Product Profile

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Product Profile

Author : Anonim
Publisher : Unknown
Page : 70 pages
File Size : 44,7 Mb
Release : 1992
Category : United States
ISBN : STANFORD:36105131566049

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Product Profile by Anonim Pdf

Target product profile for HIV drug resistance tests in low- and middle-income countries: Africa

Author : World Health Organization
Publisher : World Health Organization
Page : 30 pages
File Size : 41,6 Mb
Release : 2023-09-12
Category : Medical
ISBN : 9789240076662

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Target product profile for HIV drug resistance tests in low- and middle-income countries: Africa by World Health Organization Pdf

HIV-1 drug resistance tests may be useful tools for optimizing ART regimens when used in the context of information about viral load, immune and clinical status, adherence practices and available treatment options. Several types of drug resistance tests are available, either as commercial kits or based on published methods for in-house assays. The target product profile for HIV drug resistance tests in low- and middle-income countries: Africa is designed to guide the development of new HIV drug resistance tests in the era of dolutegravir-based antiretroviral therapy (ART) and to facilitate the evaluation of the suitability of currently available HIV drug resistance tests for specific applications. The target product profiles focus on the new-term future for available ART regimens and their use and anticipates an innovate test that will meet the projected demand.

Target product profile for readers of rapid diagnostic tests

Author : World Health Organization
Publisher : World Health Organization
Page : 26 pages
File Size : 46,6 Mb
Release : 2023-01-31
Category : Medical
ISBN : 9789240067172

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Target product profile for readers of rapid diagnostic tests by World Health Organization Pdf

Target product profile for drugs to manage preterm labour

Author : World Health Organization
Publisher : World Health Organization
Page : 20 pages
File Size : 46,9 Mb
Release : 2023-12-04
Category : Medical
ISBN : 9789240081253

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Target product profile for drugs to manage preterm labour by World Health Organization Pdf

Preterm birth (i.e. birth before 37 completed weeks of gestation) is the leading cause of neonatal mortality globally. Preterm newborns that survive are at an increased risk of a number of short- and long-term adverse health outcomes, including chronic lung disease, infections and neurological, visual and auditory disabilities. A number of tocolytic agents are currently in use internationally to slow down or stop the progression of labour. However, none of those has shown substantive improvements in fetal or newborn health outcomes.There is an urgent need for new agents to manage preterm birth, thereby reducing adverse outcomes for newborns. An initial target product profile (TPP) for drugs to manage preterm labour was developed and published by external parties. Following the identification of an unmet public health need, WHO has considered the already published TPP as the basis for developing a WHO TPP. The purpose of this TPP is to guide product developers and funders on the key characteristics and desired attributes of therapeutic agents for pregnant women experiencing spontaneous preterm labour.

Target product profile for drugs to prevent pre-eclampsia

Author : World Health Organization
Publisher : World Health Organization
Page : 20 pages
File Size : 41,8 Mb
Release : 2023-11-23
Category : Medical
ISBN : 9789240081130

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Target product profile for drugs to prevent pre-eclampsia by World Health Organization Pdf

TPP for drugs to prevent pre-eclampsia Pre-eclampsia and eclampsia affect 4.6% and 1.4% of pregnant women, respectively. They account for the majority of maternal deaths and stillbirths due to hypertensive disorders of pregnancy. Pre-eclampsia can also negatively affect fetal growth, and increase the risk of preterm birth and fetal death. There is an urgent need to identify new agents to prevent pre-eclampsia. An initial target product profile (TPP) for drugs to prevent pre-eclampsia was developed and published by external parties. Following the identification of an unmet public health need, WHO has considered the already published TPP as the basis for developing a WHO TPP. This WHO TPP describes the key characteristics and desired attributes of preventive agents that should be administered to pregnant women identified as being at increased risk of developing pre-eclampsia, accompanied by monitoring for the development of pre-eclampsia. This TPP outlines minimal and preferred characteristics of a medicine that should: - prevent the development of pre- eclampsia; - have a good safety profile during pregnancy; - be commenced early in pregnancy (before 20 weeks’ gestation) and continued throughout pregnancy and postpartum as required; - be suitable for administration in any health care setting where pregnant women receive antenatal care, including in LMICs.

Target product profile for drugs to treat pre-eclampsia

Author : World Health Organization
Publisher : World Health Organization
Page : 24 pages
File Size : 48,5 Mb
Release : 2023-11-23
Category : Medical
ISBN : 9789240081154

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Target product profile for drugs to treat pre-eclampsia by World Health Organization Pdf

Target product profile for drugs to prevent spontaneous preterm birth

Author : World Health Organization
Publisher : World Health Organization
Page : 20 pages
File Size : 44,9 Mb
Release : 2023-12-04
Category : Medical
ISBN : 9789240081239

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Target product profile for drugs to prevent spontaneous preterm birth by World Health Organization Pdf

Preterm birth (i.e. birth before 37 completed weeks of gestation) is the leading cause of neonatal mortality globally. There is an urgent need for new agents to prevent preterm birth, thereby reducing adverse outcomes for newborns. An initial target product profile (TPP) for drugs to prevent spontaneous preterm birth was developed and published by external parties. Following the identification of an unmet public health need, WHO has considered the already published TPP as the basis for developing a WHO TPP. The purpose of this TPP is to guide product developers and funders on the key characteristics and desired attributes of preventive agents that should be administered to pregnant women at increased risk of spontaneous preterm birth. This TPP outlines the minimal and preferred characteristics of a medicine that should: - reduce the likelihood of preterm birth and thus prevent (or mitigate) adverse newborn outcomes due to prematurity; - have an excellent safety profile during pregnancy; - be suitable for prescription or administration by skilled health personnel in any health care setting where pregnant women receive antenatal care, including in LMICs; - be commenced early in pregnancy and can be continued throughout pregnancy, as required.

Measles-rubella microarray patch (MR–MAP) target product profile

Author : World Health Organization,United Nations Children's Fund
Publisher : World Health Organization
Page : 24 pages
File Size : 48,5 Mb
Release : 2020-03-06
Category : Medical
ISBN : 9789240000209

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Measles-rubella microarray patch (MR–MAP) target product profile by World Health Organization,United Nations Children's Fund Pdf

Target product profile to detect prepatent Dracunculus medinensis infections in animals

Author : World Health Organization
Publisher : World Health Organization
Page : 21 pages
File Size : 54,6 Mb
Release : 2024-04-03
Category : Medical
ISBN : 9789240090804

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Target product profile to detect prepatent Dracunculus medinensis infections in animals by World Health Organization Pdf

Dracunculiasis, also known as Guinea-worm disease, is caused by infection with the parasitic nematode Dracunculus medinensis (the Guinea worm). In May 1986, the Thirty-ninth World Health Assembly declared global elimination (i.e. eradication) of dracunculiasis as a goal. The global dracunculiasis eradication campaign, through community-based interventions, has reduced the burden of the disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases and 688 animal infections during 2022. To date, however, there are no validated tests to diagnose pre-patent D. medinensis infection. A critical part of any eradication programme involves reliably identifying infected and exposed definitive hosts. Historically, the diagnosis of Guinea-worm disease was clinical in nature and occurred via visually confirming the emergence of a white worm, roughly 10–14 months after the acquisition of infection. Currently, the definitive diagnosis involves either microscopy or, if necessary, conventional polymerase chain reaction applied to a DNA preparation from emergent worm fragments. A diagnostic tool capable of confirming active infection with D. medinensis many months before the emergence of a Guinea worm would represent a leap forward for the global dracunculiasis eradication campaign. Diagnostic modalities and platforms that can be easily used in locations where Guinea worm is observed or suspected among animal hosts are needed for the early diagnosis of prepatent Guinea worm infection to enhance follow-up and containment of infected hosts. Through the early detection and containment of Guinea worm-infected hosts, these diagnostics would ultimately serve to decrease the amount of parasite available in the environment for onward transmission. Diagnostic tools capable of detecting prepatent infection would enhance disease surveillance and provide national programme staff with additional data to identify transmission hot spots before the emergence of worms in affected areas. Diagnostic tools that can identify hosts with prepatent infection would further inform the targeting and implementation of disease-preventive interventions such as tethering of domesticated animal hosts and treating surface water sources with larvicide. Guinea worm diagnostic tools that could detect prepatent infection would also generate evidence of the absence of Guinea worm infection in definitive hosts, which could help certify countries as free of dracunculiasis transmission and ultimately facilitate the certification of dracunculiasis eradication.

Target product profile to detect Dracunculus medinensis presence in environmental samples

Author : World Health Organization
Publisher : World Health Organization
Page : 22 pages
File Size : 43,6 Mb
Release : 2024-04-03
Category : Medical
ISBN : 9789240090781

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Target product profile to detect Dracunculus medinensis presence in environmental samples by World Health Organization Pdf

Dracunculiasis, also known as Guinea-worm disease, is caused by infection with the parasitic nematode (the Guinea worm). In May 1986, the Thirty-ninth World Health Assembly declared global elimination (i.e. eradication) of dracunculiasis as a goal. The global dracunculiasis eradication campaign, through community-based interventions, has reduced the burden of the disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases and 688 animal infections during 2022. To date, however, there are no field-validated tests to detect the presence of D. medinensis-specific analytes in the environment. Although the scale of the surveillance infrastructure in countries endemic for Guinea-worm disease is impressive, initiating active surveillance and implementing disease-preventive interventions in any given area is triggered only when a host with an emergent worm is detected in that area or a nearby area. Unlike polio eradication, where an environmental diagnostic tool exists, there is no such tool for dracunculiasis eradication. Diagnostic tools that can detect evidence of analytes specific to D. medinensis in environmental samples can be used to identify geographies that are at risk for transmission of D. medinensis. Results from such environmental tools can complement surveillance data generated via active, community-based case and infection searches for subcutaneous and emergent Guinea worms and proactive or passive reporting of Guinea-worm disease. As such, environmental surveillance tools could augment current surveillance activities and enhance surveillance in a manner unprecedented for the global dracunculiasis eradication campaign. Viable environmental assays that can detect evidence of analytes (nucleic acid or other antigens) specific to D. medinensis in various environmental samples from water, aquatic animals, and perhaps aquatic animal waste, could be used to guide the targeting and implementation of disease-preventive interventions in endemic areas. For example, such tools could further inform which surface water sources should be treated with larvicide. Environmental surveillance tools could also generate additional data to inform decision-making about when and where to contract or expand active, community-based surveillance and implement other programmatic interventions. Environmental surveillance tools would be useful for generating additional surveillance data in areas with known or suspected wildlife transmission. Diagnostic tools capable of detecting D. medinensis-specific analytes in environmental samples would also generate data on the absence of Guinea worm in the environment, which could help certify countries as free of dracunculiasis transmission, ultimately facilitate the certification of dracunculiasis eradication, and support post-certification efforts.

Target product profile for next-generation drug-susceptibility testing at peripheral centres

Author : Anonim
Publisher : World Health Organization
Page : 52 pages
File Size : 47,6 Mb
Release : 2021-08-09
Category : Medical
ISBN : 9789240032361

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Target product profile for next-generation drug-susceptibility testing at peripheral centres by Anonim Pdf

The first high-priority Target Product Profile (TPPs) for new tuberculosis diagnostics were launched in April 2014. Following advances in the TB diagnostics and treatment pipelines since the release of these TPPs as well as recent updates to WHO TB treatment and diagnostics guidelines, a revision process of this TPP was initiated. The objective of the revision was to steer the R&D pipeline discussions to address current diagnostic gaps, seeking alignment with and patient and population needs.