This document summarizes a study examining the current and future needs and uses of flow cytometry. Over 260 flow cytometry users in 53 countries were surveyed about their current and planned applications, purchases, and budgets for flow cytometry over the next three years. Key findings of the study include details on users' main flow cytometry applications and systems, budgets, and requirements for innovation in areas like new clinical applications and biomarkers. The report provides insights into developing trends in the flow cytometry market through 2015.
Following topics are covered in this slide deck:
Role and use of Pharmacoeconomics and health outcomes research | Impact of price regulation in India | Factors affecting drug pricing | Need, challenges and components of pharmacoeconomics | Aims, Objectives and principle of Pharmacoeconomic Evaluation | Different types of cost measurement | The Methods of Pharmacoeconomic Evaluation | Cost Analysis (CUA)
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as a branch of health economics that compares the value of drug therapies. The key points covered include: pharmacoeconomics identifies, measures, and compares the costs and health outcomes of drug therapies; common perspectives in evaluation include patients, providers, payers, and society; and methodologies include cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Quality patient care requires balancing economic, humanistic, and clinical outcomes.
The document outlines the World Health Organization's first edition of the Model List of Essential In Vitro Diagnostics (EDL). The EDL provides guidance to countries on selecting important diagnostic tests to address disease priorities based on their health systems and needs. The EDL lists general diagnostic tests and disease-specific tests for primary healthcare facilities and facilities with clinical laboratories. It is intended to complement the WHO Model List of Essential Medicines and help improve access to quality diagnostics globally. Selection of tests was based on disease burden, unmet needs, and priorities. The EDL provides information on test purpose, format, specimens, recommended facility level, and links to WHO guidance and prequalified products. Countries should consider local factors in adapting
It is a sub-discipline of health economics , Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another.
Pharmacoeconomics deals with identifying, measuring, and comparing the costs and consequences of pharmaceutical products and services.
This document summarizes a study that used multi-criteria decision analysis (MCDA) to understand stakeholders' preferences on decision criteria for the treatment obinutuzumab for indolent non-Hodgkin lymphoma in Italy. Stakeholders including patients, clinicians, and payers participated in an online survey and meetings to provide weights and scores on criteria such as disease severity and cost. The results showed similarity between patients and clinicians prioritizing criteria related to disease impact, while payers distributed weights more evenly. Obinutuzumab scored highly on disease severity and therapeutic benefit but lower on economic criteria. The overall value score can help inform coverage decisions by identifying priority outcomes and consensus views.
Key factors driving access and uptake of hepatitis C treatments in Europe. Re...Office of Health Economics
This presentation summarises the results of experts interviews aiming to identify the key factors which have influenced the access and the uptake of direct acting antivirals (DAAs) in selected European countries. This qualitative piece of analysis was conducted as part of a larger project studying the development and the diffusion of innovation in the market of treatments for hepatitis C. The interviews shed light on the reimbursement strategies and other factors, relating to the ability of individual health care systems to supply the treatments, which may have influenced, positively of negatively, access and speed of uptake of DAAs in Europe.
Author(s) and affiliation(s): Margherita Neri, Office of Health Economics; Mikel Berdud, Office of Health Economics; Martina Garau, Office of Health Economics; Phill O’Neill, Office of Health Economics; Chris Sampson, Office of Health Economics; Adrian Towse, Office of Health Economics.
Conference/meeting: EuHEA Conference 2018
Location: Maastricht, Netherlands
Date: 11/07/2018
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
Following topics are covered in this slide deck:
Role and use of Pharmacoeconomics and health outcomes research | Impact of price regulation in India | Factors affecting drug pricing | Need, challenges and components of pharmacoeconomics | Aims, Objectives and principle of Pharmacoeconomic Evaluation | Different types of cost measurement | The Methods of Pharmacoeconomic Evaluation | Cost Analysis (CUA)
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as a branch of health economics that compares the value of drug therapies. The key points covered include: pharmacoeconomics identifies, measures, and compares the costs and health outcomes of drug therapies; common perspectives in evaluation include patients, providers, payers, and society; and methodologies include cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Quality patient care requires balancing economic, humanistic, and clinical outcomes.
The document outlines the World Health Organization's first edition of the Model List of Essential In Vitro Diagnostics (EDL). The EDL provides guidance to countries on selecting important diagnostic tests to address disease priorities based on their health systems and needs. The EDL lists general diagnostic tests and disease-specific tests for primary healthcare facilities and facilities with clinical laboratories. It is intended to complement the WHO Model List of Essential Medicines and help improve access to quality diagnostics globally. Selection of tests was based on disease burden, unmet needs, and priorities. The EDL provides information on test purpose, format, specimens, recommended facility level, and links to WHO guidance and prequalified products. Countries should consider local factors in adapting
It is a sub-discipline of health economics , Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another.
Pharmacoeconomics deals with identifying, measuring, and comparing the costs and consequences of pharmaceutical products and services.
This document summarizes a study that used multi-criteria decision analysis (MCDA) to understand stakeholders' preferences on decision criteria for the treatment obinutuzumab for indolent non-Hodgkin lymphoma in Italy. Stakeholders including patients, clinicians, and payers participated in an online survey and meetings to provide weights and scores on criteria such as disease severity and cost. The results showed similarity between patients and clinicians prioritizing criteria related to disease impact, while payers distributed weights more evenly. Obinutuzumab scored highly on disease severity and therapeutic benefit but lower on economic criteria. The overall value score can help inform coverage decisions by identifying priority outcomes and consensus views.
Key factors driving access and uptake of hepatitis C treatments in Europe. Re...Office of Health Economics
This presentation summarises the results of experts interviews aiming to identify the key factors which have influenced the access and the uptake of direct acting antivirals (DAAs) in selected European countries. This qualitative piece of analysis was conducted as part of a larger project studying the development and the diffusion of innovation in the market of treatments for hepatitis C. The interviews shed light on the reimbursement strategies and other factors, relating to the ability of individual health care systems to supply the treatments, which may have influenced, positively of negatively, access and speed of uptake of DAAs in Europe.
Author(s) and affiliation(s): Margherita Neri, Office of Health Economics; Mikel Berdud, Office of Health Economics; Martina Garau, Office of Health Economics; Phill O’Neill, Office of Health Economics; Chris Sampson, Office of Health Economics; Adrian Towse, Office of Health Economics.
Conference/meeting: EuHEA Conference 2018
Location: Maastricht, Netherlands
Date: 11/07/2018
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
This document discusses scenario-building methods to define the future of clinical evidence requirements in the US drug development and healthcare systems. It identifies key factors like integration of health systems, use of big data, and patient roles that could impact clinical evidence requirements. Three potential scenarios are described ranging from a status quo system to a fully integrated system. The "moderate integration" scenario is deemed most likely, featuring some increased system integration, standardized electronic health records, growing big data opportunities, and more organized patient groups. Accountable care organizations are also examined, finding they may evaluate drug effectiveness and cost-effectiveness as risk-based payments increase and care pathways are established.
The document discusses the EHR4CR project, which aims to develop a trustworthy service platform to access clinical information from electronic health records (EHRs) to improve clinical research. The project has developed a scalable platform used in pilot programs across 11 major hospitals in 5 countries. It is working to expand this platform into a pan-European network to support clinical trial feasibility studies, patient recruitment, and other research activities. Key stakeholders include hospitals, pharmaceutical companies, and the newly formed European Institute for Innovation through Health Data, which will help govern the platform. The goals are to increase clinical trial efficiency, reduce costs, and improve patient care through better use of EHR data for research.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as the application of economic analysis to pharmaceutical products and services, focusing on costs and outcomes. The document then covers:
- The history and perspectives of pharmacoeconomics
- Common methodologies like cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis
- How pharmacoeconomics can be applied at different stages of drug development and to support pricing and reimbursement decisions
- The relationships between pharmacoeconomics, outcomes research, and pharmaceutical care
In 3 sentences or less, this document summarizes key concepts in pharmacoeconomics like its definition, common methodologies, and applications in drug
This document provides an overview of pharmacoeconomics, including its history, definitions, types of evaluations, and limitations. Pharmacoeconomics developed in the 1970s to analyze the costs of drug therapy. It is concerned with the economic impact of pharmaceutical products and services on individuals, health systems, and society. There are several types of pharmacoeconomic evaluations including cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis, which are used to compare drug programs and therapies. Pharmacoeconomic studies can be conducted during various phases of drug development and are used by industry, government, and private sectors to make decisions about research, pricing, and insurance coverage.
This document summarizes Professor Adrian Towse's presentation on assessing the value of new antibiotics. It discusses the challenges of developing new antibiotics due to scientific and economic hurdles. Current health technology assessment frameworks may not fully capture antibiotics' value in addressing antimicrobial resistance. Additional elements of value for antibiotics are proposed, including insurance value, diversity value, and enablement value. Evidence requirements for assessing these new elements were discussed. While not unique to antibiotics, these elements provide a more comprehensive evaluation. Further refinement is needed to incorporate these elements into health technology assessments.
The Value of Knowing and Knowing the Value: Improving the Health Technology A...Office of Health Economics
1) The document discusses improving the health technology assessment (HTA) of complementary diagnostics by considering a more comprehensive perspective of their value.
2) It identifies gaps in how HTA bodies currently evaluate complementary diagnostics, failing to fully account for the value of diagnostic information.
3) The document proposes recommendations to change HTA practices including broadening evidentiary requirements to consider clinical utility more fully, exploring value-based pricing approaches, and addressing barriers to uptake of complementary diagnostics.
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
This document discusses pharmacoeconomics and provides definitions, principles, perspectives, types of costs and consequences, and methods of pharmacoeconomic evaluation. Pharmacoeconomics analyzes the costs and benefits of drug therapies to health systems and society. It considers costs from multiple perspectives including patients, providers, payers, and society. Costs include direct medical, direct non-medical, and indirect costs. Consequences include clinical, economic, and humanistic outcomes. Common methods of pharmacoeconomic evaluation are cost-of-illness analysis, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These methods are used to inform healthcare decisions at both the individual patient
This document provides an overview of pharmacoeconomics and discusses different types of pharmacoeconomic analyses including cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. It describes key components of pharmacoeconomic studies such as assessing costs, measuring outcomes, perspectives, and discount rates. Examples are provided to illustrate cost-minimization analysis and cost-benefit analysis.
This document discusses principles of pharmacoeconomics and their impact on pharmaceutical research and development. It describes how pharmacoeconomic evaluations measure health gains and costs to compare medical procedures. Randomized controlled trials are required to prove efficacy and safety, but real-world studies are also needed to evaluate long-term health benefits and costs. Economic modeling can be used alongside clinical trials to estimate benefits like quality-adjusted life years to determine appropriate pricing and reimbursement strategies for new drugs. Understanding pharmacoeconomics principles is important for pharmaceutical R&D decision making.
This document summarizes a study examining economic evaluations submitted to the pan-Canadian Oncology Drug Review (pCODR). The study identified the most common methodological issues reported in pCODR's economic guidance reports between 2011-2014. The main issues included time horizon, drug wastage costs, utility estimates, and model structure/extrapolation methods. While some issues could be addressed, others like model structure and data quality were often unresolved. The study found correlations between some issues and funding recommendations, but noted recommendations are influenced by multiple factors beyond economic evaluations.
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
This document discusses EU regulations regarding clinical investigations for medical devices. It provides definitions for key terms like clinical data, clinical use, sufficient clinical evidence, and clinical investigation. It explains that premarket clinical investigations are often required for implants, high-risk devices, and those extending intended use, while postmarket studies follow CE marking to answer safety or performance questions. Clinical investigations must meet requirements like having a protocol, informed consent, qualifications of investigators, and reporting adverse events. The conclusion is that the EU demands higher clinical evidence throughout a product's lifecycle compared to other regions.
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document provides an overview of pharmacoeconomics. It defines key terms like health economics and pharmacoeconomics. It discusses the history and components of pharmacoeconomics. The document outlines different types of costs, perspectives, and methodologies used in pharmacoeconomics like cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It also discusses the need, applications, and challenges of pharmacoeconomics evaluations.
Pharmacoeconomic Assessment through Market Approval and BeyondJennifer Hammonds
This presentation discusses pharmacoeconomic assessment through different phases of drug development and approval. It provides an overview of different types of pharmacoeconomic analyses including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and budget impact modeling. It emphasizes the importance of real-world pharmacoeconomic assessment to demonstrate the true cost-effectiveness and safety of drugs based on real-world data rather than clinical trials alone. The presentation outlines considerations for planning and implementing real-world pharmacoeconomic assessments, including study design, data collection from multiple sources like electronic health records, and ongoing analysis of updated data streams.
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
Aoac practices for microbiological methodology - 2006[2]Sc Nscp
This document provides a summary of the recommendations from the AOAC International Presidential Task Force on Best Practices for Microbiological Methodology (BPMM). The task force was formed to evaluate the technical and statistical aspects of AOAC and ISO guidelines for validating microbiological methods and to recommend new approaches. The task force comprised a steering committee and four working groups that addressed objectives related to expanding validations to new foods/strains, developing performance standards, reasonable validation criteria for attribute/quantitative/process control testing, determining detection limits and characterizing performance near detection limits, accounting for biological variation, and articulating uncertainty. Key recommendations include new food categorization schemes for determining validation requirements for new matrices, lists of essential reference organisms, basing
This document summarizes an official methods of analysis publication from 1980. It has been incorporated by reference and is legally binding for US citizens. The publication contains standardized methods for analyzing various agricultural and food products developed by the Association of Official Analytical Chemists (AOAC) through collaborative studies. It provides methods for analyzing products like fertilizers, plants, disinfectants, hazardous substances, and pesticide formulations. The summarized document establishes the referenced publication as an authoritative source for analytical testing in the United States.
This document discusses the topic of pharmacoeconomics. It begins with introducing health economics and defining pharmacoeconomics as the analysis of the costs and benefits of drug therapy. It then outlines different types of pharmacoeconomic evaluations including partial evaluations like cost-of-illness and cost-consequence analyses, as well as full evaluations like cost-minimization, cost-benefit, cost-effectiveness, and cost-utility analyses. Specific examples are provided for some of these evaluation types. The document also discusses the importance of pharmacoeconomics and references organizations like ISPOR and NCPE.
A empresa de tecnologia anunciou um novo smartphone com câmera aprimorada, tela maior e bateria de longa duração por um preço acessível. O dispositivo tem como objetivo atrair mais consumidores em mercados emergentes com suas especificações equilibradas e preço baixo. Analistas esperam que as melhorias e o preço baixo impulsionem as vendas do novo aparelho.
Non-Life Insurance in Portugal, Key Trends and Opportunities to 2016ReportsnReports
This report provides an in-depth analysis of the non-life insurance market in Portugal from 2007 to 2016. It details key trends such as declining premiums in the property and motor insurance categories due to economic factors. The report also examines the competitive landscape and profiles major players such as Fidelidade-Mundial. It aims to help readers make strategic business decisions and identify growth opportunities within the Portuguese non-life insurance sector.
This document discusses scenario-building methods to define the future of clinical evidence requirements in the US drug development and healthcare systems. It identifies key factors like integration of health systems, use of big data, and patient roles that could impact clinical evidence requirements. Three potential scenarios are described ranging from a status quo system to a fully integrated system. The "moderate integration" scenario is deemed most likely, featuring some increased system integration, standardized electronic health records, growing big data opportunities, and more organized patient groups. Accountable care organizations are also examined, finding they may evaluate drug effectiveness and cost-effectiveness as risk-based payments increase and care pathways are established.
The document discusses the EHR4CR project, which aims to develop a trustworthy service platform to access clinical information from electronic health records (EHRs) to improve clinical research. The project has developed a scalable platform used in pilot programs across 11 major hospitals in 5 countries. It is working to expand this platform into a pan-European network to support clinical trial feasibility studies, patient recruitment, and other research activities. Key stakeholders include hospitals, pharmaceutical companies, and the newly formed European Institute for Innovation through Health Data, which will help govern the platform. The goals are to increase clinical trial efficiency, reduce costs, and improve patient care through better use of EHR data for research.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as the application of economic analysis to pharmaceutical products and services, focusing on costs and outcomes. The document then covers:
- The history and perspectives of pharmacoeconomics
- Common methodologies like cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis
- How pharmacoeconomics can be applied at different stages of drug development and to support pricing and reimbursement decisions
- The relationships between pharmacoeconomics, outcomes research, and pharmaceutical care
In 3 sentences or less, this document summarizes key concepts in pharmacoeconomics like its definition, common methodologies, and applications in drug
This document provides an overview of pharmacoeconomics, including its history, definitions, types of evaluations, and limitations. Pharmacoeconomics developed in the 1970s to analyze the costs of drug therapy. It is concerned with the economic impact of pharmaceutical products and services on individuals, health systems, and society. There are several types of pharmacoeconomic evaluations including cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis, which are used to compare drug programs and therapies. Pharmacoeconomic studies can be conducted during various phases of drug development and are used by industry, government, and private sectors to make decisions about research, pricing, and insurance coverage.
This document summarizes Professor Adrian Towse's presentation on assessing the value of new antibiotics. It discusses the challenges of developing new antibiotics due to scientific and economic hurdles. Current health technology assessment frameworks may not fully capture antibiotics' value in addressing antimicrobial resistance. Additional elements of value for antibiotics are proposed, including insurance value, diversity value, and enablement value. Evidence requirements for assessing these new elements were discussed. While not unique to antibiotics, these elements provide a more comprehensive evaluation. Further refinement is needed to incorporate these elements into health technology assessments.
The Value of Knowing and Knowing the Value: Improving the Health Technology A...Office of Health Economics
1) The document discusses improving the health technology assessment (HTA) of complementary diagnostics by considering a more comprehensive perspective of their value.
2) It identifies gaps in how HTA bodies currently evaluate complementary diagnostics, failing to fully account for the value of diagnostic information.
3) The document proposes recommendations to change HTA practices including broadening evidentiary requirements to consider clinical utility more fully, exploring value-based pricing approaches, and addressing barriers to uptake of complementary diagnostics.
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
This document discusses pharmacoeconomics and provides definitions, principles, perspectives, types of costs and consequences, and methods of pharmacoeconomic evaluation. Pharmacoeconomics analyzes the costs and benefits of drug therapies to health systems and society. It considers costs from multiple perspectives including patients, providers, payers, and society. Costs include direct medical, direct non-medical, and indirect costs. Consequences include clinical, economic, and humanistic outcomes. Common methods of pharmacoeconomic evaluation are cost-of-illness analysis, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These methods are used to inform healthcare decisions at both the individual patient
This document provides an overview of pharmacoeconomics and discusses different types of pharmacoeconomic analyses including cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. It describes key components of pharmacoeconomic studies such as assessing costs, measuring outcomes, perspectives, and discount rates. Examples are provided to illustrate cost-minimization analysis and cost-benefit analysis.
This document discusses principles of pharmacoeconomics and their impact on pharmaceutical research and development. It describes how pharmacoeconomic evaluations measure health gains and costs to compare medical procedures. Randomized controlled trials are required to prove efficacy and safety, but real-world studies are also needed to evaluate long-term health benefits and costs. Economic modeling can be used alongside clinical trials to estimate benefits like quality-adjusted life years to determine appropriate pricing and reimbursement strategies for new drugs. Understanding pharmacoeconomics principles is important for pharmaceutical R&D decision making.
This document summarizes a study examining economic evaluations submitted to the pan-Canadian Oncology Drug Review (pCODR). The study identified the most common methodological issues reported in pCODR's economic guidance reports between 2011-2014. The main issues included time horizon, drug wastage costs, utility estimates, and model structure/extrapolation methods. While some issues could be addressed, others like model structure and data quality were often unresolved. The study found correlations between some issues and funding recommendations, but noted recommendations are influenced by multiple factors beyond economic evaluations.
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
This document discusses EU regulations regarding clinical investigations for medical devices. It provides definitions for key terms like clinical data, clinical use, sufficient clinical evidence, and clinical investigation. It explains that premarket clinical investigations are often required for implants, high-risk devices, and those extending intended use, while postmarket studies follow CE marking to answer safety or performance questions. Clinical investigations must meet requirements like having a protocol, informed consent, qualifications of investigators, and reporting adverse events. The conclusion is that the EU demands higher clinical evidence throughout a product's lifecycle compared to other regions.
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document provides an overview of pharmacoeconomics. It defines key terms like health economics and pharmacoeconomics. It discusses the history and components of pharmacoeconomics. The document outlines different types of costs, perspectives, and methodologies used in pharmacoeconomics like cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It also discusses the need, applications, and challenges of pharmacoeconomics evaluations.
Pharmacoeconomic Assessment through Market Approval and BeyondJennifer Hammonds
This presentation discusses pharmacoeconomic assessment through different phases of drug development and approval. It provides an overview of different types of pharmacoeconomic analyses including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and budget impact modeling. It emphasizes the importance of real-world pharmacoeconomic assessment to demonstrate the true cost-effectiveness and safety of drugs based on real-world data rather than clinical trials alone. The presentation outlines considerations for planning and implementing real-world pharmacoeconomic assessments, including study design, data collection from multiple sources like electronic health records, and ongoing analysis of updated data streams.
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
Aoac practices for microbiological methodology - 2006[2]Sc Nscp
This document provides a summary of the recommendations from the AOAC International Presidential Task Force on Best Practices for Microbiological Methodology (BPMM). The task force was formed to evaluate the technical and statistical aspects of AOAC and ISO guidelines for validating microbiological methods and to recommend new approaches. The task force comprised a steering committee and four working groups that addressed objectives related to expanding validations to new foods/strains, developing performance standards, reasonable validation criteria for attribute/quantitative/process control testing, determining detection limits and characterizing performance near detection limits, accounting for biological variation, and articulating uncertainty. Key recommendations include new food categorization schemes for determining validation requirements for new matrices, lists of essential reference organisms, basing
This document summarizes an official methods of analysis publication from 1980. It has been incorporated by reference and is legally binding for US citizens. The publication contains standardized methods for analyzing various agricultural and food products developed by the Association of Official Analytical Chemists (AOAC) through collaborative studies. It provides methods for analyzing products like fertilizers, plants, disinfectants, hazardous substances, and pesticide formulations. The summarized document establishes the referenced publication as an authoritative source for analytical testing in the United States.
This document discusses the topic of pharmacoeconomics. It begins with introducing health economics and defining pharmacoeconomics as the analysis of the costs and benefits of drug therapy. It then outlines different types of pharmacoeconomic evaluations including partial evaluations like cost-of-illness and cost-consequence analyses, as well as full evaluations like cost-minimization, cost-benefit, cost-effectiveness, and cost-utility analyses. Specific examples are provided for some of these evaluation types. The document also discusses the importance of pharmacoeconomics and references organizations like ISPOR and NCPE.
A empresa de tecnologia anunciou um novo smartphone com câmera aprimorada, tela maior e bateria de longa duração por um preço acessível. O dispositivo tem como objetivo atrair mais consumidores em mercados emergentes com suas especificações equilibradas e preço baixo. Analistas esperam que as melhorias e o preço baixo impulsionem as vendas do novo aparelho.
Non-Life Insurance in Portugal, Key Trends and Opportunities to 2016ReportsnReports
This report provides an in-depth analysis of the non-life insurance market in Portugal from 2007 to 2016. It details key trends such as declining premiums in the property and motor insurance categories due to economic factors. The report also examines the competitive landscape and profiles major players such as Fidelidade-Mundial. It aims to help readers make strategic business decisions and identify growth opportunities within the Portuguese non-life insurance sector.
Summify is a service that creates a daily summary of the most relevant news stories from a user's social networks, condensing them into a beautiful summary. The summary contains around 800 words per day and highlights 150 of the most important stories. Users can sign up for the Summify service at http://summify.com to receive these daily personalized news summaries.
This report analyzes the global battery industry, providing historical demand data from 2001-2011 and forecasts through 2021. It finds that worldwide battery demand is expected to rise 8.5% annually through 2016 to $144 billion, driven by growth in China, India, and consumer markets. While battery prices increased rapidly from 2006-2011, reduced pricing pressure going forward will slow the rate of value gains in the battery industry. Demand for secondary batteries like lithium-ion is forecast to outpace primary batteries due to expanding portable electronics and electric vehicle use.
A Operação Overlord foi lançada em 1944 para libertar a Europa da ocupação nazista. As tropas aliadas enfrentaram forte resistência alemã no desembarque na Normandia no Dia D, mas eventualmente conseguiram libertar cidades como Caen, Paris e Bruxelas em sua corrida para derrotar Hitler em Berlim em 1945.
This document appears to be about an artist named Andris Eglitis and his 1959 artwork titled "Click Pps Series." The document also mentions "Çelebi Grubu" but provides no other context or details about the content.
O documento descreve as ferramentas e iniciativas de inovação em governo no estado de São Paulo ao longo dos anos, incluindo capacitação de servidores, eventos, e a implementação formal da política de gestão do conhecimento e inovação em 2009.
El documento contiene una lista de eventos y actividades que ocurrieron en un departamento de educación preescolar durante el año escolar 2009/2010, incluyendo el Día de la Alimentación, Navidad, Carnaval, visitas de un escritor y un obispo, la Semana de la Lectura, siembra de semillas, y ensayos de un coro para un sarao.
A araucária é uma árvore típica da Mata Atlântica brasileira que abriga diversos animais como papagaios, micos, tucanos e serpentes. O fragmento florestal descrito é habitat de espécies ameaçadas como a onça pintada e sofre pressões de desmatamento.
Social protection linking policy and strategic trajectories social capital ...Costy Costantinos
Using investigative methods of human feelings of wellness via direct survey of economic, environmental, physical, mental, workplace, social and political wellness metrics, the theme of the research underpins the determination of linkages between policy and strategies and civic en-gagement to spawn social protection mechanisms. The research is predicated on developing tools for stemming the stresses and shocks administered by the degree and speed of impoverishment that has posed enormous challenges for nations and peoples. The influence of global competition, social re-engineering, political and military conflicts and power shifts exert enormous pressure on the psyche of the average individual and family. The results from the survey were computed using the seven satisfaction metrics. While more has changed in the last decade technologically, culturally, politically and economically than the entire past century, responses from key informants by and large show a general level of life satisfaction among the selected population of lowest to highest incomes categories, using the Gross National Happiness approach. Life wellness measurement fares better compared to Gross Domestic Product as it shows satisfaction level and helps self-targeting in public works designed as employment generating safety nets.
The document discusses Vodafone's advertising campaign featuring a new mascot, the Zoozoos. It introduced aliens as brand ambassadors to promote Vodafone's services in a humorous and entertaining way. The ads were very successful especially among youth and only cost around 3 crores to produce, less than animated ads. However, some found the ads unclear about what service was being advertised and the company name was only shown briefly at the end.
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Flow Cytometry 2012: Market Needs, Emerging Developments and Future Use
1. Flow Cytometry 2012: Market Needs, Emerging Developments
and Future Use
Report Details:
Published:September 2012
No. of Pages:
Price: Single User License – US$2355
Biopharm Reports has carried out a study of market needs in the flow cytometry field. This study
examined current techniques and applications, end-users’ plans for using flow cytometry over the
next three years, as well as preferred products, purchasing and new developments. The findings
of this study provide valuable support to developers and vendors operating in this field.
This study involved the participation of 260 experienced flow cytometry users and decision-makers
in 53 countries. It investigated current and future applications, current and future purchasing plans,
research vs. clinical use across the study, new and emerging applications, end-users’ principal
flow cytometers and their strengths and weaknesses, current annual and future budgets, budget
breakdown, main consumables, challenges, innovation, use of analysis (offline) software, quality
control guidelines, sample preparation, and other areas. As part of this study, end-users provided
details of their anticipated purchases from suppliers in this field, over the period 2012 – 2015.
Key Findings
•Routine use: Use of flow cytometry (FC) by end-users for routine (developed and validated) FC
tests, the development or validation of FC tests and for qualitative discovery using FC methods.
•Companies: End-users' purchases/use of FC systems from more than 25 companies and their
anticipated use of these systems over the next three years, each ranked according to their
competitive position
•General and clinical: FC use (defined in this study description) by research scientists/research
managers and clinicians/physicians
•FC methods: Current use of more than 25 FC general applications and 15 clinical applications by
end-users and the anticipated use of these applications over the next three years, each ranked
according to their competitive position.
•Main applications: End-users’ two main applications of FC, each ranked according to their
competitive position.
•New applications: New FC applications used by end-users in the last three years, each ranked
according to their competitive position.
•Emerging applications: Emerging applications of FC, indicated by end-users.
•Main flow cytometer: End-users’ main flow cytometer, each ranked according to their competitive
position.
2. •Strengths: End-users’ disclosures of the strengths of their main flow cytometer, each ranked
according to their competitive position.
•Weaknesses: End-users’ disclosures of the weaknesses of their main flow cytometer, each
ranked according to their competitive position.
•Current financial budgets: End-users’ annual financial budgets for FC studies.
•Current budget breakdown: The breakdown of end-users’ FC financial budgets in nine key areas,
relating to their current expenditure on FC products and activities.
•Future financial budgets: End-users’ anticipated financial budget changes (percentage increases
or decrease, a measure of the financial growth of this field) over the next three years, relating to
their FC activities.
•Consumables: End-users’ top consumables, associated with their FC activities.
•Quality control guidelines: End-users’ adherence to quality control guidelines or procedures,
relating to the conduct of FC studies.
•Cost per sample: End-users’ disclosures on the costs per sample analysed, using FC.
•Current challenges: End-users’ disclosures on the parameters or measurements that present the
greatest technical challenges to FC analysis, together with the associated sample types
(matrices), associated FC methods and underlying reasons.
•Innovation: End-users’ disclosures relating to 11 key areas of required innovation in the FC field,
each ranked (on a scale of 1 to 10) according to their importance.
•Biomarkers: End-users’ application of FC methods for the study of disease biomarkers, namely
molecular types and their clinical utilities.
•Organisations: End-users organisations include clinics or hospitals, government bodies, large
international companies, research institutes, small and medium sized companies, universities and
veterinary centres.
•Fields: End-users professional fields include biotechnology, chemicals, clinical or hospital,
defence, energy, environmental, food and drink, forensics, geology, government, healthcare,
natural products, pharmaceuticals, research institutes, security and universities.
•Therapeutic areas: End-users’ FC activities in terms of their general therapeutic area (20 different
areas covered), including the main diseases to which their work in this field relates.
•Software: End-users’ disclosures on their preferred analysis (off-line) software, associated with
FC studies.
•Purpose: End-users’ underlying reasons for using FC analysis across 17 major fields
(biotechnology, chemicals, clinical or hospital, defence, diagnostics (medical), energy,
environmental, food and drink, forensics, geology, government, healthcare, natural products,
pharmaceuticals, research institutes, security, university), each ranked according to their relative
importance.
•Study samples: Study sample types analysed by end-users using FC methods, each ranked
according to their relative importance.
•Sample preparation: The use of sample preparation methods by end-users for FC studies, each
ranked according to their importance.
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http://www.reportsnreports.com/reports/191887-flow-cytometry-2012-market-needs-emerging-developments-and-
future-use.html
Major points covered in Table of Contents of this report include
Table of Contents
1 Introduction
2 Study Participants
Investigated: Participants’ countries, regions, organisation types, departments and professional
fields. Figures and/or tables are also presented.
2.1 This chapter
2.2 Countries
2.3 Regions
2.4 Organisation types
2.5 Departments
2.6 Fields
2.7 Discussion
Fields:
Biotechnology
Chemicals
Clinical or Hospital
Defense
Diagnostics (Medical)
Energy
Environmental
Food and Drink
Forensics
Geology
Government
Healthcare
Natural Products
Pharmaceuticals
Research Institute
Security
University
Other
Organisation Types
University
Research Institute
Small or Medium Sized Company
Large International Company
Clinic or Hospital
Government Organisation
4. Veterinary Organisation
Other
3 Purpose of Flow Cytometry
Investigated: Participants’ purpose or reasons for using flow cytometry in their specified fields (see
Fields, Chapter 2). The purposes or reasons for using flow cytometry, which may be unique to
particular fields, were taken into account. Example: The purpose or reasons for using flow
cytometry in the “Clinical or Hospital” field were clinical research, routine diagnostics, routine
screening, clinical trials, treatment monitoring, diagnostics research, disease research, drug R&D,
drug targets, pathology, toxicology and other. Figures and/or tables are also presented.
3.1 This chapter
3.2 Purpose
3.3 Discussion
4 Main Activities
Investigated: The professional roles of study participants, namely as researchers or research
managers, clinicians or physicians. Figures and/or tables are also presented.
4.1 This chapter
4.2 Researchers or Research Managers
4.3 Clinicians or Physicians
4.4 Discussion
5 Flow Cytometric Tests
Investigated: Participants’ use of flow cytometry in one of three areas, namely i) the running of
routine cytometric tests ii) the developing of new cytometric tests or iii) qualitative (cytometric)
discovery. Figures and/or tables are also presented.
5.1 This chapter
5.2 Flow cytometric tests
5.3 Discussion
6 Therapeutic Area
Investigated: The therapeutic area(s) in which study participants work, relating to their use of flow
cytometry. Figures and/or tables are also presented.
6.1 This chapter
6.2 Therapeutic Areas
6.3 Discussion
Therapeutic Areas
Arthritis
Autoimmune Diseases
Bone Metabolism
Cancer
Cardiovascular
Central Nervous System
Dentistry
Dermatology
Endocrine
5. Gastrointestinal
Genito-urinary System
Haematology
Infections
Inflammation
Metabolic Disorders
Musculoskeletal Disorders
Nutrition
Obstetrics and Gynaecology
Ophthalmology
Pain
Psychiatry
Respiratory
Skin
Other
7 Main Diseases
Investigated: The main disease areas in which study participants work, relating to their use of flow
cytometry. Figures and/or tables are also presented.
7.1 This chapter
7.2 Disease areas
7.3 Discussion
8 Samples
Investigated: The sample types analysed by study participants, using flow cytometry. Figures
and/or tables are also presented.
8.1 This chapter
8.2 Samples
8.3 Discussion
Sample Types
Animal tissues
Cerebrospinal fluid
Bone Marrow
Human tissues
Microbiological materials
Pathology samples
Plant materials
Lymph
Saliva
Urine
Whole blood
Other
9 General Applications
Investigated: Participants current and anticipated future use (2012 – 2015) of flow cytometry, in
6. respect of 26 specified general applications, or others. Figures and/or tables are also presented.
9.1 This chapter
9.2 Current general applications
9.3 Anticipated future general applications
9.4 Discussion
General Application Areas
ADME Studies
Toxicity studies
Apoptosis
Bacteria analysis
Bacterial membrane potential
Bead-based immunoassays
Cell adherence
Cell cycle
Cell signalling
Cell sorting
Cellular kinetics
DNA and RNA content
Protein expression
FRET
Immunophenotyping
Intracellular calcium flux
Membrane asymmetry
Mitochondrial membrane potential
Multicolour Flow Cytometry
Necrosis
Organelle function
Protein expression and localization
Rare event analysis
Stem cell research
T Cell immunology
Transgenic products (e.g. GFP)
Other
10 Clinical Applications
Investigated: Participants current and anticipated future use (2012 – 2015) of flow cytometry, in
respect of 19 specified clinical applications, or others. Figures and/or tables are also presented.
10.1 This chapter
10.2 Current clinical applications
10.3 Anticipated future clinical applications
10.4 Discussion
Clinical Applications
Cell counting
7. Cell function
Cell pigments
Cell Proliferation
Cell surface antigens (e.g. CD markers)
Cell viability
Diagnosis of haematologic malignancies
DNA ploidy
Enzymatic activity
Infectious diseases
Intracellular antigens
Minimal residual disease
Monitoring AIDS patients
Monitoring chemotherapy
Multidrug Resistance (MDR)
Organ or stem-cell transplantation
Platelet function analysis
Transfusion medicine
Volume and morphology of cells
Other
11 Main Applications
Investigated: Participants main flow cytometry applications. Figures and/or tables are also
presented.
11.1 This chapter
11.2 Main applications
11.3 Discussion
12 New Applications
Investigated: New flow cytometry applications that study participants anticipate they will be using
in the next three years. Figures and/or tables are also presented.
12.1 This chapter
12.2 New applications
12.3 Discussion
13 Emerging Applications
Investigated: Emerging flow cytometry applications that study participants believe offer promise in
their field. Figures and/or tables are also presented.
13.1 This chapter
13.2 Emerging applications
13.3 Discussion
14 Suppliers
Investigated: Participants current and an anticipated future (2012 – 2015) flow cytometry suppliers
or vendors, in respect of 20 specified companies, or others. Figures and/or tables are also
presented.
14.1 This chapter
8. 14.2 Current suppliers
14.3 Future suppliers
14.4 Discussion
Suppliers
Amnis (Millipore)
Apogee Flow
Applied Bioscience
BD
Beckman Coulter
BioCytex
Bio-Rad
CytonomeST
DVS Sciences
iCyt (Sony)
IntelliCyt
Life Technologies
Luminex
Miltenyi
Partec
PointCare
Stratedigm
Sysmex
TTP LabTech
Union Biometrica
Other
15 Main Flow Cytometer, Strengths and Weaknesses
Investigated: Participants main flow cytometer, in terms of their most frequently used system,
together with their strengths and weaknesses. Figures and/or tables are also presented.
15.1 This chapter
15.2 Main flow cytometer
15.3 Discussion
16 Reagents and Assays
Investigated: Participants two main suppliers of reagents and assays for use in flow cytometry.
Figures and/or tables are also presented.
16.1 This Chapter
16.2 Reagents and assays
16.3 Discussion
17 Sample Preparation
Investigated: Sample preparation methods used by participants, for flow cytometry studies.
Figures and/or tables are also presented.
10.1 This Chapter
10.2 Sample Preparation
9. 10.3 Discussion
18 Software
Investigated: Participants use of data analysis (offline) software, for flow cytometry studies.
Figures and/or tables are also presented.
18.1 This Chapter
18.2 Software
18.3 Discussion
19 Challenges
Investigated: The measurements or parameters that present the greatest technical challenge to
study participants, relating to their use of flow cytometry. The parameter, sample type (matrix) and
cytometer used were indicated, together with the main underlying reasons. Figures and/or tables
are also presented.
19.1 This chapter
19.2 Parameters
19.3 Sample type (matrix)
19.4 Flow cytometer
19.5 Reasons
19.6 Discussion
20 Innovation
Investigated: Participants views on areas of required innovation (ranked on a scale of 1 to 10,
where 1 is the least important and 10 is the most important), in respect of 10 specified areas, or
others. Figures and/or tables are also presented.
20.1 This chapter
20.2 Innovation
20.3 Discussion
Innovation Areas
Automation
Detectors
Fluidics
Lasers/Light Sources
Offline (Analysis) software
Online Data handling
Qualitative selectivity
Quantitative sensitivity
Reagents
Sample preparation
Other
21 Disease Biomarkers
Investigated: Participants two main biomarkers investigated or measured using flow cytometry and
their applications in terms of nine clinical utilities. Figures and/or tables are also presented.
21.1 This chapter
21.2 Biomarkers
10. 21.3 Clinical utility
21.4 Discussion
Clinical Utilities
Disease prognosis
Disease susceptibility or risk
Disease stage or severity
Drug discovery
Early detection of disease
Clinical trial endpoint
Guiding treatment
Response to therapy
Safety or toxicity factors
Other
22 Flow Cytometry Expenditure and Budgets
Investigated: Financial expenditure and budgets relating to the current and future use of flow
cytometry, including end-users’ current annual budgets across specified ranges (see Current
Annual financial budgets), the average flow cytometry analysis costs/sample across specified
ranges (see Flow Cytometry Costs per Sample), budget breakdown across nine specified areas
(see Budget Breakdown Areas) and overall annual financial budget for flow cytometry (either
increasing or decreasing in % terms), over the next three years (see Future Budget Changes).
Figures and/or tables are also presented.
22.1 This chapter
22.2 Annual budgets
22.3 Costs per sample
22.4 Budget breakdown
22.5 Future budget
22.6 Discussion
Current Annual Financial Budgets
<$1 k
$1 - $2.5k
$2.5 - $5k
$5 - $10k
$10 - $25k
$25 - $50k
$50 - $100k
$100 - $250k
$250 - $500k
$500k - $1 million
$1 million - $2.5 million
$2.5 million - $5 million
>$5 m
12. +40%
+50%
>+50%
Increasing
23 Consumables
Investigated: Participants two main consumables in terms of costs, that are directly associated
with their use of flow cytometry. Figures and/or tables are also presented.
23.1 This Chapter
23.2 Consumables
23.3 Discussion
24 Quality Control
Investigated: Quality control systems or procedures adhered to in the use of flow cytometry.
Figures and/or tables are also presented.
24.1 This chapter
24.2 Quality control
24.3 Discussion
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