scholarly journals Correlation of reference and generic fluconazole-based drugs

2020 ◽  
pp. 98-104
Author(s):  
A. S. Dukhanin
Keyword(s):  
Generic Drugs ◽  
Medical Community ◽  
Quantitative Composition ◽  
Therapeutic Equivalence ◽  
Efficacy And Safety ◽  
Federal Law ◽  
Reference Drug ◽  
State Register ◽  
The Law ◽  
Preclinical And Clinical Studies

The article describes the basic rules for the selection of a systemic antifungal drug from the fluconazole-based preparations available on the Russian pharmaceutical market. Questions of interchangeability of generic and original drugs, research of equivalence (pharmaceutical, pharmacokinetic), possible methodological difficulties of its estimation are discussed. Data on comparative analysis of original and generic fluconazole drugs are presented. The algorithm of rational choice of a drug on an example of fluconazole is formulated, property of a drug to suppress selectively activity of fungi of genus Candida, not showing hepatotoxic drugs, and also questions of correlation between reference and generic drugs on the basis of fluconazole is considered. The Federal Law “On Amendments to the Federal Law “On Circulation of Medicines“ No. 429-FZ (adopted on December 22, 2014 and entered into force on July 1, 2015) regarding the establishment of the procedure for determining the interchangeability of drugs, states: “Information on the interchangeability of drugs shall be included in the State Register of Medicines from January 1, 2018“. The law discloses the notion of interchangeable drugs, which “means a drug with proven therapeutic equivalence or bioequivalence regarding reference drugs, having equivalent qualitative formula and quantitative composition of active substances, formula and method of administration“. However, some definitions used so far in the law have been changed. Thus, instead of the term “original medicine“ the term “reference drug“ is used from July 1, 2015, which is defined as a medicine first registered in the Russian Federation, the quality, efficacy and safety of which has been proved based on the results of preclinical and clinical studies, and which is used to assess the bioequivalence or therapeutic equivalence, quality, efficacy and safety of generic or bioanalogue medicine. However, this article still uses the terms “original“ and “generic“ drugs, which are familiar to our medical community.

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

scholarly journals Generalized data of criteria of risk factors for the use of the drug torasemide from the materials of its preclinical studies

2020 ◽  
Author(s):  
Natalia A. Anisimova ◽  
Natalia O. Selizarova ◽  
Grigory A. Plisko ◽  
Evgeny D. Semivelichenko ◽  
Svetlana M. Napalkova
Keyword(s):  
Risk Factors ◽  
Arterial Hypertension ◽  
Clinical Studies ◽  
Generic Drugs ◽  
Preclinical Studies ◽  
Efficacy And Safety ◽  
Cardiovascular Pathology ◽  
Pharmacological Studies ◽  
Search For Information ◽  
Preclinical And Clinical Studies

This study presents the review and analysis of materials, the summary of the data on the results of experimental (preclinical) pharmacological studies of the drug Torasemide and the results of clinical studies of the original drug Demadex, based on risk factors influencing the outcomes of hypertension in people. The information on the efficacy and safety of the drugs based on Torasemide is also presented in the relevant sections of the article. The search for information sources for the review was carried out using domestic and international databases elibrary and PubMed, applying contextual queries, including international non-proprietary names, terms of preclinical studies of pharmacokinetics, pharmacodynamics, and animal species used. This review considers the aspects of safety, pharmacokinetics, primary and secondary pharmacodynamics of Torasemide, available in various sources describing its preclinical studies. The summarized data presented in the study, in our opinion, may be used by researchers who are engaged in preclinical and clinical studies, as well as the issues of studying the efficacy and safety of generic drugs used in the treatment of patients with arterial hypertension and other cardiovascular pathology. The information on the advantages of Torasemide in comparison with Furosemide in the treatment of animals with simulated arterial hypertension deserves special consideration.

Generic drugs: benefit/risk ratio

2021 ◽  
Vol 13 (6) ◽  
pp. 98-104
Author(s):  
E. A. Ushkalova ◽  
S. K. Zyryanov ◽  
I. A. Gopienko
Keyword(s):  
Clinical Practice ◽  
Active Ingredient ◽  
Comparative Studies ◽  
Generic Drugs ◽  
Comparable Efficacy ◽  
Synthesis Methods ◽  
Therapeutic Equivalence ◽  
Efficacy And Safety ◽  
Attending Physician ◽  
The Impact

The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice. Results of pharmacoepidemiological studies, which have been widely carried out recently, speak of insufficient understanding of the impact of generics on remote outcomes of chronic diseases, including mortality. The longterm economic prospects of generic drug administration continue to remain unclear. Among the primary differences between generics and brandname drugs are the differences in active ingredient synthesis methods and the composition of adjuvants and additives. Comparative studies on the therapeutic equivalence of generics with their originals or between themselves are rarely conducted. They are often affected by methodological flaws, which cannot ensure their comparable efficacy and safety. In this regard, automatic replacement of drugs containing the same active ingredient should be avoided without the participation of the attending physician.

Some aspects of pharmacological support with antidysrhythmic drugs

2021 ◽  
Vol 27 (2) ◽  
pp. 145-152
Author(s):  
Vladimir V. Archipov ◽  
Yuliya R. Bolsunovskaya
Keyword(s):  
Cardiovascular Diseases ◽  
Generic Drugs ◽  
Analytical Data ◽  
Open Data ◽  
The State ◽  
Federal Law ◽  
Social Significance ◽  
Conduction Disorders ◽  
State Register ◽  
High Level

A high level of morbidity and mortality from cardiovascular diseases remains prevalent in the Russian Federation, despite a decreasing trend that emerged in recent years. Rhythm and conduction disorders play an essential role in the thanatogenesis of cardiovascular pathology, which determines the medical and social significance of their pharmacotherapy. This is indicated by the stable demand for antidysrhythmic drugs from both the state and the population. This is evidenced by high levels of public procurements and retail sales of drugs for the treatment of cardiovascular diseases, since patients take this drug group for a long time and often permanently. Our marketing analysis of the antidysrhythmic drugs market used current open data from the State Register of Medicines and the State Register of Maximum Selling Prices and available analytical data. It showed that from 54.5% (metoprolol drugs) to 100% (procainamide drugs) of the market share is occupied by generic drugs made in Russia. The presented analysis confirms the assumption of a significant increase in the share of generic drugs in public procurements. This is associated with the implementation of the drug safety program for vital and essential drugs and the optimization of costs by the state. A priority of the state drug policy in Russia is to monitor the effectiveness and safety throughout its entire life cycle. Moreover, particular importance should be given to the issue of interchangeability, which is regulated by Federal Law No. 1360 dated September 5, 2020, On the Procedure for Determining the Interchangeability of Medicines for Medical Use. The annual increase in the share of generic domestic antidysrhythmic drugs on the market poses the problem of selecting the most efficient and safe approach to pharmacotherapy for practicing specialists. The solution may be to develop and implement open automated information systems for the safety profiles of the original and generic antidysrhythmic drugs.

Human Rights Activities as a Function of the Prosecutor’s Office

2020 ◽  
Vol 3 ◽  
pp. 88-93
Author(s):  
K.N. Golikov ◽  
Keyword(s):  
Human Rights ◽  
Civil Rights ◽  
Russian Federation ◽  
The State ◽  
Main Function ◽  
Federal Law ◽  
The Subject ◽  
The Russian Federation ◽  
The Law

The subject of this article is the problems of the nature, essence and purpose of prosecutorial activity. The purpose of the article is to study and justify the role of the human rights function in prosecutorial activities in the concept of a modern legal state. At the heart of prosecutorial activity is the implementation of the main function of the Prosecutor’s office – its rights and freedoms, their protection. This means that any type (branch) of Prosecutor's supervision is permeated with human rights content in relation to a citizen, society, or the state. This is confirmed by the fact that the Federal law “On the Prosecutor's office of the Russian Federation” establishes an independent type of Prosecutor's supervision-supervision over the observance of human and civil rights and freedoms. It is argued that the legislation enshrines the human rights activities of the Prosecutor's office as its most important function. It is proposed to add this to the Law “On the Prosecutor's office of the Russian Federation”.

GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE

JAMA ◽  
1968 ◽  
Vol 206 (8) ◽  
pp. 1785 ◽  
Author(s):  
Dale G. Friend
Keyword(s):  
Generic Drugs ◽  
Therapeutic Equivalence

Bronchodilator and anti-inflammatory therapy of chronic obstructive pulmonary disease from the position of interchangeability

2021 ◽  
Vol 31 (4) ◽  
pp. 518-529
Author(s):  
E. A. Orlova ◽  
I. P. Dorfman ◽  
M. A. Orlov ◽  
A. K. Andreeva ◽  
M. A. Abdullaev
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Generic Drugs ◽  
The State ◽  
Chronic Obstructive ◽  
Anticholinergic Drugs ◽  
Adherence To Treatment ◽  
Obstructive Pulmonary Disease ◽  
State Register ◽  
Anti Inflammatory

The choice of drugs used to treat patients with chronic obstructive pulmonary disease (COPD) (inhaled β-agonists, M-anticholinergic drugs, inhaled corticosteroids (ICS)) in view of their interchangeability is reviewed in this article. This aspect is especially important for clinicians when choosing an effective and safe treatment for COPD and for increasing patient adherence to treatment.The aim of this study was to assess the ratio of the number of reference (original), interchangeable, and generic drugs used in COPD.Methods. In accordance with the Russian clinical guidelines 2018 and GOLD 2019, modern drugs for the treatment of COPD with bronchodilator and anti-inflammatory activity were selected. All trade names of the corresponding drugs for each international non-proprietary name (INN) In the State Register of Medicines website were considered. The information on the availability of reference (original) drugs and the corresponding interchangeable products, as well as their presence in the List of vital and essential drugs was analyzed.Results. A large number of generic prodcuts are registered in the State Register of Medicines, and only a few of them are interchangeable with the corresponding reference (original) drug.Conclusion. The analysis will help widen the doctors’ choice of interchangeable drugs in treatment of COPD with an equivalent effect and safety of reference drugs, as well as to increase the patients’ adherence to treatment.

scholarly journals Involvement in the organized market of such forms of self employment in rural areas as personal subsidiary farms of citizens

2021 ◽  
Vol 0 (13) ◽  
pp. 31-37
Author(s):  
Ekaterina Kot ◽  
Tat'yana Zyryanova ◽  
Sergey Zyryanov
Keyword(s):  
Rural Areas ◽  
Financial Literacy ◽  
Theoretical Research ◽  
Practical Significance ◽  
Federal Law ◽  
Strategic Development ◽  
Axiomatic Analysis ◽  
Self Employment ◽  
Deductive Method ◽  
The Law

Abstract. Within the framework of a set of measures for the implementation of the national project on small and medium-sized enterprises and support for individual entrepreneurial initiative in accordance with the Decree of the President of the Russian Federation on national goals and strategic development tasks, the importance of involving citizens in independent production activities is reflected. In this regard, Federal Law No. 422-FL of 27 November 2018 (hereinafter referred to as the Law) initiated a tax experiment to establish a new special tax regime “Tax on Professional Income” (hereinafter referred to as the TPI). The purpose of the study is to determine the economic impact of the new tool on the involvement in economic turnover of such a form of self-employment in rural areas as personal subsidiary farms of citizens. Tasks: 1) using the deductive method of theoretical research to analyze the effect of the experiment on the application of the new special tax regime on the territory of Russia; 2) to consider in practical situations the options for applying the TPI for self-employed citizens; 3) systematize data on the calculation of naps in the form of a model that has theoretical and practical significance for the involvement of private subsidiary farms (hereinafter referred to as PSF) in an organized market. Research methods: deduction, axiomatic, analysis, synthesis, comparison, experiment, measurement. The scientific novelty and results is that according to the Law, a new target group is allocated – self-employed citizens who indicate services in different fields of activity. In agriculture, it is also necessary to direct the activities of PSF that sell their own products to an organized market. Results. In order to help improve financial literacy with the support of self-employed entrepreneurs, a comparative analysis of deductions for the calculation of professional income tax was conducted. Algorithms for calculating naps have been developed, which are the basis for considering practical situations. A model has been compiled that systematizes the procedure for applying the TPI for self-employed citizens.

scholarly journals The Interior Appeal of the FAS of Russia: the Role of Legal Positions in the Development of Uniformity of Law Enforcement Practice

2019 ◽  
pp. 78-83
Author(s):  
O. A. Moskvitin ◽  
I. P. Bochinin
Keyword(s):  
Law Enforcement ◽  
Competition Law ◽  
Federal Law ◽  
Antimonopoly Law ◽  
Uniform Law ◽  
The Law ◽  
Compliance With The Law ◽  
The Right

The article discusses some problems of the formation of a uniform law enforcement practice on the example of specific decisions of the FAS Russia Board of Appeals on issues related to: the application of the rules for the qualification of antitrust violations provided for in part 1 of art. 10 of the Federal Law «On Protection of Competition»; the need to prove the fulfillment of an agreement prohibited by art.16 of the same Law; the exercise of the right of the FAS Russia collegial bodies to refer the matter for a new consideration to the territorial antimonopoly body. It is concluded that the legal positions of the Appeal Board of FAS Russia, being based on the law and applied only in compliance with the law, help to effectively resolve controversial problems of pre-trial Antimonopoly law enforcement and to develop uniform approaches to the interpretation of the rules of competition law.

scholarly journals Lixarit — clinical and pharmaceutical aspects of efficacy and safety of flecainide acetate generic drug

HYPERTENSION ◽  
2021 ◽  
Vol 14 (4) ◽  
pp. 21-25
Author(s):  
N.V. Bezditko
Keyword(s):  
Health Care ◽  
Generic Drug ◽  
Antiarrhythmic Agent ◽  
Efficacy And Safety ◽  
Reference Drug ◽  
Flecainide Acetate

The article considers the use of flecainide, an antiarrhythmic agent. The results of comparing the bioequivalence of Lixarit, flecainide acetate generic drug (flecainide acetate, 100 mg tablets, Laboratorios Normon SA, Spain), and Apocard®, flecainide acetate reference drug (Health Care Ltd, UK, 100 mg tablets), are presented.

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