Regulatory Authorities In Order Research Articles

Labels and package inserts – A study to determine if official guidelines are being followed by pharmaceuticals in India

Background: A package insert is a document within a medication package that provides information about the product. Labels similarly covey information regarding the product but are printed on the packaging rather than separately within. Aims and Objectives: This study aimed to determine whether pharmaceuticals in India adhere to the national guidelines laid down by CDSCO with regards to the packaging and labeling of drugs. Materials and Methods: 100 drugs (labels + package inserts) were collected within duration of 1 month, beginning June 6th, 2023,–July 5th, 2023, from the central drug store of a tertiary care government hospital and nearby pharmacies. After entering pertinent data into a Microsoft Excel sheet, analysis was carried out using descriptive statistics. Results: Most companies (in and around 70%) followed requirements with respect to drug labels barring “warning about the drug” and use of the “red line,” while package inserts showed divisive results, with patient-centric information such as posology, special warnings, and contraindications being followed by more than 80% of the manufacturer’s while taking a backseat with regards to technical details such as shelf life and incompatibilities. Conclusion: Labels and package inserts do largely convey the information that they intend to, with scope for improvement from both companies and regulatory authorities in order to perfect the balance of information conveyed.

Ownership Structure and Earnings Management in View of Effective Monitoring and Myopic Institutions Hypothesis: A Dynamic Panel Estimation

The current research envisages the ownership structure and earnings management nexus in the context of the effective monitoring hypothesis and myopic institutions hypothesis. The ownership aspects, including, shareholdings by the management, institutions, foreign institutions, pension funds, investment companies, and mutual funds are analyzed. The study follows Kothari et al. (2005) for the estimation of discretionary accruals and applied Arellano and Bond dynamic panel estimation to test the models based on a sample of 206 non-financial firms over the period of 2015–2019. The results of the study supported the agency theory, effective monitoring hypothesis, and myopic institutions hypothesis. Consistent with the previous empirical studies, the results reveal that managerial and institutional ownership curtails earnings management practices and discourages myopic management. Furthermore, the analysis of institutional investors based on their investment objectives reveals that the ownership of pension funds and investment companies restrains earnings management practices. On the other hand, discretionary accruals increase monotonically due to the existence of ownership by mutual funds. Furthermore, the study also provides a beer insight to regulatory authorities in order to design policies in such a way that ensures the protection of minority shareholders.

Green Finance as an Institutional Mechanism to Direct the Belt and Road Initiative towards Sustainability: The Case of China

China’s Belt and Road Initiative (hereinafter BRI) has been challenged due to its failure to promote long-term environmental sustainability. Recent years, however, have witnessed a tendency in which green finance is being deliberately crafted by Chinese regulatory authorities in order to support a green BRI. Despite BRI’s popularity as a scientific research topic, the legal literature with regard to China’s domestic green finance laws/regulations and their impact on BRI’s sustainability is insufficient. The purpose of this study is to fill this research gap by examining how China has utilized green finance as an institutional mechanism in order to steer the BRI toward sustainability, as well as to provide policy suggestions on how to further improve BRI’s sustainability by addressing existing legal and regulatory deficiencies. The methodology utilized was a textual analysis of legal/regulatory documents. Based on an investigation of the environmental sustainability challenges faced by the BRI, this paper elaborates Chinese banks’ green finance practices in facilitating a sustainable BRI. It makes a further inquiry into the regulatory instruments by which Chinese banks are able improve their green performances, and elucidates existing regulatory deficiencies. Finally, it presents policy recommendations intended to enhance the ability of Chinese banks to obtain more private capital to finance BRI green projects, including: (1) introducing ‘green’ provisions to the draft Commercial Bank Law; (2) developing a mutually recognized green standard; (3) mandating environmental disclosures; and (4) encouraging institutional investors to buy green assets.

Cytochrome P450 enzymes in the pediatric population: Connecting knowledge on P450 expression with pediatric pharmacokinetics.

Cytochrome P450 enzymes play an important role in the pharmacokinetics, efficacy, and toxicity of drugs. Age-dependent changes in P450 enzyme expression have been studied based on several detection systems, as well as by deconvolution of in vivo pharmacokinetic data observed in pediatric populations. The age-dependent changes in P450 enzyme expression can be important determinants of drug disposition in childhood, in addition to the changes in body size and the other physiological parameters, and effects of pharmacogenetics and disease on organ functions. As a tool incorporating drug-specific and body-specific factors, physiologically-based pharmacokinetic (PBPK) models have become increasingly used to characterize and explore mechanistic insights into drug disposition. Thus, PBPK models can be a bridge between findings from basic science and utilization in predictive science. Pediatric PBPK models incorporate additional system specific information on developmental physiology and ontogeny and have been used to predict pharmacokinetic parameters from preterm neonates onwards. These models have been advocated by regulatory authorities in order to support pediatric clinical trials. The purpose of this chapter is to highlight accumulated knowledge and findings from basic research focusing on P450 enzymes, as well as the current status and future challenges of expanding the utilization of pediatric PBPK modeling.

De-risking Clinical Trials: The BIAL Phase I Trial in Foresight.

De-risking Clinical Trials: The BIAL Phase I Trial in Foresight.

Commercial Real Estate Loans - Categorization of an Investment Segment

Commercial real estate loans (CREL) are a modern essential business segment and of major relevance to the financial stability of an economy as they interconnect the financial markets and the real economy. Consequently, CREL are of specific interest to regulatory authorities. As far as the author knows, there exists no universal definition of CREL in the global financial industry and the regulatory environment. This has been subject to criticism due to resulting gaps and bias in data generated by regulatory filing. This study contributes to academia and applied sciences by providing the missing link. It develops a comprehensive categorization of CREL on a foundation of 34 sources predominately provided by regulatory authorities in the US and the EU. The categorization is based on a qualitative synthesis of main CREL characteristics of this particular heterogeneous asset class outlined in the detected sources. The objective of this work is to support the development of a common understanding of this investment segment among banks, institutional investors and regulatory authorities in order to allow an accurate and prompt filing.

The Entry Lag of Innovative Drugs in Russia, 2010-2019.

Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

Information System for Tablets Identification (ISTI)

Introduction This study aims to develop a software application (App) for the identification of drugs of abuse from visual information retrieved from pills: Information System for Tablets Identification (ISTI). The consumption of anxiolytics and hypnotics, in particular, benzodiazepines (BZD) and similar products, as reached record levels in Portugal, with 10.5 million packages of these products being sold in 2018 [1]. The high prescription of BZD presents a risk to public health [2,3]. An Information system like ISTI will provide an enormous importance on pills’ identification at crime scenes (e.g. homicidal attempts) or premeditated intoxications [4,5]. Materials and methods Tablets from benzodiazepine derivates (ATC codes: N05BA; national pharmacotherapeutic classification: 2.9.1. Anxiolytic, sedatives and hypnotics) were purchased from portuguese pharmacies. In the database were introduced the commercial name, the active substance name, the dose and also photographs were taken from the front, back and side and several physical characteristics of each pill were determined, namely: shape, surface elevation, logo and imprint description, break line, colour, coating, diameter, thickness, weight, horizontal, vertical and side view. The ISTI core is an identification algorithm targeted to matching results by score. The application is being prepared in a way that can either be accessed from a computer or from a mobile device. If economically viable, an image search and request by the users algorithm will be included, so that a photo can be an input, in a query which may prove particularly important to field in the future work. Furthermore, the system is being designed to be easily maintained, through a simple backoffice, and if necessary, agreements will be proposed to national regulatory authorities in order to assure that its data is effectively up to date. Results The prototype developed application allows us to identify pills that may possibly be lost or out of their original packaging. This identification is made through a wide range of tablet features. The person who wants to identify a pill can access the ISTI and through answers to simple questions can find correspondence with the concerning tablet. Discussion and conclusions: The purpose of ISTI is to help health technicians, like doctors, nurses and pharmacists, and agents of authority to identify medicines pills which are not inside the original packaging. Although in the USA there are several Apps with the same objective, to the best of the authors knowledge, ISTI is the first App with this purpose in Portugal.

Do Macroeconomic Variables Predict Deposit Money Banks’ Performance in Nigeria?

This study investigated the relationship between macroeconomic variables and the performance of deposit money banks in Nigeria, analyzed with suitable finametric tools. The results of the empirical examination found that all the macroeconomic variables employed (economic growth rate, interest rate, inflation rate, money supply and exchange rate in this study have no significant relationship with bank performance. It was also observed that each and jointly, the macroeconomic variables do not cause bank performance both in the short run and long run. Again, that bank performance responds insignificantly to the shocks of all the macroeconomic variables. Consequently the researchers advocate that deposit money banks in Nigeria with inherent discretionary policy be proactive to the monetary and fiscal policies of regulatory authorities in order to enhance their performance.

Do Macroeconomic Variables Predict Deposit Money Banks’ Performance in Nigeria?

This study investigated the relationship between macroeconomic variables and the performance of deposit money banks in Nigeria, analyzed with suitable finametric tools. The results of the empirical examination found that all the macroeconomic variables employed (economic growth rate, interest rate, inflation rate, money supply and exchange rate in this study have no significant relationship with bank performance. It was also observed that each and jointly, the macroeconomic variables do not cause bank performance both in the short run and long run. Again, that bank performance responds insignificantly to the shocks of all the macroeconomic variables. Consequently the researchers advocate that deposit money banks in Nigeria with inherent discretionary policy be proactive to the monetary and fiscal policies of regulatory authorities in order to enhance their performance.

Do Macroeconomic Variables Predict Deposit Money Banks’ Performance in Nigeria

This study investigated the relationship between macroeconomic variables and the performance of deposit money banks in Nigeria is incited by the heated arguments of finance and economic researchers’ on whether macroeconomic variables; Gross Domestic Product rate, interest rate, inflation rate, money supply and exchange rate are or not in control of the banks’ management banking sector. Based on that, researchers in this study want to take a solid position on whether macroeconomic variables positively or negatively or of no effect on the performance of deposit money banks (DMBs) in Nigeria. The study made use of suitable finametrica tools to analyze the models. The results of the Error Correction Model and General Method Moments results that all the macroeconomic variables employed (economic growth rate, interest rate, inflation rate, money supply and exchange rate in this study have no significant relationship with bank performance. VECG ranger Causality/Block Exogeneity Wald Test observed that each and jointly, the macroeconomic variables do not cause bank performance both in the short run and long run. Again, impulse response result revealed that bank performance responds insignificantly to the shocks of all the macroeconomic variables. Consequently the researchers advocate that deposit money banks in Nigeria within herent discretionary policy be proactive to the monetary and fiscal policies of regulatory authorities in order to enhance their performance.

Различия в инструкциях как причина ошибок при применении лекарственных препаратов

Contradictions in drug labeling texts for various medicinal products with the same active substance can cause medication errors. We found discrepancies in the Russian drug labeling texts for cefotaxime and oral forms of amoxicillin/clavulanic acid, 500 + 125 mg. We analyzed Russian database of spontaneous reports. In 18.5% spontaneous reports with cefotaxime as a suspected drug and in 22.0% spontaneous reports with amoxicillin/clavulanate in forms for oral administration as a suspected drug we detected medication errors resulted from deviations from those items of approved drug labels which were not harmonized for different drug manufacturers. Such problems require the participation of regulatory authorities in order to eliminate existing discrepancies.

Nutraceuticals and skin appearance: Is there any evidence to support this growing trend?

AbstractThe rise of the nutraceutical market, specifically oral nutrition supplements claiming to improve skin appearance, is striking. This paper aims to examine the published scientific evidence for beneficial effects of nutraceuticals on skin appearance. An overview of skin physiology and intrinsic and extrinsic ageing is provided which underlies the potential physiological processes nutraceuticals purport to counter. Common ingredients used are explored. Some of these (vitamins A, C, B2, B3, B7, copper, iodine, zinc) have authorised skin‐related health claims, but many do not. Current evidence for those without existing authorised claims (e.g. green tea extract, pomegranate extract, carotenoids, evening primrose oil, borage oil, fish oil, collagen and co‐enzyme Q10) is reviewed, focussing primarily on evidence from randomised controlled trials where available, in relation to skin parameters including wrinkles and hydration. Issues of safety are also considered, and the postulated mechanisms for some emerging ingredients, such as cocoa flavanols and probiotics, are explored. Evidence from high quality human trials demonstrating clear benefit is required by regulatory authorities in order for foods and nutrition supplements to carry a health or beauty claim. To date, the evidence for many ingredients in relation to skin appearance is limited, not sufficiently robust and/or inconsistent. Although there are a small number of human studies suggesting a potential benefit and some plausible biological mechanisms, much of the evidence to date comes from animal and in vitro studies. There are simply not enough good quality randomised controlled trials in this area to draw firm conclusions about the benefit of nutraceuticals to skin appearance.

Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial.

Container closure integrity (CCI) testing is required by different regulatory authorities in order to provide assurance of tightness of the container closure system against contamination, for example, by microorganisms. Microbial ingress CCI testing is performed by incubation of the container closure system with microorganisms under specified testing conditions. Physical CCI uses surrogate endpoints, such as coloration by dye solution ingress or gas flow. In order to correlate microbial ingress CCI and physical CCI test methods and to evaluate the methods' capability to detect a given leak, artificially created defects (artificial leaks) are being introduced into the container closure system in a variety of different ways. In our study, artificial leaks were generated using inserted copper wires between the glass vial opening and rubber stopper. Up to date, the insertion of copper wires introduced leaks of unknown size and shape. With nonlinear finite element simulations, the effective aperture size between the rubber stopper and the glass vial was calculated, depending on wire diameter and capping force, and the leak shape was modelled. Our results suggest that the size as well as the shape of the artificial leaks should be taken into account when evaluating critical leak sizes, as flow rate does not, independently, correlate to the hole size.

Is manual therapy efficacious for the treatment of rotator cuff tendinopathy: a systematic review and meta-analysis

sion conducted in 2012–2013 enabled the updating of the original 30 countries and the addition of 8 new countries for publication in 2014. The information is objective and applicable to all physiotherapists worldwide. A description of the initial education has been added to the profile of each country. The survey highlights that in some countries, additional studies are required to obtain a practice licence. The equivalence between degrees is part of the assessment by the national regulatory authority and description of career path, skills and other knowledge of the candidate bring added value. Conclusion(s): In an environment where information is widely scattered, this guide provides an initial response to the lack of transparency and provides access to this information to all physiotherapists. Both versions published (4500 and 6000 copies respectively) were published and distributed to all French physiotherapists and new graduates. International distribution of this guide is essential. An English version is in preparation. Our goal is to provide comprehensive information over a broader spectrum of countries. Implications: This guide is intended as a tool for the promotion and facilitation of meetings and exchanges between professionals for the development of physiotherapy. Information collected shows that international collaborations are possible between regulatory authorities in order to facilitate international mobility of physiotherapists.

Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review.

Potential genotoxic impurities in pharmaceuticals at trace levels are of increasing concern to both pharmaceutical industries and regulatory agencies due to their possibility for human carcinogenesis. Molecular functional groups that render starting materials and synthetic intermediates as reactive building blocks for small molecules may also be responsible for their genotoxicity. Determination of these genotoxic impurities at trace levels requires highly sensitive and selective analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical research and development. Experimental guidance for the analytical determination of some important classes of genotoxic impurities is still unavailable in the literature. Therefore, the present review explores the structural alerts of commonly encountered potential genotoxic impurities, draft guidance of various regulatory authorities in order to control the level of impurities in drug substances and to assess their toxicity. This review also describes the analytical considerations for the determination of potential genotoxic impurities at trace levels and finally few case studies are also discussed for the determination of some important classes of potential genotoxic impurities. It is the authors' intention to provide a complete strategy that helps analytical scientists for the analysis of such potential genotoxic impurities in pharmaceuticals.

A Large‐Scale Empirical Evaluation of Cross‐Validation and External Test Set Validation in (Q)SAR

(Q)SAR model validation is essential to ensure the quality of inferred models and to indicate future model predictivity on unseen compounds. Proper validation is also one of the requirements of regulatory authorities in order to accept the (Q)SAR model, and to approve its use in real world scenarios as alternative testing method. However, at the same time, the question of how to validate a (Q)SAR model, in particular whether to employ variants of cross-validation or external test set validation, is still under discussion. In this paper, we empirically compare a k-fold cross-validation with external test set validation. To this end we introduce a workflow allowing to realistically simulate the common problem setting of building predictive models for relatively small datasets. The workflow allows to apply the built and validated models on large amounts of unseen data, and to compare the performance of the different validation approaches. The experimental results indicate that cross-validation produces higher performant (Q)SAR models than external test set validation, reduces the variance of the results, while at the same time underestimates the performance on unseen compounds. The experimental results reported in this paper suggest that, contrary to current conception in the community, cross-validation may play a significant role in evaluating the predictivity of (Q)SAR models.

Challenges to successful seismic retrofit implementation: a socio-behavioural perspective

Seismic retrofit implementation has been a major challenge in many earthquake-prone cities. This paper examines why building owners are reluctant to adopt measures to reduce earthquake losses despite advancement in seismic design methods and the enactment of intervening legislative frameworks. A case study approach revealed the socio-behavioural barriers affecting seismic retrofit implementation. Significant barriers identified included the perception of earthquake risks, a lack of trust in seismic strengthening techniques and a lack of support for pro-social mitigation behaviours from public authorities. The findings suggest that a reappraisal of the policy implementation approach used by government agencies is required, and that greater attention should be given to seismic designs recommended by professionals and approved by regulatory authorities in order to earn building owners' trust regarding the efficacy of earthquake risk-reduction measures. La mise aux normes parasismiques des constructions existantes est un défi majeur dans de nombreuses villes sujettes aux tremblements de terre. Le présent article examine pourquoi les propriétaires d'immeubles sont peu disposés à adopter des mesures permettant de réduire les sinistres dus aux tremblements de terre en dépit des progrès réalisés dans les méthodes de conception parasismique et malgré la promulgation de cadres législatifs d'intervention. Une approche par étude de cas a mis en évidence les barrières sociocomportementales affectant la mise en œuvre des normes parasismiques dans les immeubles existants. Ont été identifiés parmi ces obstacles importants la perception des risques de tremblements de terre, un manque de confiance dans les techniques de renforcement parasismique et un manque de soutien de la part des autorités publiques en faveur de comportements pro-sociaux permettant d'adoucir ces politiques. Les résultats obtenus suggèrent qu'il est nécessaire d'opérer une réévaluation de l'approche utilisée par les organismes publics pour mettre en œuvre ces politiques, et qu'il devrait être porté une plus grande attention aux conceptions parasismiques recommandées par les professionnels et homologuées par les organismes de réglementation de façon à gagner la confiance des propriétaires d'immeubles, s'agissant de l'efficacité des mesures de réduction des risques liés aux tremblements de terre. Mots clés: propriétaires d'immeubles, prise de décision, immeubles sujets aux tremblements de terre, politique publique, perception des risques, mise aux normes parasismiques, comportement des parties prenantes

Towards targeting platelet storage lesion-related signaling pathways.

Blood platelets play a pivotal role in thrombosis and haemostasis. Platelet transfusions are life-saving medical procedures for patients undergoing major surgery or suffering from diseases such as cancer or thrombocytopenia. Research efforts in transfusion science are applied to the banking of platelets in areas ranging from donor genotyping to the improvement of the blood component processing procedure and determination of product quality. After production, platelet concentrates are stored at room temperature (20–24 °C) with agitation for only 4–7 days. This shelf-life restriction is imposed by health regulatory authorities in order to ensure safety and quality of the blood product owing to the risk of bacterial growth and the loss of platelet viability during storage commonly referred to as the “platelet storage lesion” (PSL).

Financial Crises and Regulatory Response

This paper focuses on the nature and intensity of regulatory responses to crises. It highlights the role of mediation played by capital markets and banks in transmitting the action to economic and the time effect this intermediation activity as on the final outcome. In this context, we argue that actions undertaken both by regulatory authorities in order to encounter a financial crisis are subject to lag-structures which in turn are (negatively) correlated with the intensity level of undertaken actions. Intensity of regulatory activity in turn is a function of actions undertaken by regulatory authorities in order to encounter a crisis. We show that a higher degree of intensity with regard to regulatory responses is not always positively correlated with better economic conditions. On the basis of 38 different crises (1990-2003) we find empirical prove that different intensity levels of crisis-response strategies indeed lead to different economic scenarios also impacting lag structures of economic variables in the wave of a crisis. However, response strategies seem additionally to display some learning effects within a country that has already suffered a crisis recently, leading to the then applied measures being the minimum from which response strategies are gradually escalated. Our main contribution stresses that the response in times of crisis is not only more intense, but interestingly (and somewhat contra dictionary to the increased intensity) requires longer lime lags to become effective. Liquidity arguments and velocity of the monetary transmission system thereby do not seem to be the crucial elements that mitigate these effects. Second round effects and disruptions in the financial intermediation system rather than at central bank level might thus need to be given additional attention in future research.