Multivariate guard-bands and total risk assessment on multiparameter evaluations with correlated and uncorrelated measured values

Abstract The quality, efficacy, and safety of medicines are usually verified by analytical results. Measurement uncertainty is a critical aspect for the reliability of these analytical results. The pharmacopeial compendia usually adopt a simple acceptance rule that does not consider information from measurement uncertainty. In this work, we compared decision-making using simple acceptance and decision rules with the use of guard-band for multiparameter evaluation of ofloxacin ophthalmic solution and acyclovir topical cream. Ciprofloxacin ophthalmic solution and acyclovir topical cream samples were subject to pharmacopeial tests and assays. Multivariate guard-band widths were calculated by multiplying the standard uncertainty (u) by an appropriate multivariate coverage factor (k'). The multivariate coverage factor (k') was obtained by the Monte Carlo method. According to the simple acceptance rule, all the results obtained for ciprofloxacin ophthalmic solution and acyclovir topical cream are within the specification limits. However, the risk of false conformity decisions increases for ciprofloxacin tests. Decisions made using the simple acceptance rule and decision rules with the use of guard-band may differ. The simple acceptance rule may increase the risk of false conformity decisions when the measured value is close to the regulatory specification limits and/or when the measurement uncertainty value is inappropriately high. Nevertheless, the guard-band decision rule will always reduce the risk of false conformity decisions. Therefore, using information on measurement uncertainty in conformity assessment is highly recommended to ensure the proper efficacy, safety, and quality of medicines.

Invasion risks posed by ornamental freshwater fish trade to southeastern Brazilian rivers

A model was developed to assess the risk of invasion of ornamental non-native fishes to six rivers in the state of Minas Gerais, southeastern Brazil, with focus on species popularity. Thirty-nine aquarium shops, in six cities, were visited monthly from January to December 2007. In each city, fish species were identified, and their biology and invasion history information was obtained from the literature. We calculated the annual frequency of occurrence and average number of specimens monthly available in stores. Quarterly water temperature and dissolved oxygen data from 1997 to 2007 were obtained for the Velhas, Muriaé, Uberabinha, Sapucaí-Mirim, Doce and Todos os Santos Rivers from public databases. The invasion risk of each species was assessed through a model comprising nine parameters grouped in four variables: (i) Invasiveness (thermal and dissolved oxygen ranges, diet, parental care or fecundity), (ii) History of invasions (establishment), (iii) Propagule pressure (commercial success, comprising annual frequency of occurrence and number of specimens available monthly at stores), and (iv) Invasibility (water temperature and dissolved oxygen in the target river compatible with the species ranges). Of the 345 ornamental fish species for sale, 332 are non-native to either Minas Gerais (n = 151) or Brazil (n = 194). Based on the proposed cutting values, in particular the compatibility between species and recipient thermal ranges, five ornamental non-native species (Cyprinus rubrofuscus, Carassius auratus, Xiphophorus hellerii, Poecilia reticulata, and P. latipinna) can potentially invade the Velhas and Muriaé Rivers, four species (Cyprinus rubrofuscus, Carassius auratus, X. helleri, and P. reticulata) the Uberabinha River, four species (Cyprinus rubrofuscus, Carassius auratus, X. maculatus, and P. reticulata) the Sapucaí-Mirim River, three species (Carassius auratus, X. hellerii, and P. reticulata) the Doce River, and three species (Cyprinus rubrofuscus, P. reticulata, and Amatitlania nigrofasciata) can potentially invade the Todos os Santos River. Six recommendations are suggested to reduce the invasion risk of non-native fish on the rivers surveyed posed by aquarium trade.

Um modelo foi desenvolvido para avaliar o risco de invasão de peixes ornamentais não-nativos em seis rios do estado de Minas Gerais, sudeste do Brasil, com foco na popularidade das espécies. Trinta e nove lojas de aquário em seis cidades foram visitadas mensalmente de janeiro a dezembro de 2007. Em cada cidade, as espécies foram identificadas e suas biologias e histórias de invasão foram obtidas da literatura. Calculou-se a frequência de ocorrência anual e quantidade média mensal de exemplares disponíveis nas lojas. Foram obtidas temperaturas trimestrais da água e dados de oxigênio dissolvido de 1997 a 2007 dos rios Velhas, Muriaé, Uberabinha, Sapucaí-Mirim, Doce e Todos os Santos a partir de bases de dados públicas. O risco de invasão de cada espécie foi avaliado através de um modelo composto por nove parâmetros agrupados em quatro variáveis: (i) Invasividade (limite de alcance térmico/oxigênio dissolvido, dieta, cuidado parental ou fecundidade), (ii) Histórico de invasões (estabelecimento), (iii) Pressão de propágulos (sucesso comercial, composto pela frequência de ocorrência anual e número de exemplares disponíveis mensalmente nas lojas), e (iv) Invasibilidade (temperatura da água/oxigênio dissolvido dos rios compatível com o limite de alcance térmico/ oxigênio dissolvido das espécies). Das 345 espécies de peixes ornamentais para venda, 332 são não-nativos para Minas Gerais (n = 151) ou Brasil (n = 194). Com base nos valores de corte propostos, cinco espécies de peixes ornamentais não-nativos (Cyprinus rubrofuscus, Carassius auratus, Xiphophorus hellerii, Poecilia reticulata e P. latipinna) podem potencialmente invadir os rios Velhas e Muriaé, quatro espécies (C. rubrofuscus, C. auratus, X. helleri, P. reticulata) podem ...

La medición de la conducta suicida en México: estimaciones y procedimientos / The measurement of suicide behavior in Mexico: estimates and procedures

Este es un análisis de los resultados de varios estudios en diferentes poblaciones de México sobre el intento y la ideación suicida, en el que se utilizaron diferentes metodologías e instrumentos para medirlos. En su mayoría, estos fueron encuestas representativas de muestras de hogares y escuelas, así como, estudios en escenarios clínicos.La prevalencia más alta de intento de suicidio fue de 10 por ciento. La prevalencia de ideación suicida más alta fue de 40.7 por ciento. Se encontraron diferencias importantes en los instrumentos utilizados para medir la conducta suicida y su temporalidad, y en los puntos de corte utilizados para definir los casos. Este análisis de la información nos permitirá obtener datos más precisos sobre el intento y la ideación suicida en la población mexicana, los cuales son muy importantes para diseñar las políticas de salud. Unificando los criterios de los investigadores, se contará con mejores registros sobre el intento y la ideación suicida.

Evaluación conjunta del programa nacional de control de tuberculosis: Bolivia, 11-21 de octubre de 1999 / Joint evaluation of the national program for tuberculosis control: Bolivia, 11-21 of October 1999

La tuberculosis es una enfermedad de extrema gravedad que afecta al país de forma endémica, es prevenible y de fácil control, sin embargo es la causa más importante de mortalidad producida por un solo agente en el ámbito nacional. La presente evaluación muestra que el Programa Nacional de Control de Tuberculosis(PNT) tiene una distribución a nivel nacional que es irregular y de mayor importancia en áreas densamente pobladas y con condiciones de hacinamiento y desnutrición, es así que el 76 por ciento del total de los casos diagnosticados se encuentran en los departamentos de La Paz, Santa Cruz y Cochabamba. Así que el PNT solo logra una cobertura en la localización de casos del 60 por ciento y solo alcanza a curar el 70 por ciento de los enfermos que inician tratamiento, con tasas de deserción por encima del 15 por ciento con actividades mínimas de control del entorno del paciente y menos aun la utilización de la quimioprofiláxis de casos de riesgo