Clinical research on new drugs (Phase I). Profile of scientific publications: data from the pre-clinical phase and bioethical aspects

OBJETIVO: Traçar o perfil das publicações científicas de fase I e procurar saber se a publicação oferece dados da fase pré-clínica com ênfase nos aspectos bioéticos. MÉTODOS: Foram analisados 61 artigos científicos publicados no ano de 2007, que relatam pesquisas envolvendo seres humanos com novos fármacos, medicamentos ou vacinas em fase I. Foi elaborado um roteiro para coleta de dados, com o qual fosse possível analisar e avaliar os artigos científicos. O roteiro contempla itens referentes à fase pré-clínica (associados à fase clínica) e itens referentes às características da amostra. RESULTADOS: Nos artigos analisados, a maioria das pesquisas foi realizada nos EUA. Devido ao grande número de publicações destinadas às doenças oncológicas a maioria delas foi realizada com voluntários doentes. Quanto às informações sobre a fase pré-clínica presente nas publicações de fase I observamos que são pobres ou inexistentes. Mesmo que os autores julguem a pesquisa fase I como promissora e sugiram estudos futuros de fase II, ao leitor não é possível este mesmo julgamento pela escassez de informações da fase pré-clínica. CONCLUSÃO: O perfil das publicações levanta dados que merecem reflexão e análise para melhor avaliação do que está ocorrendo com as publicações de fase I.

Biochemical profile of the Pêga donkey (Equus asinus) breed: influence of age and sex

Inappropriate reference limits increase the risks of unnecessary investigations and diagnostic failures. Species, breed, environment, handling, and physiologic stage can influence serum biochemical variables. This study aimed to establish serum biochemical reference intervals of Pêga donkeys and the influence of age and sex on these variables. Samples were taken from 110 donkeys (79 females and 31 males; 8 under 1 year, 33 between 1 and 3 years, and 69 over 3 years old). There were no differences for creatine kinase (CK), albumin, urea, and magnesium among age groups. Animals under 1 year old had the lowest aspartate aminotransferase (AST), creatinine, triglycerides, total calcium, and chloride means; lower indirect bilirubin, gamma-glutamyl transferase (GGT), alanine aminotransferase (ALT), and sodium levels than over 3-year-old group and the highest phosphorus, glucose, cholesterol, ionized calcium, and alkaline phosphatase (AP) values. Total protein increased with age. The group from 1 to 3 years had higher potassium than up to 1-year-old group. Animals over 3 years old had the highest means of direct and total bilirubin. ALT, CK, GGT, direct and total bilirubin, urea, triglycerides, sodium, potassium, and chloride levels did not differ between genders. Females had higher AST, total protein, total calcium, and indirect bilirubin levels. Males showed greater AP, albumin, phosphorus, glucose, creatinine, cholesterol, magnesium, and ionized calcium values. Discrepancies among present results and previous studies show influencing factors on biochemical profile of donkeys and reinforce the importance of establishment of specific reference intervals. This study is useful in clinical routine and as basis to other scientific researches with Pêga donkeys. © 2013 Springer-Verlag London.

Texture profile and correlation between sensory and instrumental analyses on extruded snacks

Instrumental texture analysis on extruded snacks is widely applied, however there is no scientific consensus about the test and probe types that can be correlated with the sensory texture of snacks. Eleven commercial extruded snacks of different shapes were evaluated instrumentally using different probes and sensorially through descriptive analysis. The snack texture was described using the attributes of hardness, crispness, adhesiveness, fracturability and chewiness. Cylindrical snacks were described through crispness and fracturability, pelleted and shell-shaped snacks by chewiness and ring-shaped snacks by adhesiveness and hardness. Hardness and adhesiveness were correlated with a Warner-Bratzler test using a V shape probe (r = 0.718 and r = 0.763, respectively), while fracturability and chewiness were correlated with a Warner-Bratzler test using a guillotine (r = 0.776 and r = 0.662, respectively). The fairly strong good correlations enable application of these instrumental tests as an indication of the sensory texture of extruded snacks. © 2013 Elsevier Ltd. All rights reserved.

Exercise domain profile through pulmonary gas exchange response during kendo practice by men

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Petroleum products biodegradation profile similarity evaluated by F test comparison of weekly CO2 production

Strategies applied to bioremediation contaminated environments are necessary to identify limitations towards biodegradation and to predict remediation performance and thereby rule out technologies that may be inappropriate for the clean-up of the substances of concern. Respirometry applied to bioremediation offers a series of advantages for obtaining CO2 production data when compared to other procedures. It was possible to determinate information regarding the atmosphere's CO2 concentration inside a respirometer containing petroleum products. Afterwards, the CO2 data obtained underwent an in depth statistical analysis by F test. There are some noticeable biodegradation similarity among some substances, such as weathered motor oil and gasoline. Such data provides reliability when revealing important information about how the biodegradation processes happens in those residual oils.