observed when incubation was increased from 2 to 4 hours; these results were in agreement with previously conducted research demonstrating that the time of incubation (~90 min) was adequate of the amount of glucuronide used (Xxxxx et al. 2008).
Method Development. The Official Agency agrees that, subject to available resources, to help in the development of new analytical capabilities for emerging risks as identified by the Authority, European Commission, the official laboratories, relevant National Reference Laboratories or other relevant bodies when required by Union rules for food safety parameters, to support official controls and/or other official control activities.
Method Development. The Official laboratories of the Food Safety Laboratory Service shall, in agreement with the Authority and subject to available resources, contribute to the development of new analytical capabilities for emerging risks as identified by the Authority, European Commission, the official laboratories, relevant National Reference Laboratories or other relevant bodies when required by Union rules for food safety parameters, to support official controls and/or other official control activities. The Authority shall receive regular updates on parameters that are undergoing method development or proposals for method development through a standing agenda item for the planned FSAI/PAL and FSAI/OFML Liaison meetings.
Method Development. The method developed is based on the four research questions outlined in chapter 1.2.2, and consists of a qualitative approach using semi-structured interviews and documents analysis.
Method Development. The parties agree that the part of the work studies aiming to determine the most practi- cal production method and comprising examinations of the workplace, working condi- tions, tools, ancillary equipment, machines, material, means of transport etc. as well as the actual working process must normally take place before the actual fixing of piece rates. In addition, it is assumed that both the shop xxxxxxx and the work study shop xxxxxxx have access to the material used by the enterprise for method development. The safety group must take part in this planning and organisation of the work in order to ensure that the work may be performed observing all safety and health require- ments, cf. the Danish Working Environment Act, which the safety group must certify.
