scholarly journals Comparative Analysis of the QbD Approach in the Pharmaceutical Industry

2019 ◽  
Vol 8 (4) ◽  
pp. 20-26 ◽  
Author(s):  
S. A. Rozhnova ◽  
A. V. Tsypkina
Keyword(s):  
Comparative Analysis ◽  
Drug Development ◽  
Systematic Approach ◽  
New Drugs ◽  
Pharmaceutical Development ◽  
Drug Products ◽  
New Drug ◽  
Eurasian Economic Union ◽  
Pharmaceutical Manufacturers ◽  
Economic Union

Introduction. In the development and introduction of medicines into production, the aim of pharmaceutical manufacturers is to comply with the principle of «Quality-by-Design» (QbD). The International Council for Harmonisation (ICH) has created a number of GxP standards, which have become the regulatory framework for the development of documentation regulating the requirements for the development and production of drug products for countries focused on bringing their products to the world pharmaceutical market. The analysis of the system of regulation of pharmaceutical stages of development of new drugs in the territory of the Eurasian Economic Union was not considered, but for the formation of a systematic approach to the management of the process of pharmaceutical development it is necessary to describe them.Aim. To analyze the possibility of applying the QbD principle to the process of drug development at domestic pharmaceutical enterprises.Materials and methods. Content analysis of scientific publications, system and comparative analysis, sociological methods of research in the field of pharmaceutical development.Results and discussions. Regulatory state requirements to the organization and conduct of drug development procedures are analyzed and described. A number of systemic and sectoral problems typical for domestic pharmaceutical manufacturers in the organization of the development and implementation of new drug products. It is established that one of the main problems for Russian enterprises was the organization of the process as a whole and its individual procedures. To solve the problem of organization of procedures for the development and implementation of new medicines, we formed a methodological support, developed on the basis of a systematic approach and international requirements from the quality system.Conclusion. The main problem identified by the manufacturers is the lack of methodological support for the organization of the processes of pharmaceutical development and the introduction of new drugs in the part of research going to the stage of preclinical and clinical development. The decisions adopted by the Eurasian Economic Union do not affect such aspects of pharmaceutical development regulation as the organization of processes, their management and methodological support aimed at the implementation of the QbD principle. To solve this problem, we have developed guidelines for the implementation of the processes of pharmaceutical development and the introduction of new drug products, which allowed us to apply unified and formalized approaches to their organization. 

Marketing and Pharmaceutical Development

1992 ◽  
Vol 22 (2) ◽  
pp. 221-234
Author(s):  
Maven J. Myers
Keyword(s):  
Cumulative Effect ◽  
Basic Research ◽  
Decision Processes ◽  
New Drugs ◽  
The Political ◽  
Market Demand ◽  
Pharmaceutical Development ◽  
New Drug ◽  
The Cost ◽  
Political Decisions

New pharmaceuticals are developed in response to therapeutic need, scientific feasibility, and market demand. As research and development (R&D) decision processes becomes more sophisticated, marketing input plays a greater role in these decisions. Industry-financed R&D is dependent on basic research financed by government. The political decisions which determine government-financed research are significant determinants of the scientific feasibility of a new drug. Many new drugs offer only minor advantages over existing therapies. The cumulative effect of these minor improvements are significant. In addition, new drugs often increase competition in a market. The Orphan Drug Act has contributed to the marketing of drugs where sufficient market demand may not otherwise exist. While some portion of R&D funds are spent on imitative drugs, the incentive for this use of R&D funds decreases as buyers become more sophisticated and as the cost of marketing a new drug increases.

scholarly journals Legal Framework of Labor Migration Governance in the Eurasian Economic Union and the European Communities: Comparative Analysis

2021 ◽  
Vol 8 (4) ◽  
pp. 573-601
Author(s):  
A. S. Leonov ◽  
I. E. Lisinskaya
Keyword(s):  
Comparative Analysis ◽  
Regional Integration ◽  
Labor Migration ◽  
Legal Framework ◽  
Legal Regulation ◽  
The European Union ◽  
Member States ◽  
Eurasian Economic Union ◽  
Migration Flows ◽  
Economic Union

This article provides a comparative analysis of the legal regulation of labor migration in regional integration organizations: the European Communities (ECs) and the Eurasian Economic Union (EAEU). Methodologically, we argue that a synchronous comparison of the European Union (EU) in its current shape and the EAEU is rather inadequate and draw on a diachronic comparison of labor migration regulation in the EAEU and the ECs. On the one hand, we identify a number of important differences. We show, in particular, that while regulatory mechanisms in the EEC aimed at stimulating new migration flows, in the post-Soviet space mechanisms of regional migration governance provide the existing migration flows with an appropriate normative framework. We also show that in the case of the EAEU, the founding Treaty provided for a number of essential social rights for workers from EAEU Member States, whereas in the EEC these rights appeared at a much later stage. Regulation of labor migration in the EEC and the EAEU also differs in terms of distribution of competencies in this area between national and Community / Union levels. On the other hand, we also find a number of similarities, which hint at dynamics of policy learning. This is, in particular, evident in the development of mechanisms aimed at protection of migrants’ rights. This is also the case of the Agreement on pensions for workers of the EAEU member states, which seems to borrow from the EU experience opting for coordination of Member States’ retirement systems instead of their unification. Overall, some of EEC/EU ‘best practices’ have contributed to important positive developments in the regulation of intra-Union labor migration in the EAEU.

scholarly journals Formation of a New Paradigm of Public Service in the Post-Soviet Eurasian Economic Union Countries (Belarus, Armenia, Kazakhstan and Kyrgyzstan)

2019 ◽  
Vol 29 (2) ◽  
pp. 273-279
Author(s):  
Elena Bakhtairova
Keyword(s):  
Comparative Analysis ◽  
Public Service ◽  
New Paradigm ◽  
Economic Space ◽  
State Institutions ◽  
The Public ◽  
Eurasian Economic Union ◽  
Political Approach ◽  
Economic Union ◽  
The One

The article presents a comparative analysis of the public service organization systems of the partner countries of Russia in the Eurasian Economic Union: Belarus, Armenia, Kazakhstan and Kyrgyzstan. On the one hand, these countries are united by the common Soviet past, and, on the other hand, they are working on the formation of a common economic space, which is indirectly influenced by all the state institutions of these countries, including the Institute of public service. The modern paradigm of public service consists in focusing on the active, technological component as opposed to the traditional political approach. The article describes the conditions for moving away from the current political approach and, on the basis of a comparative analysis of legislation and practice of the organization of public service, concludes how close the countries are to the new paradigm.

scholarly journals University professor: scientific trajectory in the conditions of integration and internationalization

2021 ◽  
pp. 136-144
Author(s):  
I. V. Ershova
Keyword(s):  
Comparative Analysis ◽  
Legal Status ◽  
Labor Mobility ◽  
Negative Impact ◽  
Publication Activity ◽  
Academic Mobility ◽  
Eurasian Economic Union ◽  
University Professor ◽  
Economic Union ◽  
Creative Life

The article considers the concept and the basis of the legal status of a professor of a Russian university. Comparisons with a similar position in France and Germany are given. According to the results of a comparative analysis of legal acts of Russia, Belarus, Armenia, Kazakhstan, Kyrgyzstan, significant differences in scientometric indicators for applicants for the degree of Doctor of Law were revealed. The differences in the criteria for awarding the academic title of professor in the member states of the Eurasian Economic Union are shown. The opinion is expressed about the negative impact of this differentiation on labor mobility and academic mobility. It is concluded that the achievement of scientific indicators is necessary throughout the active creative life of the professor. The tendency of “internationalization” of publication activity is revealed, since the requirements for the availability of publications indexed in international databases are present in legal acts regulating various aspects of the professor's activity. It is recommended to take this factor into account when building the scientific trajectory of a modern professor.

scholarly journals International Legal Features of the Constitutional Rights Implementation of the EAEU Member States Citizens in the Field of Pensions

2021 ◽  
Vol 15 (3) ◽  
pp. 66-76
Author(s):  
Yu. V. Mishalchenko ◽  
L. A. Platonova ◽  
A. V. Toropygin
Keyword(s):  
Comparative Analysis ◽  
Union Member ◽  
Social Protection ◽  
Constitutional Rights ◽  
Member States ◽  
Eurasian Economic Union ◽  
Economic Union

This article considers the pension provision of workers of the Eurasian Economic Union member states based on an analysis of the EAEU legislation and a comparative analysis of the domestic pension legislation of the EAEU member states in order to identify the features of their citizens’ social protection in the event of disability. The article discusses the procedure for organizing pensions provision with the application of an Agreement on Pension Provisions for Workers of the EAEU member states of 20 December 2019.

CUSTOMS DUTIES IN THE CUSTOMS UNION OF EURASIAN ECONOMIC UNION

2015 ◽  
Vol 10 (4) ◽  
pp. 133-139 ◽  
Author(s):  
Орлов ◽  
Igor Orlov
Keyword(s):  
Comparative Analysis ◽  
Member State ◽  
Customs Union ◽  
National Legislation ◽  
Eurasian Economic Union ◽  
Economic Union ◽  
Definition Of ◽  
Unambiguous Interpretation

This article presents a comparative analysis of customs duties as a form of customs fees levied in the states - members of the Customs Union Eurasian economic union. Based on the analysis, the suppositions about the reasons for the differences in the bases and the number of customs duties in the states - members of the Customs Union EAEU are made. The author states his position on the need for an unambiguous interpretation of the definition of «customs duties», which will eventually allow to set common types of customs duties in the national legislation of each Member State of the Customs Union EAEU.

The Effect of Price on Pharmaceutical R&D

2009 ◽  
Vol 9 (1) ◽  
Author(s):  
Abdulkadir Civan ◽  
Michael T. Maloney
Keyword(s):  
United States ◽  
Drug Development ◽  
Price Elasticity ◽  
The United States ◽  
Mortality Rates ◽  
New Drugs ◽  
New Drug ◽  
Development Pipeline ◽  
New Drug Development

Abstract This work extends prior research that finds drug development is driven by demand factors such as mortality rates of the diseases new drugs are aimed at. Here we find that the number of drugs in the development pipeline is strongly positively related to the price of existing drugs treating those diseases. This gives us a direct price elasticity measure from which we can draw some inference about the effect on new drug development that might occur if the pricing regime in the United States were to change.

Sign in / Sign up

Export Citation Format

Share Document