This report describes the intra-oral distribution of caries and frequency of reported toothache using data from 9690 South Australian children aged 5-15 years. School dental therapists and dentists recorded dmfs and DMFS data and a questionnaire to parents sought information about toothache and its impact. There were higher levels of caries experience in deciduous teeth (mean 6-year-old dmfs = 2.61) compared with permanent teeth (mean 12-year-old DMFS = 1.15). In the deciduous dentition: between 11.4 per cent (9-year-olds) and 37.7 per cent (5-year-olds) of total dmfs was present as untreated decay; between 39.1 per cent (7-year-olds) and 42.8 per cent (10-year-olds) occurred on interproximal surfaces; and between 2.0 per cent (10-year-olds) and 27.8 per cent (5-year-olds) occurred in anterior teeth. In the permanent dentition, the majority of permanent caries experience occurred as fillings in pits and fissures of first molars and involved a single surface. Between 11.8 per cent (5-year-olds) and 31.8 per cent (12-year-olds) of children had a reported history of toothache, although the figure exceeded 50 per cent among children with all three forms of pit/fissure, interproximal and smooth-surface caries experience. The observed pattern of caries provides the basis for continued use of fissure sealants as a preventive measure among school children.
Lucerne plots were irrigated with waters of electrical conductivity (EC) = 0.1, 0.8, 2.5, 4.5 and 7.5 dS/m for the summers of 1991–92 to 1994–95. Within those 4 years, soils were sodified at irrigation treatment salinities greater than 0.8 dS/m. Subsequent leaching of salts with channel water (EC = 0.1 dS/m) and rain water (1995–97) reduced surface soil sodicity but not subsoil sodicity. This resulted in increased dispersed clay in the subsoil. Clay dispersion was best explained by exchangeable sodium percentage (ESP) and Mg in topsoils, and by ESP and salinity (TCC or Cl) in subsoils. Ponding of water, following a 46 mm spring rainfall event, increased with ESP of topsoils. Short-term millet yields over the 1996–97 summer were not affected by soil sodicity despite channel water irrigation. However, cumulative pasture yields over 1997 decreased by 25% between high and low levels of residual soil sodicity.
This paper summarises the outcomes of the International Sodicity Conference, ‘Sodicity Issues in Agricultural Industries — Current Research and Future Directions’, held at Tatura, Victoria, 28 February–1 March 2000. In this paper we present (i) sodicity issues generic across agricultural industries, (ii) results of the interactive workshop, and (iii) knowledge gaps identified specifically for individual agricultural industries by experienced researchers. A priority ranking was given to the key issues raised within industry groups at the interactive workshop. Knowledge gaps for major agricultural industries were specifically listed to enable researchers and funding bodies alike to set future directions in sodicity research.
BackgroundThe COVID-19 public health emergency limited the U.S. Food and Drug Administration’s ability to conduct on-site good clinical practice (GCP) inspections. Alternative tools therefore have been used by FDA during the pandemic to evaluate the reliability and integrity of clinical trial data for marketing applications. However, no systematic assessment of the pandemic impact on in-person GCP inspections has been conducted. In addition, the alternative tools and their contribution to GCP oversight have not been reported. MethodsThis retrospective study reviewed databases internal to FDA and identified and characterized alternative tools used in lieu of on-site GCP inspections in fiscal year (FY)*2020 and FY2021. The impact of the pandemic on on-site GCP inspections and the contribution of alternative tools to overall GCP activities** were described. ResultsBetween April 13, 2020, and September 30, 2021, FDA conducted 77 GCP evaluations using alternative tools. Alternative tools were used most commonly for GCP evaluations of non-U.S. clinical investigators in support of mission critical, original New Drug Applications (NDAs). FDA conduced 370 on-site GCP inspections in FY2020 and 451 in FY2021, which represented a 23% and 6% decrease, respectively, compared to the yearly average of 481 on-site GCP inspections in the 5 years preceding the pandemic. The use of alternative tools contributed 10% and 8% to total GCP activities in FY2020 and FY2021, respectively.ConclusionGCP evaluations using alternative tools have played a significant role in GCP activities supporting the review of marketing applications during the COVID-19 public health emergency. KeywordsCOVID-19 pandemic, public health emergency, remote regulatory assessment (RRA), good clinical practice, remote inspection, FDA. *Fiscal year is defined as from October 1 to September 30.**GCP activities in this paper refers to on-site inspections and GCP evaluations using alternative tools conducted by the Office of Regulatory Affairs or the GCP Assessment Branch in the Division of Clinical Compliance Evaluation in the Office of Scientific Investigations in support of marketing applications submitted to the Center for Drug Evaluation and Research at FDA.
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