An Assessment of the Quality of Pharmaceutical Companies in China and India related to FDA Inspections

2020 ◽  
Author(s):  
Stephanie Behrakis
Keyword(s):  
Pharmaceutical Companies ◽  
China And India

scholarly journals Evidence based medicine? Access to information & medicines regulation in New Zealand

2021 ◽  
Author(s):  
◽  
Amy Hill
Keyword(s):  
New Zealand ◽  
Regulatory Regime ◽  
Pharmaceutical Companies ◽  
Evidence Based ◽  
Access To Information ◽  
The Public ◽  
The World ◽  
Medicines Regulation ◽  
Based Medicine

<p>This paper explores one very important issue in the regulatory regime for medicines in New Zealand and around the world- the deficit of information about medicines available to doctors, patients and independent researchers. Much of the information about safety, efficacy and quality of drugs is held and controlled by pharmaceutical companies and regulators. The public is entitled to this information in full.</p>

scholarly journals Basic research in the context of the development of medical substances and technologies

2018 ◽  
pp. 84-86
Author(s):  
Л.В. Кузнецова ◽  
Л.Ю. Бахтина ◽  
И.Ю. Малышев
Keyword(s):  
Experimental Design ◽  
Technology Development ◽  
Scientific Research ◽  
Basic Research ◽  
Pharmaceutical Companies ◽  
High Quality ◽  
Pharmacological Research ◽  
Design And Methods

В кратком обзоре обсуждаются задачи фармацевтических компаний, и вопросы о наиболее рациональном соотношении скорости, стоимости и качества процесса разработки лекарств и технологий (DDD). Делается заключение, что экспериментальный дизайн и методы медико-фармакологических исследований должны разрабатываться на основании современных принципов и представлений о содержании этапов DDD, с особым акцентом на высокое качество научных исследований на этапе открытия. This brief review discusses challenges of pharmaceutical companies and issues of the most rational relationship between the speed, cost, and quality of the process for drug and technology development (DTD). It was concluded that the experimental design and methods of medical and pharmacological research should be developed on the basis of modern principles and ideas about the essence of DTD stages with a particular emphasis on the high quality of scientific research at the stage of discovery.

scholarly journals Market Survey and Analysis of Packaging Information Provided by Different Pharmaceutical Companies of Bangladesh

2012 ◽  
Vol 15 (2) ◽  
pp. 165-169
Author(s):  
Shibtosh Sarker ◽  
Arindom Pal ◽  
Jesmin Sultana
Keyword(s):  
Pharmaceutical Journal ◽  
Pharmaceutical Products ◽  
Packaging Material ◽  
Pharmaceutical Companies ◽  
Packaging Materials ◽  
Clinical Parameters ◽  
Dhaka City ◽  
Market Survey

The purpose of the present study was to investigate whether or not the pharmaceutical companies of Bangladesh are providing all the necessary information and instructions in the packaging materials of pharmaceutical products which are available in Bangladesh. With this aim, the sample of secondary packaging material (cartons, labels, inserts or direction slips) of a total 150 products (from 50 generics) marketed by 15 pharmaceutical companies have been selected and were collected from different medical stores of Dhaka city. The packaging materials of the collected samples were then evaluated based on various regulatory and clinical parameters. It was found that some of the packaging materials of these selected pharmaceutical products lack several  important information in terms of clinical and regulatory parameters which limits the quality of these packaging materials. DOI: http://dx.doi.org/10.3329/bpj.v15i2.12585 Bangladesh Pharmaceutical Journal 15(2): 165-169, 2012

scholarly journals Cleaner Production Quality Regulation Strategy of Pharmaceutical with Collusive Behavior and Patient Feedback

Complexity ◽  
2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Junmei Rong ◽  
Lilong Zhu
Keyword(s):  
Medical Service ◽  
Evolutionary Game ◽  
Cleaner Production ◽  
Pharmaceutical Companies ◽  
Drug Quality ◽  
Quality Regulation ◽  
Patient Feedback ◽  
Strict Regulation ◽  
Service Agencies

The quality of pharmaceuticals has always been a hot issue in the world, and it involves public health, economic development of countries, social stability, and national security. Cleaner production is a prerequisite for ensuring the quality of medicines. However, the various types of counterfeit pharmaceuticals and fake vaccines exposed in the recent years have revealed many problems, such as lacking government regulation, loose quality management of companies, illegal profit of medical service agencies, and failure of patient complaints. This paper’s two innovations are as follows: first, it not only considers the collusion between pharmaceutical companies and medical service agencies, but also introduces patient feedback to study drug quality regulation strategies from a microperspective; second, this paper constructs a tripartite evolutionary game model involving cleaner production pharmaceutical companies, medical service agencies, and the governments to analyze the evolutionary stability using the Lyapunov first rule. The results of the research show that, first, improvement of patient complaint rates can effectively curb collusive behavior and promote the stable improvement of cleaner production drug quality; second, the governments must impose sufficient fines on pharmaceutical companies to avoid a stable strategic combination of collusion; third, enhancing patient feedback can speed up the evolution of the stable choice of legitimate strategies by pharmaceutical companies and the medical service agencies; finally, the government reducing the strict regulation costs can increase the strict regulation rate employed in the evolution process and slow down the pace of evolution to loose regulation. In addition, the simulation analysis was carried out using Matlab 2017b, which verified the validity of the model and proved the practical meaning of countermeasures and suggestions for improving government quality regulation.

Japanese interpretations of “pain” and the use of psychomimes

2014 ◽  
Vol 1 (2) ◽  
pp. 216-238 ◽  
Author(s):  
Yuko Asano-Cavanagh
Keyword(s):  
The Body ◽  
Pharmaceutical Companies ◽  
Metaphorical Meaning ◽  
Naturally Occurring ◽  
Japanese English

This paper examines six Japanese psychomimes — zuki-zuki, kiri-kiri, shiku-shiku, chiku-chiku, hiri-hiri, and gan-gan — that express subtle differences in states or sensations regarding “pain”. It is generally recognized, however, that many languages lack words with the same meanings as these Japanese psychomimes and that their meanings are difficult to capture precisely. The definitions in Japanese-English dictionaries, for example, are not sufficient to explain the exact meanings and there is also the problem that each Japanese expression can correspond to several English verbs. This study applies the framework of the Natural Semantic Metalanguage approach to explicate the meaning of the six Japanese psychomimes. It makes reference to a corpus of naturally-occurring examples compiled from publicly available sources from physicians, patients, hospitals, and pharmaceutical companies. The analysis indicates that each psychomime conveys a vivid metaphorical meaning. The quality of the pain is suggested by reference to an imagined scenario of something moving inside a part of the body or touching part of the body. This imagined ‘something’ can be understood as something ‘sharp’ or as something similar to ‘fire’ or to ‘metal’. The use of psychomimes is an effective and efficient way for expressing and understanding “pain” in Japanese.

Implementation of effective, self-sustaining headache services in the Republic of Georgia: Evaluation of their impact on headache-related disability and quality of life of people with headache

Cephalalgia ◽  
2017 ◽  
Vol 38 (4) ◽  
pp. 639-645 ◽  
Author(s):  
Gvantsa Giorgadze ◽  
Maka Mania ◽  
Maka Kukava ◽  
Ana Dzagnidze ◽  
Ekaterine Mirvelashvili ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Episodic Migraine ◽  
Primary Outcome Measure ◽  
Tension Type Headache ◽  
International Standards ◽  
Pharmaceutical Companies ◽  
The Republic ◽  
Type Headache

Background Headache disorders are widespread and disabling. They are common in Georgia, especially headache on ≥15 days/month (HA ≥ 15), but there are no headache services. Objective We established headache services meeting local needs, investigating feasibility, consumer uptake and satisfaction, and cost, with an exit strategy bequeathing effective, self-sustaining services that could be rolled out nationwide. Methods We created headache centres in Tbilisi and Gori offering free expert care for three visits over three months, and affordable medication thereafter. The primary outcome measure was the percentage of patients using the service beyond the free period – a measure of both satisfaction and sustainability. Results Of 1,445 patients (age 43.7 ± 12.4 years; 10.5% male), 49.8% had episodic migraine, 22.5% episodic tension-type headache, 25.7% HA ≥ 15 (24.5% overusing medication) and 2.0% trigeminal autonomic cephalalgias. Only 454 (31.4%) and 51 (3.5%) returned for second and third visits; in these, headache improved and treatment costs decreased. As information about the service spread, five other headache clinics opened in Tbilisi and Kutaisi (western Georgia). Pharmaceutical companies reduced prices (sumatriptan 100 mg from US$7 to US$1). Conclusion The study failed to achieve its primary outcome, but sustainable headache services operating to international standards were successfully implemented nonetheless, with demand increasing.

scholarly journals Investigating the Relationship between the Type of Auditors and Disclosure Domain Quality among Pharmaceutical Companies Listed in Tehran Stock Exchange

2017 ◽  
Vol 5 (1) ◽  
pp. 45
Author(s):  
Alireza Hirad ◽  
Mahmoodreza Rakhshani
Keyword(s):  
Research Method ◽  
Stock Exchange ◽  
Accurate Information ◽  
Pharmaceutical Companies ◽  
Audit Report ◽  
Audit Process ◽  
Draft Report ◽  
Statistical Population ◽  
The Relationship

This research examines the relationship between the type of auditor's report and disclosure domain quality of the pharmaceutical companies listed in the Tehran Stock Exchange. The research method is inductive and is categorized in applied research according to research purpose. Research method and data analysis method is done using multiple correlation coefficient models and multiple regression. The statistical population of this study was all pharmaceutical companies listed in Tehran Stock Exchange during the years 2010-2014, which 488 companies have been selected. In this research, CD-ROMs and statistical software of Tehran Stock Exchange and other software available in Tehran stock exchange have been used to collect data in the present research. To document the results, statistical analysis and presenting final solutions, the researcher analyzed the questions and hypothesis using a statistical method as well as 7 Eviews software. The results of the main hypothesis of research show that there is a significant relationship between the type of audit report and disclosure domain quality in pharmaceutical companies. Given that disclosure domain quality of accounting information, documentation and clarification by the client after the issuance of the draft report and the client's attempt to justify the auditor are effective factors in disclosure domain quality, since increased disclosure quality has improved the financial reporting as well as the quality of the auditors' opinion. Increasing the quality can provide the necessary background for ease of implementation of the audit process, reduce audit risks, and ultimately reduce the auditors 'pessimism to the investigative body, each of which can more accurately report auditors' reports more qualitatively. The results also show that Audit Report has a higher degree of desirability to the extent that managers cooperate with the auditors in providing relevant and quality information and provide realistic and accurate information without any distortion or fraud and will show audit reports more qualitatively.

scholarly journals Current aspects of risk management in clinical trials

2020 ◽  
pp. 45-52
Author(s):  
E. A. Polozova
Keyword(s):  
Clinical Trial ◽  
Risk Management ◽  
Clinical Trials ◽  
Cost Savings ◽  
Pharmaceutical Companies ◽  
Main Task ◽  
Legal Requirements ◽  
Financial Cost ◽  
The Cost

Improving the quality of drugs is the main task of the pharmaceutical industry as a whole. Getting safe and eff ective medications is directly related to minimizing the risks of conducting clinical trials. Maintaining the quality of clinical research based on risk management is a continuous, constant and dynamic process ensuring the success of the study, which in turn leads to the integrity of the data collected, the safety of subjects and compliance with legal requirements, as well as to the financial cost savings of pharmaceutical companies. The cost of research is growing inexorably, and the quality of their research is rapidly declining, so it is important to use a risk-based approach when developing the upcoming clinical trial project.

scholarly journals Ultrasound for Drug Synthesis: A Green Approach

2020 ◽  
Vol 13 (2) ◽  
pp. 23 ◽  
Author(s):  
Micheline Draye ◽  
Gregory Chatel ◽  
Romain Duwald
Keyword(s):  
Quality Of Life ◽  
Energy Efficient ◽  
Bioactive Molecules ◽  
Pharmaceutical Companies ◽  
Drug Candidates ◽  
Environmental Consequences ◽  
Green Approach ◽  
Drug Synthesis ◽  
Energy Consuming

This last century, the development of new medicinal molecules represents a real breakthrough in terms of humans and animal life expectancy and quality of life. However, this success is tainted by negative environmental consequences. Indeed, the synthesis of drug candidates requires the use of many chemicals, solvents, and processes that are very hazardous, toxic, energy consuming, expensive, and generates a large amount of waste. Many large pharmaceutical companies have thus moved to using green chemistry practices for drug discovery, development, and manufacturing. One of them is the use of energy-efficient activation techniques, such as ultrasound. This review summarizes the latest most representative works published on the use of ultrasound for sustainable bioactive molecules synthesis.

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