Bio-analytical method validation and its importance in pharma research - A review article

Bioanalytical method based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to give confidence in the results generated. It is the process used to establish that a quantitative analytical method is suitable for biomedical applications. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine is reliable and reproducible for the intended use. The present manuscript focuses on the consistent evaluation of the key bioanalytical validation parameters is discussed: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery and stability. These validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and EMA guid

Analysis of the corporate political activity of major food industry actors in Fiji

BACKGROUND: Non-communicable diseases (NCDs) are the leading cause of mortality in Fiji, a middle-income country in the Pacific. Some food products processed sold and marketed by the food industry are major contributors to the NCD epidemic, and the food industry is widely identified as having strong economic and political power. However, little research has been undertaken on the attempts by the food industry to influence public health-related policies and programs in its favour. The "corporate political activity" (CPA) of the food industry includes six strategies (information and messaging; financial incentives; constituency building; legal strategies; policy substitution; opposition fragmentation and destabilisation). For this study, we aimed to gain a detailed understanding of the CPA strategies and practices of major food industry actors in Fiji, interpreted through a public health lens. METHODS AND RESULTS: We implemented a systematic approach to monitor the CPA of the food industry in Fiji for three months. It consisted of document analysis of relevant publicly available information. In parallel, we conducted semi-structured interviews with 10 stakeholders involved in diet- and/or public health-related issues in Fiji. Both components of the study were thematically analysed. We found evidence that the food industry adopted a diverse range of strategies in an attempt to influence public policy in Fiji, with all six CPA strategies identified. Participants identified that there is a substantial risk that the widespread CPA of the food industry could undermine efforts to address NCDs in Fiji. CONCLUSIONS: Despite limited public disclosure of information, such as data related to food industry donations to political parties and lobbying, we were able to identify many CPA practices used by the food industry in Fiji. Greater transparency from the food industry and the government would help strengthen efforts to increase their accountability and support NCD prevention. In other low- and middle-income countries, it is likely that a systematic document analysis approach would also need to be supplemented with key informant interviews to gain insight into this important influence on NCD prevention

Health-based risk targets for fluorosis in tribal children of rural Madhya Pradesh, India

Conventional approaches to fluorosis mitigation and control are based on reduction of excess fluoride consumption from water. Country specific standard limits of 1 mg/l or 1.5mg/l are established and monitored by water departments based on recommendations outlined in the World Health Organization (WHO) Guidelines for Drinking Water Quality (GDWQ). With the advent of the third edition of the WHO GDWQ there is a fundamental departure from standard setting, based on doseresponse affect, towards risk assessment and risk management. The water quality framework, outlined in the guidelines, consists of an iterative cycle, comprising: an assessment of risk, health targets linked to the wider public health context; risk management (with these components being informed by aspects of environmental exposure and acceptable risk) The guidelines advocate for the use of Water Safety Plans, as risk management tool, to help achieve Health Based Risk Targets. This paper presents the application of a Quantitative Chemical Risk Assessment (QCRA) method for determining health based risk targets for fluorosis control. The paper presents evidence from Madhya Pradesh, India. The findings indicate firstly that to control fluorosis total daily consumption from all exposure routes (water and food) must be considered, secondly that the most exposed population group to fluorosis are children due to lack of alternative early nutrients (e.g. exclusive breastfeeding) and, thirdly, that quantifying chemical risk is essential for appropriate risk management strategies to reduce fluorosis in children

Assessment of a Salt Reduction Intervention on Adult Population Salt Intake in Fiji.

Reducing population salt intake is a global public health priority due to the potential to save lives and reduce the burden on the healthcare system through decreased blood pressure. This implementation science research project set out to measure salt consumption patterns and to assess the impact of a complex, multi-faceted intervention to reduce population salt intake in Fiji between 2012 and 2016. The intervention combined initiatives to engage food businesses to reduce salt in foods and meals with targeted consumer behavior change programs. There were 169 participants at baseline (response rate 28.2%) and 272 at 20 months (response rate 22.4%). The mean salt intake from 24-h urine samples was estimated to be 11.7 grams per day (g/d) at baseline and 10.3 g/d after 20 months (difference: -1.4 g/day, 95% CI -3.1 to 0.3, p = 0.115). Sub-analysis showed a statistically significant reduction in female salt intake in the Central Division but no differential impact in relation to age or ethnicity. Whilst the low response rate means it is not possible to draw firm conclusions about these changes, the population salt intake in Fiji, at 10.3 g/day, is still twice the World Health Organization's (WHO) recommended maximum intake. This project also assessed iodine intake levels in women of child-bearing age and found that they were within recommended guidelines. Existing policies and programs to reduce salt intake and prevent iodine deficiency need to be maintained or strengthened. Monitoring to assess changes in salt intake and to ensure that iodine levels remain adequate should be built into future surveys

An In Vitro Model for Lewy Body-Like Hyaline Inclusion/Astrocytic Hyaline Inclusion: Induction by ER Stress with an ALS-Linked SOD1 Mutation

Neuronal Lewy body-like hyaline inclusions (LBHI) and astrocytic hyaline inclusions (Ast-HI) containing mutant Cu/Zn superoxide dismutase 1 (SOD1) are morphological hallmarks of familial amyotrophic lateral sclerosis (FALS) associated with mutant SOD1. However, the mechanisms by which mutant SOD1 contributes to formation of LBHI/Ast-HI in FALS remain poorly defined. Here, we report induction of LBHI/Ast-HI-like hyaline inclusions (LHIs) in vitro by ER stress in neuroblastoma cells. These LHI closely resemble LBHI/Ast-HI in patients with SOD1-linked FALS. LHI and LBHI/Ast-HI share the following features: 1) eosinophilic staining with a pale core, 2) SOD1, ubiquitin and ER resident protein (KDEL) positivity and 3) the presence of approximately 15–25 nm granule-coated fibrils, which are morphological hallmark of mutant SOD1-linked FALS. Moreover, in spinal cord neurons of L84V SOD1 transgenic mice at presymptomatic stage, we observed aberrant aggregation of ER and numerous free ribosomes associated with abnormal inclusion-like structures, presumably early stage neuronal LBHI. We conclude that the LBHI/Ast-HI seen in human patients with mutant SOD1-linked FALS may arise from ER dysfunction

Atmospheric Dry Deposition on Leaves at an Urban Location

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