ABSTRACT
The purpose of this study was to analyze Moroccan regulations on bioequivalence studies and compare them with someinternational guidelines. It emerged that, as most common guidelines, Moroccan regulations treated essential questionsrelating to the conduct of bioequivalence studies while remaining general. An effort to harmonize the Moroccanregulations as closely as possible with international guidelines such as European Medicines Agency and World HealthOrganization was made. The decree 2-12-198 on bioequivalence studies includes worldwide gold standards such asinclusion and exclusion criteria, study design, choice and number of subjects, conduct of the study, pharmacokineticparameters, BE acceptance criteria, and biowaiver requirements. It specifically addresses issues such as pro-drug,metabolites, urinary samples, and endogenous substances. Specific precisions such as the case of the modified releaseforms, the replacement of subjects on the withdrawal, or drop-out of a volunteer are not covered by this general decreeand should be part of new directives, in the future. For an emerging country, the integration of BiopharmaceuticsClassification System biowaivers within the decree confirms the efforts being made by the Moroccan regulations tojoin the most advanced guidelines on the investigation of bioequivalence and to prepare the International Council onHarmonisation M9 adoption
ABSTRACT
Abstract Echinoderms have attracted the attention of scientists over the past few years after identifying a variety of unique structures endowed by interesting biological properties. However, the Moroccan coast biodiversity is still uninvestigated. In our ongoing attempts to valorize the rich Moroccan marine environment, this study aimed at assessing the antimicrobial activity of extracts obtained from three echinoderms Astropecten irregularis, Luidia sarsi and Ophiura albida against the human pathogens: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica and Bacillus subtilis. Moreover, their antioxidant activities were tested using standard methods in addition to the antidiabetic activity which has been evaluated in vitro against α-amylase and α-glucosidase enzymes. HPLC-DAD-QTOF-MS analysis revealed a significant content of some phenolic compounds such as pyrogallol, gallic, sinapic, ferulic, p-hydroxybenzoic and salicylic acids whose existence can be related to the endophytic fungi and/or dietary intake whereas GC-MS analysis exhibited diverse chemical structures such as cholesterol, oleic acid and glycerol 1-palmitate.
ABSTRACT
Background: Haemodialysis patients are at risk of developing trace elements imbalance and lipid peroxidation. The present study was aimed to assess plasma levels of copper (Cu), zinc (Zn), selenium (Se) and malondialdehyde (MDA) of haemodialysis patients and to investigate the possible effect of haemodialysis on these trace elements and MDA imbalance. Methods: Blood samples of fifty hemodialysis patients and forty healthy controls subjects were analyzed for determination of hemoglobin, albumin, creatinine, urea and high-sensitivity C-reactive protein (hs-CRP). Cu, Zn and Se were determined in plasma (before and after hemodialysis) and erythrocytes and MDA in plasma before and after hemodialysis. Results: The study showed that, plasma Zn and Se concentrations were lower in haemodialysis patients compared to that of healthy controls, while plasma Cu, MDA and Cu/Zn ratio were higher. Plasma Cu/Zn ratios were positively correlated to MDA and weakly correlated to hs-CRP levels whereas plasma Se concentrations were inversely correlated to MDA. In addition, MDA levels increased after haemodialysis session. Conclusions: Based on the results of the present study regarding the imbalance of trace elements in haemodialysis patients, it seems reasonable to periodically assess the trace elements status and consider possible correctional therapy in case of deficiency.