The basis of the discovery process for a new pharmaceutical product

Open Medicine ◽  
2012 ◽  
Vol 7 (6) ◽  
pp. 691-699
Author(s):  
Veselin Dickov
Keyword(s):  
Pharmaceutical Industry ◽  
Mechanism Of Action ◽  
Active Ingredient ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Discovery Process ◽  
Innovative Drug ◽  
Consumer Value ◽  
History Of ◽  
The Cost

AbstractThe basis of the discovery process for a new pharmaceutical product is in understanding the mechanism of action of a particular disease or processes in the organism related to the disease and/or its symptoms. The essence of a pharmaceutical is in the active ingredient capable of affecting processes within the organism beneficially. The discovery process includes a particular sequence of activities of various profiles of experts, about which various authors agree. The history of pharmaceutical industry (and pharmacy) is measured from one discovery of an innovative drug or approach to treatment of a particular disease to the next one. The cost of pharmaceutical products is one of the key causes of controversy related to this industry. Numerous cultures have proverbs expressing the opinion that health is priceless or that health is the greatest wealth. What if health does have a price? One of the basic premises of marketing is that price should reflect consumer value.

New pharmaceutical product development: Barriers to overcome and opportunities to exploit

2008 ◽  
Vol 14 (3) ◽  
Author(s):  
Nic S Terblanche
Keyword(s):  
Pharmaceutical Industry ◽  
Biotechnology Industry ◽  
Pharmaceutical Product ◽  
New Drugs ◽  
New Approach ◽  
Pharmaceutical Product Development ◽  
Sales And Marketing ◽  
Rate Of Increase ◽  
State Of Affairs ◽  
The Cost

The pharmaceutical industry experienced an unprecedented rate of increase in the cost of developing new drugs while the number of new drugs that were approved and accepted in the marketplace has reached a very low level. Various factors are responsible for this state of affairs. One of the major opportunities available to the pharmaceutical industry to improve this situation is to collaborate with the biotechnology industry. The future solutions to a host of current diseases as well new strains of existing ones lie in the cooperation between these two industries. The pharmaceutical industry will, however, have to carefully manage challenges such as increased governmental control and the damaged image of the industry. There are many opportunities offered by offshoring, advanced application of information technology, climate change and a new approach to sales and marketing, all of which the pharmaceutical industry can exploit. Should the pharmaceutical industry manage to address the issues responsible for the high costs prevalent in the industry, its role as partner with the biotechnology industry could prove to be very beneficial for both these industries.

Problems Facing the Arab Pharmaceutical Industry: A Case Study from Yemen

2016 ◽  
Vol 2 (4) ◽  
pp. 234-241
Author(s):  
Mohammed Al-Shakka ◽  
Ebtesam Abood ◽  
Adel Al-Dhubhany ◽  
Sami Abdo Radman Aldubai ◽  
Khaled Said ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Low Income ◽  
Well Being ◽  
Pharmaceutical Products ◽  
Domestic Market ◽  
Raw Material ◽  
Political Crisis ◽  
Pharmaceutical Manufacturer ◽  
University Graduates ◽  
Pharmaceutical Drugs

Because of the almost-instant connection with the welfare and well-being of individuals, pharmaceutical industry stands prominently as a very important factor for the improvement and progress of a healthy productive nation. These days, pharmaceutical industry thrives as one of the largest and exponentially expanding global industries. Nonetheless, millions of people in low income developing countries, have to suffer from the fatal consequences of the inaccessibility and non-availability of essential drugs. This is also happening in Yemen, where the pharmaceutical manufacturers sector have to face up to many challenges. The Yemen Drug Company (YEDCO) was founded in 1964 by the Yemeni government as it collaborated with private investors. It was endorsed as a company with the expertise in the medicinal drug marketing. YEDCO started its work by taking in drugs from foreign companies and then locally marketing and distributing them. In 1982, YEDCO built the first medicinal factory for drugs in Sana’a. Since then, seven companies were set up to manufacture medicines in Yemen. The expanding population has led to the need to have more pharmaceutical products. It may be understandable that pharmaceutical manufacturer companies are also hit by the political crisis in the country. Inadequate amount of fuel and raw material as well as low security status were some of the underlying factors behind these ill-effects in Yemen. Imported drugs make up about nearly 90% % of the pharmaceutical market compared to 10% drugs from the domestic market. This situation has led to an additional burden being shouldered by the national economy, where Yemen spends about US$263 million annually on pharmaceutical drugs, in reference to the national Supreme Drugs Authority. Although there is a very quick growth in the population and drugs consumption, the pharmaceutical industry has not been very active, where global pharmaceutical products play their role dominantly on the domestic market. The pharmaceutical production necessitates skilled human resources like university graduates. By contrast, the government and the private sector should also motivate the pharmaceutical industry and make use of the local employment

Actual issues of hygienic regulation and creation of safe working conditions at pharmaceutical manufacturing enterprises

2020 ◽  
Vol 60 (10) ◽  
pp. 640-644
Author(s):  
Vadim M. Vasilkevich ◽  
Ruslan V. Bogdanov ◽  
Elena V. Drozdova
Keyword(s):  
Pharmaceutical Industry ◽  
Working Conditions ◽  
Experimental Studies ◽  
Pharmaceutical Products ◽  
Laboratory Animals ◽  
Production Environment ◽  
Basic Principles ◽  
Toxicological Studies ◽  
Health Disorders ◽  
Safe Working

Introduction. The working conditions of pharmaceutical industry workers are characterized by the combined effect of unfavorable factors of the production environment, among which the leading one is chemical. The aim of study is to substantiate the basic principles and criteria for hygienic regulation of pharmaceutical products in their production to ensure safe working conditions for employees based on the results of their own research and existing requirements of technical regulations. Materials and methods. Analysis of working conditions and the prevalence of health disorders in pharmaceutical workers (according to literature data), toxicological studies of pharmaceutical substances on laboratory animals, scientific justification of hygiene standards in the air of the working area. Results. Among employees of the pharmaceutical industry, the predominant forms of production-related health disorders are diseases of the respiratory system, as well as skin dermatitis of allergic origin, liver and biliary tract diseases. Based on the results of experimental studies of domestic pharmaceutical products for the treatment of cardiovascular, oncological and mental diseases that have priority socio-economic significance, the basic principles and features of the practice of justifying the hygienic standards of medicines in the air of the working area are developed and systematized. Conclusions. During hygienic rationing of medicines, it is necessary to use a differentiated approach that allows, based on the analysis of information about the chemical structure, physical and chemical characteristics, production conditions, pharmacotherapeutic activity, and the results of studying the toxic effect in an experiment on laboratory animals, to determine the maximum permissible content in the air of the working area of medicines or to justify the prohibition of isolation with reasoned recommendations for their safe production.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

This Is an Abridged Account of Delhi Which Is an Old City and One of the Chosen Ones amongst the Cities

2018 ◽  
Author(s):  
Mirza Sangin Beg
Keyword(s):  
Popular Culture ◽  
East India Company ◽  
Ordinary People ◽  
Work Spaces ◽  
History Of ◽  
English East India Company ◽  
Local Traditions ◽  
The Cost ◽  
The City ◽  
Cost Of Construction

The second part of the translation has three segments. The first is dedicated to the history of Delhi from the time of the Mahabharat to the periods of Anangpal Tomar to the Mughal Emperor Humayun as also Sher Shah, the Afghan ruler. In the second and third segments Mirza Sangin Beg adroitly navigates between twin centres of power in the city. He writes about Qila Mubarak, or the Red Fort, and gives an account of the several buildings inside it and the cost of construction of the same. He ambles into the precincts and mentions the buildings constructed by Shahjahan and other rulers, associating them with some specific inmates of the fort and the functions performed within them. When the author takes a walk in the city of Shahjahanabad, he writes of numerous residents, habitations of rich, poor, and ordinary people, their mansions and localities, general and specialized bazars, the in different skills practised areas, places of worship and revelry, processions exemplifying popular culture and local traditions, and institutions that had a resonance in other cultures. The Berlin manuscript gives generous details of the officials of the English East India Company, both native and foreign, their professions, and work spaces. Mirza Sangin Beg addresses the issue of qaum most unselfconsciously and amorphously.

scholarly journals P129 The utility of routine operative swab culture in uncomplicated peri-anal abscesses

BJS Open ◽  
2021 ◽  
Vol 5 (Supplement_1) ◽  
Author(s):  
Apoorva Khajuria ◽  
Tuba Rahim ◽  
Mariam Baig ◽  
Kai Leong ◽  
Apoorva Khajuria
Keyword(s):  
Inflammatory Bowel Disease ◽  
Perianal Abscess ◽  
Female Ratio ◽  
Incision And Drainage ◽  
Common Presentation ◽  
History Of ◽  
Inflammatory Bowel ◽  
Operative Findings ◽  
The Cost ◽  
Male To Female

Abstract Introduction Despite perianal abscess being a common presentation, certain aspects of its management remain controversial, especially the routine use of intra-operative swab cultures. Methods A retrospective review of patients that underwent incision and drainage procedures for a perianal abscess over a six-month period was undertaken. Results Over 6 months, 50 patients were identified. The male to female ratio was 3:1 and median ASA score was 1. Only 6/50 patients presented with recurrent abscess and 1 patient had history of inflammatory bowel disease. On the basis of operative findings, 39 patients (78%) had uncomplicated abscess (not associated with cellulitis, sinus or fistula); swab cultures were performed in 26 (67%) of these patients. All patients were discharged on the same day; microbiology reports did not impact the treatment and no patients were followed up in clinic post-operatively or presented with recurrence. The number of unnecessary microbiology swabs undertaken in this cohort equates to approximately 52 unnecessary swabs a year. The cost of one swab is £10.10p, which means £520 could potentially be saved annually. Conclusion Routine intra-operative swab cultures do not impact management decisions, add to unnecessary costs and therefore should not be undertaken in uncomplicated or first presentation of peri-anal abscesses.

Empowering and Directive Leadership: The Cost of Changing Styles

2021 ◽  
pp. 227853372110083
Author(s):  
Smita Mukherjee ◽  
Zubin R. Mulla
Keyword(s):  
Laboratory Experiment ◽  
Leadership Styles ◽  
Leadership Style ◽  
Affective Commitment ◽  
Team Outcomes ◽  
History Of ◽  
Satisfaction With The Leader ◽  
The Cost ◽  
First Time

We examine the cost of leaders changing between empowering and directive leadership styles on team outcomes. In a laboratory experiment, we collected data from 240 participants in 80 teams. Confederates enacted different leadership styles and led teams of participants in performing a series of tasks. When leaders changed their style from directive to empowering, teams took time to respond in terms of higher satisfaction with leader and affective commitment. However, when leaders changed their style from empowering to directive, the deterioration of satisfaction with leader and reduction in affective commitment were immediate. Moreover, teams of leaders who had been consistently directive showed higher affective commitment as compared to teams of leaders who had a history of being empowering but later shifted to being directive. First time managers can get inputs on how they should enact their leadership style and be aware that switching between styles may impose long-term costs on the team’s affective commitment and satisfaction with the leader.

scholarly journals Evaluation of whole-body modalities for diagnosis of multifocal osteonecrosis—a pilot study

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Shunichi Yokota ◽  
Keita Sakamoto ◽  
Yukie Shimizu ◽  
Tsuyoshi Asano ◽  
Daisuke Takahashi ◽  
...  
Keyword(s):  
Study Data ◽  
Whole Body ◽  
Hematologic Disease ◽  
Hip Joints ◽  
Patient Demographics ◽  
Examination Time ◽  
History Of ◽  
Body Magnetic Resonance Imaging ◽  
The Cost ◽  
Body Bone

Abstract Background This study aimed to investigate the ability of whole-body bone scintigraphy (WB-BS) in the detection of multifocal osteonecrosis (ON) compared to whole-body magnetic resonance imaging (WB-MRI) and to clarify the characteristics of patients with multifocal ON among those with ON of the femoral head (ONFH) using WB-MRI. Methods Forty-six patients who had symptomatic ONFH and underwent surgery in our hospital from April 2019 to October 2020 were included in the study. Data on patient demographics, including age, sex, body mass index (BMI), history of corticosteroid intake, alcohol abuse, smoking, and symptomatic joints, were collected from their medical records. All patients underwent WB-MRI and WB-BS before surgery. Results The agreement in the detection of ON by WB-MRI vs the uptake lesions by WB-BS in the hip joints was moderate (κ = 0.584), while that in other joints was low (κ < 0.40). Among the 152 joints with ON detected by WB-MRI, 92 joints (60.5%) were symptomatic, and 60 joints (39.5%) were asymptomatic. Twelve out of the 46 (26.0%) patients had multifocal (three or more distinct anatomical sites) ON. Nonetheless, while WB-BS detected symptomatic ON detected by WB-MRI as uptake lesions in 82.6% (76/92) of the joints, asymptomatic ON detected by WB-MRI was detected as uptake lesions in 21.7% (13/60) of the joints. All patients with multifocal ON had a history of steroid therapy, which was significantly higher than that in patients with oligofocal ON (P = 0.035). The patients with a hematologic disease had multifocal ON at a higher rate (P = 0.015). Conclusions It might be difficult for WB-BS to detect the asymptomatic ON detected by WB-MRI compared to symptomatic ON. Considering the cost, examination time, and radiation exposure, WB-MRI might be useful for evaluating multifocal ON. Larger longitudinal studies evaluating the benefits of WB-MRI for detecting the risk factors for multifocal ON are required.

scholarly journals Severe Posaconazole-Induced Glucocorticoid Deficiency with Concurrent Pseudohyperaldosteronism: An Unfortunate Two-for-One Special

2021 ◽  
Vol 7 (8) ◽  
pp. 620
Author(s):  
Alejandro Villar-Prados ◽  
Julia J. Chang ◽  
David A. Stevens ◽  
Gary K. Schoolnik ◽  
Samantha X. Y. Wang
Keyword(s):  
Mechanism Of Action ◽  
Antifungal Agents ◽  
Laboratory Findings ◽  
Steroid Synthesis ◽  
Adrenal Steroid ◽  
History Of ◽  
Glucocorticoid Deficiency

A 56-year-old Hispanic man with a history of disseminated coccidioidomycosis was diagnosed with persistent glucocorticoid insufficiency and pseudohyperaldosteronism secondary to posaconazole toxicity. This case was notable for unexpected laboratory findings of both pseudohyperaldosteronism and severe glucocorticoid deficiency due to posaconazole’s mechanism of action on the adrenal steroid synthesis pathway. Transitioning to fluconazole and starting hydrocortisone resolved the hypokalemia but not his glucocorticoid deficiency. This case highlights the importance of recognizing iatrogenic glucocorticoid deficiency with azole antifungal agents and potential long term sequalae.

scholarly journals In the service of secrecy: An enveloped history of priority, proof and patents

2021 ◽  
pp. 135918352110288
Author(s):  
Eva Hemmungs Wirtén
Keyword(s):  
Intellectual Property ◽  
Early Modern ◽  
Property System ◽  
Private And Public ◽  
History Of ◽  
The Individual ◽  
Propriété Industrielle ◽  
The Cost ◽  
Double Envelope ◽  
Double Compartment

This article is about an everyday paper object: an envelope. However, as opposed to most other flat paper containers, the enveloppe Soleau can only be bought from L’Institut national de la propriété industrielle (INPI) in Paris. At the cost of €15 you get a perforated, double-compartment envelope allowing you to constitute proof of creation and assign a precise date to your idea or project. But the enveloppe Soleau is something much more than just a simple and cheap way by which you can prove priority in any creative domain. It is a material footprint anchored to centuries of practices associated with disclosure and secrecy, a gateway into the infrastructure of the intellectual property system and its complicated relationship to the forms of knowledge it purports to hold. The purpose of this article is to consider the making of the enveloppe Soleau as a bureaucratic document, a material device performing a particular kind of legal paperwork. In four different vignettes, the article tracks the material becoming of the enveloppe Soleau as an evidentiary receptacle, beginning by going back to early modern practices of secrecy and priority, continuing with its consolidation in two patents (from 1910 and 1911) to the inventor Eugène Soleau (1852–1929), and ending up, in 2016, dematerialized in the e-Soleau. As a bureaucratic document, the enveloppe Soleau shows just how much work a mundane paper object can perform, navigating a particular materiality (a patented double envelope); formalized processes of proof (where perforations have legal significance); the practices of double archiving (in an institution and with the individual) and strict temporal limitations (a decade). Ultimately, the enveloppe Soleau travels between the material and immaterial, between private and public, between secrecy and disclosure, but also between what we perceive of as the outside and inside of the intellectual property system.

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