A Novel Comparative Evaluation for the Quality of Oral Generic Drugs

Background: The concept of evaluating bioequivalence has changed over a period of time. Currently, the Average Bioequivalence approach (ABE) is the gold standard tool for the evaluation of generics. Of late, many debates had arisen about employing ABE approach for the appraisal of all drug categories. This review aims to examine the limitations of ABE approach and the significances of Population Bioequivalence (PBE) and Individual Bioequivalence (IBE) approach, current regulatory thinking for assessing different categories of the drug, whether they are adequately assessed, and the evaluation is in the right direction. Methods: We carried out an organized search of bibliographic databases for peer-reviewed research literatures, regulatory recommendations, guidance documents using a focused review question and eligibility criteria. The standard tools were used to appraise the quality of retrieved documents and to make sure the authenticity of the data. Results: In total 73 references were used in the review, the majority of the references (guidance documents) were from the different regulatory agencies and product-specific guidance. There were 29 product-specific guidance from USFDA and EMA. The limitations of the ABE approach were discussed in detail along with the significances of Population Bioequivalence (PBE) approach and Individual Bioequivalence (IBE) approaches. Conclusion: It is apparent from the review that IBE approach is a precise method for evaluating the drugs as it answers drug interchangeability (prescribability and switchability). IBE approach is followed by PBE approach and ABE approach for the evaluation of different categories of drugs in terms of precision.

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Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x07666200808163247 ◽

2020 ◽

Vol 07 ◽

Author(s):

Paramjeet Malik ◽

Neelam Pawar ◽

Kavita Bahmani

Keyword(s):

Generic Drugs ◽

Drug Product ◽

Drug Approval ◽

Approval Process ◽

Regulatory Requirements ◽

Team Members ◽

Regulatory Authorities ◽

Effective Manner ◽

Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

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Pharmacoeconomic features of the use of drugs used in the treatment of allergic rhinitis

"Medical & pharmaceutical journal "Pulse" ◽

10.26787/nydha-2686-6838-2021-23-2-9-16 ◽

2021 ◽

pp. 9-16

Author(s):

Afanasyeva T.G. ◽

Lavrova N.N. ◽

Tumentseva V.R.

Keyword(s):

Quality Of Life ◽

Allergic Rhinitis ◽

Nasal Mucosa ◽

Generic Drugs ◽

Cost Minimization ◽

Nasal Congestion ◽

World Health ◽

Cost Minimization Analysis ◽

Wide Range

Rhinitis is an inflammation of the nasal mucosa; today, according to the World Health Organization, the prevalence of the disease is 40% of the world's population. Allergic rhinitis is the most common type of chronic rhinitis, affecting 10–20% of the world's population, and the severity of the disease is associated with a significant deterioration in the quality of life, sleep and performance. Allergic rhinitis is an inflammatory disease of the nasal mucosa caused by exposure to an allergen, causing IgE-mediated inflammation. Clinically, the disease is characterized by the following main symptoms: rhinorrhea, sneezing, itching and nasal congestion. Despite the general symptoms of allergic rhinitis, its impact on the quality of life of patients and the significant cost of treatment, including pharmacotherapy, many patients do not adhere to drug treatment regimens due to their insufficient effectiveness in eliminating the emerging symptoms. Pharmacoeconomic research identifies, measures and compares the costs and effects of drug use. This framework includes research methods related to cost minimization, cost-effectiveness, decision analysis, cost of illness, and patient quality of life. This article will consider one of the four main methods for assessing pharmacoeconomics - cost minimization analysis. A cost-minimization analysis is a pharmacoeconomic assessment by comparing the costs of two or more drug alternatives regardless of outcome. Since the pharmaceutical market is represented by a wide range of original, reference and generic drugs for the treatment of allergic rhinitis, an important aspect of our research is the selection of effective and economically acceptable therapy for outpatients.

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A methodological exploration of social quality research: A comparative evaluation of the quality of life and social quality approaches

International Sociology ◽

10.1177/0268580913484776 ◽

2013 ◽

Vol 28 (3) ◽

pp. 316-334 ◽

Cited By ~ 5

Author(s):

Ka Lin

Keyword(s):

Quality Of Life ◽

Comparative Evaluation ◽

Quality Research ◽

Social Quality

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Features of parasitocenosis in eimeriosis in young ruminants

Agrarian Bulletin of the ◽

10.32417/1997-4868-2021-14-91-100 ◽

2021 ◽

Vol 0 (14) ◽

pp. 91-100

Author(s):

Vera Usevich ◽

N. Kurochkina ◽

M. Drozd ◽

Ol'ga Petrova

Keyword(s):

Comparative Evaluation ◽

Animal Species ◽

Treatment Time ◽

Global Scale ◽

Laboratory Diagnostics ◽

Therapeutic Effectiveness ◽

Treatment And Prevention ◽

Traditional Remedies ◽

Eimeria Arloingi

Abstract. The prevalence of coccidiosis diseases of various animal species has a global scale, so this problem has attracted the attention of veterinary specialists around the world. The purpose of this study was to study the specific features of the species composition and laboratory diagnostics of eimeriosis in young ruminants and to evaluate the effectiveness of treatment and prevention when using drugs from different groups. The material for the study was goats and calves. The research was carried out on the basis of two farms of the same agricultural holding in the Sverdlovsk region. Diagnostics was performed based on clinical and laboratory studies. Results of the study. The main pathogens in the goat breeding complex in goats of different ages were identified: the main causative agent of coccidiosis in 120-day-old goats was Eimeria arloingi, which accounted for 54 % of all detected oocysts in the samples. Eimeriosis occurred as a mixed invasion of Eimeria arloingi with Eimeria ninaekohlyakimovae (33 %) and Eimeria intracata (13 %). Eimeria arloingi (68 %), in 21-days-old goats – Eimeria ninaekohlyakimovae (32 %). Eimeriosis caused by Eimeria bovis was detected in 30-days-old calves (100 %). The article describes the results of using various anticoccidial drugs in the treatment and prevention of eimeriosis. A comparative evaluation of the therapeutic effectiveness of known coccidiostatics is given. The economic efficiency of different groups of drugs was evaluated. The scientific novelty lies in the fact that the morphological and quantitative assessment of parasitocenoses in eimeriosis in young ruminants was carried out. A comparative evaluation of the effectiveness of various traditional remedies and a new drug for the treatment of eimeriosis in calves and goats was carried out. Conclusion. Not all of the drugs used have the same therapeutic effectiveness both in terms of treatment time and the quality of elimination of the etiological factor.

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Evaluation of rational prescribing and dispensing of medicines in Mali

Revue Malienne d'Infectiologie et de Microbiologie ◽

10.53597/remim.v0i9.929 ◽

2017 ◽

Author(s):

Yaya Coulibaly ◽

Fanta Sangho ◽

Aboubacar Alassane Oumar

Keyword(s):

Public Sector ◽

Private Sector ◽

Treatment Guidelines ◽

Generic Drugs ◽

Cross Sectional Study ◽

Cross Sectional ◽

Medical Practitioners ◽

The Public ◽

Quality Of Prescribing

Objective: The drug policy of Mali is based on the concept of essential generic drugs. The adoption of generic drugs in a program is often accompanied by irrational use of these drugs precisely because of the availability of these drugs. Thus, this study was initiated to assess the quality of prescribing and dispensing drugs in Mali. Methods: This is a descriptive cross-sectional study was conducted from 2004 to 2013, the survey was conducted in 20 primary health centers and 20 private pharmacies in three regions of the country. In each of these structures, 30 prescriptions filled at the time of the survey were collected. Results: The average number of drugs per prescription was 3.0 ± 1.3 and 2.4 ± 1.2, respectively, in the public and private sectors. Prescription of drugs under international name was 91.6% in the public sector and 37.2% in the private sector. The public sector prescribed 33.7% of injectable drug against 16.2% in the private sector (p <0.001). The average cost of a prescription was lower in the public sector (3415.3 FCFA or 5.21euros) than in the private sector (7111 FCFA or 10.85 euros).Conclusion: Generic drugs are commonly used in the public, but much less in the private sector. The treatment guidelines are already available, should be introduced interactively to medical practitioners, through visits and intensive supervision by more experienced managers in the hierarchy, it would be likely to improve the quality of prescribing practitioners.

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Near infrared (NIR)-spectroscopy and in-vitro dissolution absorption system 2 (IDAS2) can help detect changes in the quality of generic drugs

Drug Development and Industrial Pharmacy ◽

10.1080/03639045.2019.1701004 ◽

2020 ◽

Vol 46 (1) ◽

pp. 80-90

Author(s):

Carlos Jiménez-Romero ◽

Johayra Simithy ◽

Anthony Severdia ◽

Daniel Álvarez ◽

Manuel Grosso ◽

...

Keyword(s):

Near Infrared ◽

Generic Drugs ◽

Nir Spectroscopy ◽

In Vitro Dissolution ◽

Absorption System ◽

System 2

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Business and Technology Issues in Wireless Networking

Encyclopedia of Mobile Computing and Commerce ◽

10.4018/978-1-59904-002-8.ch016 ◽

2007 ◽

pp. 90-95

Author(s):

D. Wright

Keyword(s):

Quality Of Service ◽

Mobile Computing ◽

Comparative Evaluation ◽

Range Data ◽

Metropolitan Area Networks ◽

Ground Speed ◽

Market Growth ◽

Major Development ◽

Communications Standards

A major development in the enabling technologies for mobile computing and commerce is the evolution of wireless communications standards from the IEEE 802 series on local and metropolitan area networks. The rapid market growth and successful applications of 802.11, WiFi, is likely to be followed by similar commercial profitability of the emerging standards, 802.16e, WiMAX, and 802.20, WiMobile, both for network operators and users. This article describes the capabilities of these three standards and provides a comparative evaluation of features that impact their applicability to mobile computing and commerce. In particular, comparisons include the range, data rate in Mbps and ground speed in Km/h plus the availability of quality of service for voice and multimedia applications.

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