This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field
application rates of new molluscicide products for control of schistosomiasis.
The protozoan parasite Trypanosoma cruzi causes Chagas disease, an important public health problem throughout Latin America. Current therapeutic options are characterised by limited efficacy, long treatment regimens and frequent toxic side-effects. Advances in this area have been compromised by gaps... in our knowledge of disease pathogenesis, parasite biology and drug activity. Nevertheless, several factors have come together to create a more optimistic scenario. Drug-based research has become more systematic, with increased collaborations between the academic and commercial sectors, often within the framework of not-for-profit consortia. High-throughput screening of compound libraries is being widely applied, and new technical advances are helping to streamline the drug development pipeline. In addition, drug repurposing and optimisation of current treatment regimens, informed by laboratory research, are providing a basis for new clinical trials. Here, we will provide an overview of the current status of Chagas disease drug development, highlight those areas where progress can be expected, and describe how fundamental research is helping to underpin the process.
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Evidence-based guidelines are one of the most useful tools for improving public health and clinical practice. Their purpose is to formulate interventions based on strong evidence of efficacy, avoid unnecessary risks, use resources efficiently, reduce clinical variability and, in essence, improve hea...lth and ensure quality care, which is the purpose of health systems and services. These guidelines were developed following the GRADE methodology, with the support of a panel of clinical experts from different countries, all convened by the Pan American Health Organization. By responding to twelve key questions about the clinical diagnosis and treatment of dengue, chikungunya, and Zika, evidence-based recommendations were formulated for pediatric, youth, adult, older adult, and pregnant patients who are exposed to these diseases or have a suspected or confirmed diagnosis of infection. The purpose of the guidelines is to prevent progression to severe forms of these diseases and the fatal events they may cause. The recommendations are intended for health professionals, including general, resident, and specialist physicians, nursing professionals, and medical and nursing students, who participate in caring for patients with suspected dengue, chikungunya, or Zika. They are also intended for health unit managers and the executive teams of national arboviral disease prevention and control programs, who are responsible for facilitating the process of implementing these guidelines.
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The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit...y areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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This technical report summarizes the discussions on the status of programmatic transition to tenofovir, lamivudine and dolutegravir (TLD) in low– and middle- income countries, addressing the best practices and major challenges faced by HIV programmes.
The latest data on safety and efficacy of do...lutegravir (DTG) containing regimens were also reviewed. The document identified the remaining gaps in knowledge, research, monitoring, and surveillance on DTG and TLD transition and listed the future priorities.
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There is strong demand for alternatives to pharmaceuticals for a variety of common illnesses due to concerns of safety, efficacy, and a desire for more “natural” products. Despite this growing interest, “conventional” healthcare providers may have little to no knowledge about herbal medicine...s, which is further compounded by the sometimes misleading information in the media and on the internet. This course provides the necessary background for providers to begin to incorporate herbal medicines into their practice, particularly in regards to their therapeutic properties, efficacy (or lack thereof), and safety concerns, including quality control and potential adverse effects
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Many countries are using the approach of mixing vaccine doses from different manufacturers. What do we know about the safety and efficacy of this approach? What does the evidence tell us about using a fraction of the vaccine dose ? Dr Katherine O’Brien explains in Science in 5 this week.
Closed C...aptioning is available for Science in 5 in several languages on YouTube:Spanish,Portuguese,Thai,Nepali,Maithili,BahasaandJapanese.
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Manufacturers:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) ir...respective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
The authors state that researchers, governments and global agencies should proceed with particular care in the evaluation of candidate SARS-CoV-2 vaccines in LMICs, with effective communication to build trust and avoid generation of vaccine hesitancy. Vaccine efficacy is often highly variable betwee...n high-resource and low-resource settings
Archives of Disease in Childhood, vol.106 Issue 2
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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verall strategy and objective of the European Antibiotic Awareness Day The overall objective of the European Antibiotic Awareness Day is to support national activities aimed at raising awareness concerning the proper use of antibiotics so as to maintain the efficacy of antibiotics and avoid the eme...rgence of resistant bacteria. To this aim, ECDC has decided to produce basic campaign communication materials that communicators in EU Member States can use in devising and implementing national campaigns. At the same time, a dedicated website will be launched in July 2008. These materials aim to provide a visual identity to the campaigns across the EU member states and make the messages more recognisable and consistent, thus memorable to the target audience. The choice of supporting visuals responds to the need of making the messages accessible to parents and young people, who represent the main target for the 2008 campaign.
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Essential Medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy, safety and comparative cost-effectiveness. This edition of the Essential Medicines List (EML) 2017 for Ghana has been deriv...ed from its companion Standard Treatment Guidelines 2017 to ensure harmony in treatment, procurement and re-imbursements. The medicines listed have been coded according to the Health Commodity
Codes Catalogue of the Ministry of Health (2008) and their levels of use, based on the type of health facility, including midwifery practice, have been indicated.
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Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly, such as an incorrect dose, insufficient duration or wrong frequency, resistance is heightened. The mi...suse of antimicrobials affects their efficacy, and increasingly more infections and diseases become untreatable. Many gains made in modern medicine throughout the 20th century will be lost, making AMR a global public and animal health issue that requires concerted action. AMR and the use of antimicrobials (AMU) affect food safety and security, people’s livelihoods, as well as economic and agricultural development.
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For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety and efficacy of “re-purposed” drugs that have been widely used to treat other infections but are al...so showing promise in the treatment of DR-TB, including linezolid and clofazimine. This special supplemental guide has been developed for nurses, because it is essential that nurses be provided with material that maximizes their ability to provide optimal support to patients who are receiving new and re-purposed drugs
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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L’ensemble du personnel de santé qui participe au déploiement et à la mise en œuvre de la vaccination contre la COVID-19 doit avoir les connaissances et les compétences requises pour garantir une administration sûre et efficace du vaccin contre la COVID-19. Ce cours de formation fournit des ...informations essentielles sur les vaccins contre la COVID-19, à l’aide de courtes vidéos didactiques, de documents explicatifs sur les vaccins, d’aide-mémoire, de sommaires thématiques et de présentations à télécharger.
Please note that further videos and resources concerning other vaccines will be added as they receive emergency use listing (EUL) or prequalification. Available in different languages
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Ce rapport attire l’attention des intervenants sur le fait que la langue est importante pour établir la confiance avec les personnes touchées par le virus Ebola et d’autres épidémies et pour une communication efficace avec ces dernières.