Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?

Pharmaceutical equivalence is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. The aim of this paper is to compare traditional difference testing to two one-side equivalence tests in the assessment of pharmaceutical equivalence, by means of equivalence studies between similar, generic and reference products of acyclovir cream, atropine sulfate injection, meropenem for injection, and metronidazole injection. All tests were performed in accordance with the Brazilian Pharmacopeia or the United States Pharmacopeia. All four possible combinations of results arise in these comparisons of difference testing and equivalence testing. Most of the former did not show significant difference, whereas the latter presented similarity. We concluded that equivalence testing is more appropriate than difference testing, what can make it a useful tool to assess pharmaceutical equivalence in products that will not be tested for bioequivalence.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Evaluation of cisplatin, doxorubicin and paclitaxel inactivation using asepto 75^TM 0.5 %, sodium hypochloride 10 % and sodium thiosulfate 10 % by high performance liquid chromatography (HPLC) and in vitro cytotoxicity test

Antineoplastic agents are considered risk drugs; that is, they can cause harmful effects, such as genotoxicity, carcinogenicity, teratogenicity, as well as fertility alterations, therefore being the exposure of health professionals to these substances considerably worrying. These medicaments must be submitted to physical, chemical and biological analyses, what generates a considerable volume of residues, what also requires treatment. The aim of this work was to evaluate the efficacy of different methods of inactivation concerning cisplatin, doxorubicin and paclitaxel, using high performance liquid chromatography and in vitro cytotoxicity test. The results demonstrated that Asepto 75TM is efficient for chemical and biological inactivation of the three drugs, being the exposure time determinant for cisplatin chemical degradation. Cytotoxicity levels varied from none to slight. In spite of its own degree of cytotoxicity, sodium hypochloride was also effective in the chemical inactivation of the three drugs. Sodium thiosulfate degrader, however, was only effective concerning cisplatin chemical inactivation, presenting no effect on doxorubicin or paclitaxel. The results of the in vitro tests were compatible with those from the chemical evaluation. It can therefore be concluded that the inactivation of cytotoxic drugs prior to waste effectively reduces occupational and environmental risks.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Microbiological assay for apramycin soluble powder

The aim of this study was to validate an agar diffusion method through the parameters linearity, precision and accuracy, to quantify apramycin in soluble powder. The calibration curve of apramycin was constructed by plotting log of concentrations (µg ml-1) versus zone diameter (mm) and shows good linearity in the range of 1.0-4.0 µg ml-1. The precision of the assay was determined by assaying samples at the same day (repeatability - R.S.D. = 2.00%) and on different days (intermediate precision - R.S.D. = 5.06%) and indicate good precision. The accuracy expresses the agreement between the accepted value and the value found. The mean recovery was found to be 100.49 % for apramycin soluble powder. The results indicated that the microbiological assay proposed in this work hold linearity, precision and accuracy being an acceptable alternative method for routine quality control of apramycin in the pharmaceutical dosage form studied.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Global conservation prioritization areas in three dimensions of crocodilian diversity

Crocodilians are a taxonomic group of large predators with important ecological and evolutionary benefits for ecosystem functioning in the face of global change. Anthropogenic actions affect negatively crocodilians' survival and more than half of the species are threatened with extinction worldwide. Here, we map and explore three dimensions of crocodilian diversity on a global scale. To highlight the ecological importance of crocodilians, we correlate the spatial distribution of species with the ecosystem services of nutrient retention in the world. We calculate the effectiveness of global protected networks in safeguarding crocodilian species and provide three prioritization models for conservation planning. Our results show the main hotspots of ecological and evolutionary values are in southern North, Central and South America, west-central Africa, northeastern India, and southeastern Asia. African species have the highest correlation to nutrient retention patterns. Twenty-five percent of the world's crocodilian species are not significantly represented in the existing protected area networks. The most alarming cases are reported in northeastern India, eastern China, and west-central Africa, which include threatened species with low or non-significant representation in the protected area networks. Our highest conservation prioritization model targets southern North America, east-central Central America, northern South America, west-central Africa, northeastern India, eastern China, southern Laos, Cambodia, and some points in southeastern Asia. Our research provides a global prioritization scheme to protect multiple dimensions of crocodilian diversity for achieving effective conservation outcomes

Synthesis and antimicrobial activity of amphiphilic carbohydrate derivatives

N-monoalkylated diamines were synthesised and treated with D-ribonolactone or D-gluconolactone. The resulting aldonamides were evaluated for their antimicrobial activity against S. aureus, E. coli, M. tuberculosis and C. albicans. Two hydrazides were also prepared from ribonohydrazide and their biological activity was compared to their amide analogues. All the ribono-derivatives displayed moderated antitubercular activity, and some of them were also active against S. aureus

Study of the gastroprotective action and healing effects of Kalanchoe pinnata (Lam.) against acidified ethanol- and acetic acid-induced gastric ulcers in rats / Estudo da acção gastroprotectora e dos efeitos curativos de Kalanchoe pinnata (Lam.) contra úlceras gástricas induzidas por etanol acidificado e ácido acético em ratos

Kalanchoe pinnata (Lam.) Pers. (Crassulaceae) is a commonly used species in traditional medicine in Brazil for the treatment of various diseases, including gastric ulcers. This research aims to evaluate the antiulcer aspects of Kalanchoe pinnata leaves. The LD50 value of the hydroethanolic extract (HE) of K. pinnata was 1341.46 mg/kg, after the in vitro cytotoxicity assay. In the phytochemical analysis, several flavonoids were identified in the HE and ethyl acetate fraction (EAF) of K. pinnata. It was verified that the gastroprotective activity of the HE of K. pinnata involved prostaglandins and sulfhydryl compounds. However, the mechanism of gastroprotection of the EAF of K. pinnata is dependent on prostaglandins and nitric oxide. The ulcer healing activity of the HE of K. pinnata was also evaluated. According to the macroscopic results, doses of 200 mg/kg and 400 mg/kg reduced the injury area, with rates of 33% and 39%, respectively, after 7 days of treatment (p <0.05). Histological analysis showed regeneration of the gastric mucosa and re-establishment of the glandular architecture in groups treated with the HE (200 and 400 mg/kg). Antioxidant enzymes (CAT, SOD and GPx) were evaluated in the mechanism of gastric ulcer healing. The results showed that the antiulcerogenic activity was mediated by SOD. The anti-Helicobacter pylori activity was also evaluated; however, the HE did not show anti-H. pylori activity. Analysis of the results suggests that K. pinnata has therapeutic potential against gastric ulcers and that the flavonoids may be linked to the biological effects

Pervasive gaps in Amazonian ecological research

Biodiversity loss is one of the main challenges of our time,1,2 and attempts to address it require a clear un derstanding of how ecological communities respond to environmental change across time and space.3,4 While the increasing availability of global databases on ecological communities has advanced our knowledge of biodiversity sensitivity to environmental changes,5–7 vast areas of the tropics remain understudied.8–11 In the American tropics, Amazonia stands out as the world’s most diverse rainforest and the primary source of Neotropical biodiversity,12 but it remains among the least known forests in America and is often underrepre sented in biodiversity databases.13–15 To worsen this situation, human-induced modifications16,17 may elim inate pieces of the Amazon’s biodiversity puzzle before we can use them to understand how ecological com munities are responding. To increase generalization and applicability of biodiversity knowledge,18,19 it is thus crucial to reduce biases in ecological research, particularly in regions projected to face the most pronounced environmental changes. We integrate ecological community metadata of 7,694 sampling sites for multiple or ganism groups in a machine learning model framework to map the research probability across the Brazilian Amazonia, while identifying the region’s vulnerability to environmental change. 15%–18% of the most ne glected areas in ecological research are expected to experience severe climate or land use changes by 2050. This means that unless we take immediate action, we will not be able to establish their current status, much less monitor how it is changing and what is being lostinfo:eu-repo/semantics/publishedVersio