Building risk mitigation strategies for circularity adoption in Indian textile supply chains.

Textile industries are among the most polluting and demand urgent management measures to mitigate their negative environmental impact. Thus, it is imperative to incorporate the textile industry into the circular economy and to foster sustainable practices. This study aims to establish a comprehensive, compliant decision framework to analyse risk mitigation strategies for circular supply chain (CSC) adoption in India's textile industries. The Situations Actors Processes and Learnings Actions Performances (SAP-LAP) technique analyses the problem. However, interpreting the interacting associations between the SAP-LAP model-based variables is somewhat lacking in this procedure, which might skew the decision-making process. As a result, in this study, the SAP-LAP method is accompanied by a novel ranking technique, namely, the Interpretive Ranking Process (IRP), which reduces decision-making issues in the SAP-LAP method and aids in evaluating the model by determining the ranks of variables; furthermore, the study also offers causal relationships among the various risks and risk factors and various identified risk-mitigation actions by constructing Bayesian Networks (BN) based on conditional probabilities. The study's originality represents the findings using an instinctive and interpretative choice approach to address significant concerns in risk perception and mitigation techniques for CSC adoption in the Indian textile industries. The suggested SAP-LAP and the IRP-based model would assist firms in addressing risk mitigation techniques for CSC adoption concerns by providing a hierarchy of the various risks and mitigation strategies to cope with. The simultaneously proposed BN model will help visualise the conditional dependency of risks and factors with proposed mitigating actions.

COVID19 epidemic outbreak: operating rooms scheduling, specialty teams timetabling and emergency patients' assignment using the robust optimization approach.

The health care system is characterized by limited resources, including the physical facilities as well as skilled human resources. Due to the extensive fixed cost of medical facilities and the high specialization required by the medical staff, the problem of resource scarcity in a health care supply chain is much more acute than in other industries. In the pandemic of the Coronavirus, where medical services are the most important services in communities, and protective and preventive guidelines impose new restrictions on the system, the issue of resource allocation will be more complicated and significantly affect the efficiency of health care systems. In this paper, the problem of activating the operating rooms in hospitals, assigning active operating rooms to the COVID-19 and non-COVID-19 patients, assigning specialty teams to the operating rooms and assigning the elective and emergency patients to the specialty teams, and scheduling their operations is studied by considering the new constraints of protective and preventive guidelines of the Coronavirus. To address these issues, a mixed-integer mathematical programming model is proposed. Moreover, to consider the uncertainty in the surgery duration of elective and emergency patients, the stochastic robust optimization approach is utilized. The proposed model is applied for the planning of operating rooms in the cardiovascular department of a hospital in Iran, and the results highlight the role of proper management in supplying sufficient medical resources effectively to respond to patients and scheduled surgical team to overcome the pressure on hospital resources and medical staff results from pandemic conditions.

Global food security post COVID-19: Dearth or dwell in the developing world?

Today, global food systems are highly susceptible to food safety risks, economic shocks, price volatility, and natural disasters and pandemics, such as the novel coronavirus (COVID-19). This paper draws from research on food and nutritional security, food fraud and associated economic ecosystem, and the disruptions due to COVID-19 for socio-economic inequality globally. It is concluded that the safety risks have pushed enforcement of measures to reduce food supplies, adversely impacting food availability. Also, COVID-19 is likely to raise fleeting food security and nutritional concerns across the globe, resulting in rises in poverty and food fraud, limiting food supply and access. Accelerated investments intended to develop more inclusive, sustainable, and resilient food systems will help shrink the effect of the pandemic and, hence, offer a way to control the foreseen food security crisis and economic growth.

Role of Average Volume Assured Pressure Support Mode (AVAPS) in the Management of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Type 2 Respiratory Failure.

Background Non-invasive ventilation (NIV) is a well-established approach in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) with type 2 respiratory failure. Average volume-assured pressure support (AVAPS) mode integrates the characteristics of both volume and pressure-controlled modes of NIV. In bilevel positive airway pressure (BiPAP) mode, volume is the dependent variable, whereas in AVAPS mode, pressure is the dependent variable. In this study, we aimed to compare the role of AVAPS mode with BiPAP spontaneous/timed (S/T) mode for the management of patients with acute exacerbation of COPD with type 2 respiratory failure. Methodology A hospital-based comparative and analytical study was carried out on 100 patients with acute exacerbation of COPD with type 2 respiratory failure admitted to respiratory disease hospital, Sardar Patel Medical College, Bikaner (Rajasthan, India). Patients were randomly divided into two groups of 50 patients each. Group A patients were treated with AVAPS mode and group B patients with BiPAP (S/T) mode. Arterial blood gases, average duration of hospital stay, and need for invasive mechanical ventilation were compared between the two groups. Results There was a statistically significant difference in favor of group A in terms of improvement in pH and pCO2 as compared to group B at 6 h (pH, p=0.027; pCO2, p=0.012) and 24 h (pH, p=0.032; pCO2, p=0.013). The duration of hospital stay was found to be lower in group A (p=0.003). However, no significant difference was found in terms of need for invasive mechanical ventilation between both groups (p=0.338). Conclusion Application of AVAPS mode results in more rapid and steady improvement in patients of COPD as compared to BiPAP (S/T) mode. Thus, management through non-invasive ventilation AVAPS mode should be considered in patients with acute exacerbation of COPD with type 2 respiratory failure.

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

Challenges in application of bioanalytical method on different populations and effect of population on PK.

Prashant Kale has 22 years of immense experience in the analytical and bioanalytical domain. He is Senior Vice President, Bioequivalence Operations of Lambda Therapeutic Research, India which includes Bioanalytical, Clinics, Clinical data management, Pharmacokinetics and Biostatistics, Protocol writing, Clinical lab and Quality Assurance departments. He has been with Lambda for over 14 years. By qualification he is a M.Sc. and an MBA. Mr. Kale is responsible for the management, technical and administrative functions of the BE unit located at Ahmedabad and Mumbai, India. He is also responsible for leading the process of integration between bioanalytical laboratories and services offered by Lambda at global locations (India and Canada). Mr. Kale has faced several regulatory audits and inspections from leading regulatory bodies including but not limited to DCGI, USFDA, ANVISA, Health Canada, UK MHRA, Turkey MoH, WHO. There are many challenges involved in the application of bioanalytical method on different populations. This includes difference in equipment, material and environment across laboratories, variations in the matrix characteristics in different populations, differences in techniques between analysts such as sample processing and handling and others. Additionally, there is variability in the PK of a drug in different populations. This article shows the effect of different populations on validated bioanalytical method and on the PK of a drug. Hence, the bioanalytical method developed and validated for a specific population may need required modification when applied to another population. Critical consideration of all such aspects is the key to successful implementation of a validated method on different populations.

Determination of mycophenolic acid in human plasma by high-performance liquid chromatography.

The development, validation and evaluation of high-performance liquid chromatography (HPLC) method for quantifying mycophenolic acid in human plasma is described. The method involved protein precipitation using acetonitrile, after addition of terazosin as an internal standard. Separation was achieved with a reversed-phase C18 column (250 mm x 4.6 mm) employing UV detection at 215 nm. The mobile phase consisted of 0.02 M potassium dihydrogenphosphate solution adjusted to pH 6.9 with 2 M potassium hydroxide solution-acetonitrile (80:20 (v/v)) at a flow rate of 1.5 ml/min. The total run time was 21.0 min. The assay was linear from 0.2 to 25 microg/ml with goodness of fit (r2) greater than 0.99 observed with three precision and accuracy batches during validation. The observed mean recoveries were 89.3 and 98.0% for drug and internal standard, respectively. The applicability of this method to pharmacokinetic studies was established after successful application during a 34-subject bioavailability study. The method was found to be precise, accurate and specific during the study.