The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.
As a negative social issue, teenagers’ problem behavior not only affects individuals’ physical and mental health and social function development but is also not conducive to social harmony and stability. This study mainly discusses the influence of academic pressure on adolescents’ problem behavior, and the potential relationship between these and academic pressure, examining issues such as self-control, parent–child conflict, and subjective well-being. The data were collected from the fifth wave of the China Family Panel Studies (2017–2018). The data of 2,465 teenagers aged 10–15 were analyzed by LISREL8.8 software. The results show that academic pressure positively affects adolescents’ deviant behavior. The mediation model finds that parent–child conflict and self-control play a direct mediating role between academic pressure and adolescents’ behavioral problems. Parent–child conflict, self-control, and subjective well-being have important chain mediation effects between academic pressure and adolescents’ problem behavior. Therefore, in order to reduce the risk of such problems, it is necessary to further strengthen individuals’ ability to maintain self-control, promote or cultivate adolescents’ character strengths, create a harmonious family atmosphere, reduce the probability of parent–child conflict, and increase the subjective well-being of teenagers.
The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars are important for health care, as they allow the marketing of safe, efficacious and affordable biological products. Since the first biosimilars were approved in the EU in 2006, a series of biosimilars have been approved in many countries/geographical regions. This manuscript provides the figures on the status of approved biosimilars in 16 countries based on the information from regulatory experts and from publicly available data. It is clear that increasing numbers of biosimilars are now available in many countries and provide more options for treatments. It is expected that adoption of biosimilars will allow affordable health care and greater patient access to important medicinal products. It will also contribute to the overall WHO goal recognized by the World Health Assembly in 2014 by adopting a resolution on access to biotherapeutic products including biosimilars and on ensuring their quality, safety and efficacy.
As an important part of energy saving and carbon reduction, the low-carbon development of the transportation industry is imperative. It is the responsibility of smart transportation enterprises to closely combine their own digital technology with the governments’ policies to achieve green innovation. In this study, we conducted an evolutionary game model of the interaction between the governments and smart transportation enterprises, which depended on innovation subsidies and punitive taxes. Besides, we derived the evolutionarily stable strategy of the governments and enterprises and used a simulation to analyze the impact of various policy tools on green innovation strategy. The results showed that the behavior of the governments relies on the benefits of supervision and the costs of supporting green technology innovation. The enterprises’ behavior depends on the benefits of green innovation and the loss of no green innovation. Moreover, different policy tools provided by the governments can accelerate the implementation of enterprises’ green innovation.
Severe tour guide stigma is a significant problem hindering tourism development. Based on self-identity threat and moral disengagement theory, this study analyzed the relationship between tour guide stigmatization and tour guides’ interpersonal deviance behavior. Survey data collected from 241 tour guides at three different points in time showed that tour guide stigmatization was positively related to tour guides’ interpersonal deviance behavior and that self-identity threat mediated this effect. The results also show that moral disengagement moderated the effect of tour guides’ self-identity threat on interpersonal deviance behavior, as well as the indirect effect of tour guide stigmatization on tour guides’ interpersonal deviance behavior via self-identity threat. This study enriches theoretical research on tour guide stigmatization and offers practical suggestions for solving stigmatization problems for tour guides and organizations.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.