An epidemiological study of road traffic accident cases admitted in a tertiary care hospital.

BACKGROUND: Road traffic accidents are a leading cause of mortality and morbidity globally. In India, more than a million are injured annually and about a lakh are killed in road traffic accidents.(1) It causes the country to lose around 55,000 crores annually which is 2-3% of Gross Domestic Production (GDP).(2) This cross sectional study was conducted to elucidate the role of various factors involved in road traffic accidents. METHODS: Road traffic accident cases admitted to a tertiary care hospital between 01 Oct 2009 and 28 Feb 2011 were included in the study. A total of 182 patients were studied. Information was collected through questionnaire, hospital records and on-site visit. OPD cases, comatose patients and deaths were excluded. RESULTS: Two-wheelers were the commonest vehicle involved in vehicular accidents. Most accidents happened at a speed of 40-60 km/h (37.9%). Most of the patients were aged between 20 and 30 years. Majority had a driving experience of less than 5 years. Monsoons witnessed 46.7% cases. Most cases occurred between 6 and 10 pm. Among severe injuries, the commonest was lower limb fractures (19.8%). CONCLUSION: There are multiple factors associated with road traffic accidents which due to the lack of road safety measures in the country are playing their role. It is the need of the hour to address this issue and formulate comprehensive, scientific and practical rules and regulations as well as evaluate its enforcement.

In vitro and in vivo equivalence testing of nanoparticulate intravenous formulations.

The topic of bioequivalence evaluation of nanoparticulate intravenous formulations is one that has been intensely debated in recent times since the release of the specific recommendations by many regulatory authorities worldwide. Product specific bioequivalence guidelines for many of the nanoparticulate systems where therapeutic molecules are directly coupled (human albumin bound paclitaxel nanosuspension), functionalized (iron- carbohydrate preparations) or entrapped/coated to a carrier (doxorubicin liposomal formulations), have been approved by the drug regulatory agencies. These current regulatory procedures include complete characterization of the generic formulation in terms of its physicochemical characteristics, pharmacokinetics disposition and/or non clinical testing with respect to the reference formulation. The concept of in vitro equivalency is emerging as a valuable tool in these guidances as generic product differing in in vitro parameters can result in a different biopharmaceutical profile with respect to pharmacokinetics and biodistribution. Furthermore, in case of systems with entrapped drug, classical pharmacokinetic parameters alone may only ensure the equivalent clearance of test and reference product from systemic circulation but may fail to detect the extent to which the nanoparticles are taken up by different target organs and, consequently, the safety and efficacy effects. Hence, additional tissue distribution study in preclinical study models has reflected in recent guidances. Understanding and interpretation of these regulatory requirements thus presents most critical component of a generic product development cycle. This article reviews these current regulatory procedures with special emphasis on in vitro population bioequivalence (POP BE) and preclinical testing of generic formulations.

The effect of various drugs on maternal serum cystine aminopeptidase.

Serial estimations (87) of serum cystine aminopeptidase (CAP) in pregnant women (18) using diphenyl hydantoin, phenobarbital or diazepam revealed that the enzyme levels were below the average for normals in 89% of patients. The initially low CAP levels in women on diazepam were improved within 24 h after betamethasone administration. Subsequent studies in vitro confirmed that diphenyl hydantoin, phenobarbital, diazepam and acetyl salicylate markedly inhibited CAP levels in sera of women (72) with clinically uncomplicated pregnancy. No inhibition of CAP by any of the drugs tested was observed in sera from nonpregnant women (8). However, nonpregnant women receiving medroxyprogesterone acetate injections showed CAP inhibition by various drugs, suggesting some changes in the enzyme moiety under the influence of the hormone.