A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently. Methodology and Main Findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings. Conclusion: A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of. Summary Points: 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.

Growth, characterization and optical quality of CaF2 single crystals grown by the temperature gradient technique

The CaF2 single crystals with diameters up to 200 mm were successfully grown by modified temperature gradient technique (TGT), which are suitable for application as optical elements in the ultraviolet range. The optimizations of various growth parameters were systematically studied. Properties of as-grown CaF2 crystals were characterized by the nature of inclusions, dislocations, crystallinity, and impurities contents. The results showed that the dislocations and multinucleation were mostly constrained in the conical part of the crystals with the cylindrical parts having the best crystalline quality and lowest impurity contents. The high optical quality of TGT-grown CaF2 single crystals was also confirmed to have excellent optical transmission in 190-2500 nm and refractive index homogeneity. (c) 2005 Elsevier Ltd. All rights reserved.

Growth and characterization of high-quality LiAlO2 single crystal

g-LiAlO2 single crystal is a promising substrate for GaN heteroepitaxy. In this paper, we present the growth of large-sized LiAlO2 crystal by modified Czochralski method. The crystal quality was characterized by high-resolution X-ray diffraction and chemical etching. The results show that the as-grown crystal has perfect quality with the full width at half maximum (FWHM) of 17.7-22.6 arcsec and etch pits density of (0.3-2.2) x 10(4) cm(-2) throughout the crystal boule. The bottom of the crystal boule shows the best quality. The optical transmission spectra from UV to IR exhibits that the crystal is transparent from 0.2 to 5.5 mu m and becomes completely absorbing around 6.7 mu m wavelength. The optical absorption edge in near UV region is about 191 nm.

Management of broodstock and quality control of fish seed in Hungary

Common carp (Cyprinus carpio) breeding has a long tradition in Hungary. However, recent economic changes in Eastern Europe and new developments in aquaculture necessitated the need for ensuring quality of the brood stock used in hatcheries and the legal and institutional frameworks needed to implement the program. In addition to good research and development programs and gene banking, it became essential to establish an appropriate legal framework, organize, coordinate and control breeding activities, and provide financial support. It was a major breakthrough for carp breeding when C.carpio was recognized as one of the cultivated animals in the Animal Breeding Act in 1993. The Carp Breeding Section of the Hungarian Fish Producers Association plays an important role in carp breeding programs. Thirteen breeding farms of the Carp Breeding Section have 24 certified C.carpio varieties. In Hungary, about 80 % of the seed used as stocking for commercial production are from high quality certified breeders.