Accelerating optimal approval of priority formulations for antibiotic use in children

Accelerating optimal approval of priority formulations for antibiotic use in children PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 924010335X
Category : Medical
Languages : en
Pages : 27

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Book Description
On 24 March 2023, WHO launched the first-ever list of priority paediatric formulations for antibiotics, addressing critical gaps in age-appropriate treatments for infants and children. This list, developed through WHO’s Paediatric Drug Optimization (PADO) process, identifies antibiotics urgently needing development to treat infections from high-priority pathogens. WHO, leveraging GAP-f and partners like GARDP and PENTA, led a technical consultation that concluded in March 2024 to review regulatory frameworks and streamline clinical research, aiming to accelerate regulatory approvals and ensure equitable access to effective treatments. The outcomes of this meeting are captured in this report, underscoring the collaborative efforts needed to advance essential paediatric formulations, minimize delays, and support globally aligned, evidence-based care for serious infections in children.

Accelerating optimal approval of priority formulations for antibiotic use in children

Accelerating optimal approval of priority formulations for antibiotic use in children PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 924010335X
Category : Medical
Languages : en
Pages : 27

Get Book Here

Book Description
On 24 March 2023, WHO launched the first-ever list of priority paediatric formulations for antibiotics, addressing critical gaps in age-appropriate treatments for infants and children. This list, developed through WHO’s Paediatric Drug Optimization (PADO) process, identifies antibiotics urgently needing development to treat infections from high-priority pathogens. WHO, leveraging GAP-f and partners like GARDP and PENTA, led a technical consultation that concluded in March 2024 to review regulatory frameworks and streamline clinical research, aiming to accelerate regulatory approvals and ensure equitable access to effective treatments. The outcomes of this meeting are captured in this report, underscoring the collaborative efforts needed to advance essential paediatric formulations, minimize delays, and support globally aligned, evidence-based care for serious infections in children.

Mechanisms of antibiotic resistance

Mechanisms of antibiotic resistance PDF Author: Jun Lin
Publisher: Frontiers Media SA
ISBN: 2889195260
Category : Antibiotics
Languages : en
Pages : 226

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Book Description
Antibiotics represent one of the most successful forms of therapy in medicine. But the efficiency of antibiotics is compromised by the growing number of antibiotic-resistant pathogens. Antibiotic resistance, which is implicated in elevated morbidity and mortality rates as well as in the increased treatment costs, is considered to be one of the major global public health threats (www.who.int/drugresistance/en/) and the magnitude of the problem recently prompted a number of international and national bodies to take actions to protect the public (http://ec.europa.eu/dgs/health_consumer/docs/road-map-amr_en.pdf: http://www.who.int/drugresistance/amr_global_action_plan/en/; http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf). Understanding the mechanisms by which bacteria successfully defend themselves against the antibiotic assault represent the main theme of this eBook published as a Research Topic in Frontiers in Microbiology, section of Antimicrobials, Resistance, and Chemotherapy. The articles in the eBook update the reader on various aspects and mechanisms of antibiotic resistance. A better understanding of these mechanisms should facilitate the development of means to potentiate the efficacy and increase the lifespan of antibiotics while minimizing the emergence of antibiotic resistance among pathogens.

Towards investigation, development and introduction of cefiderocol in children

Towards investigation, development and introduction of cefiderocol in children PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240084592
Category : Business & Economics
Languages : en
Pages : 8

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Book Description
In November-December 2022, WHO undertook a Paediatric Drug Optimization (PADO) exercise for antibiotics, to: identify antibiotics with an approved indication for children for which age-appropriate formulations are missing that need to be given priority for development (PADO priority list); and pipeline or approved antibiotics without an indication for children to be given priority for further investigation and development for children (PADO watch list). Cefiderocol was included in the PADO priority list considering its efficacy against multiple pathogens in the WHO Bacterial Priority Pathogens List, its favorable resistance and cross-resistance profile and considering that clinical trials involving children are ongoing. This information note aims to provide a summary of cefiderocol’s characteristics (regulatory approvals, current formulations, inclusion in the WHO EML etc), current and planned paediatric studies (including neonates) and initiatives to ensure prompt access for all people in need, as well as lay out interventions that should be prioritized by researchers and funders for cefiderocol development, as well as, more broadly for antibiotics that are much needed in children.

Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine

Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine PDF Author: National Academies Of Sciences Engineeri
Publisher: National Academies Press
ISBN: 9780309269452
Category : Medical
Languages : en
Pages :

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Book Description
The National Strategy for Combating Antibiotic Resistant Bacteria, published in 2014, sets out a plan for government work to mitigate the emergence and spread of resistant bacteria. Direction on the implementation of this strategy is provided in five-year national action plans, the first covering 2015 to 2020, and the second covering 2020 to 2025. Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine evaluates progress made against the national strategy. This report discusses ways to improve detection of resistant infections and estimate the risk to human health from environmental sources of resistance. In addition, the report considers the effect of agricultural practices on human and animal health and animal welfare and ways these practices could be improved, and advises on key drugs and diseases for which animal-specific test breakpoints are needed.

Priority Areas for National Action

Priority Areas for National Action PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309085438
Category : Medical
Languages : en
Pages : 160

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Book Description
A new release in the Quality Chasm Series, Priority Areas for National Action recommends a set of 20 priority areas that the U.S. Department of Health and Human Services and other groups in the public and private sectors should focus on to improve the quality of health care delivered to all Americans. The priority areas selected represent the entire spectrum of health care from preventive care to end of life care. They also touch on all age groups, health care settings and health care providers. Collective action in these areas could help transform the entire health care system. In addition, the report identifies criteria and delineates a process that DHHS may adopt to determine future priority areas.

WHO guideline on mass drug administration of azithromycin to children under five years of age to promote child survival

WHO guideline on mass drug administration of azithromycin to children under five years of age to promote child survival PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240009582
Category : Medical
Languages : en
Pages : 54

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Book Description
The purpose of the guideline was to provide an evidence-informed recommendation on whether mass drug administration of azithromycin, as a public health intervention for the reduction of under-five mortality, should (a) be rolled out universally in low- and middle-income countries, (b) be applied only in some situational contexts in low-and middle-income countries or (c) not be used at all.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations PDF Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1420048457
Category : Medical
Languages : en
Pages : 258

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Book Description
The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241

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Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Severe Community Acquired Pneumonia

Severe Community Acquired Pneumonia PDF Author: Jordi Rello
Publisher: Springer Science & Business Media
ISBN: 9780792373384
Category : Medical
Languages : en
Pages : 216

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Book Description
Severe Community Acquired Pneumonia is a book in which chapters are authored and the same topics discussed by North American and European experts. This approach provides a unique opportunity to view the different perspectives and points of view on this subject. Severe CAP is a common clinical problem encountered in the ICU setting. This book reviews topics concerning the pathogenesis, diagnosis and management of SCAP. The discussions on the role of alcohol in severe CAP and adjunctive therapies are important topics that further our understanding of this severe respiratory infection.

Guidelines on Core Components of Infection Prevention and Control Programmes at the National and Acute Health Care Facility Level

Guidelines on Core Components of Infection Prevention and Control Programmes at the National and Acute Health Care Facility Level PDF Author: World Health Organization
Publisher:
ISBN: 9789241549929
Category : Medical
Languages : en
Pages : 92

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Book Description
Health care-associated infections (HAI) are one of the most common adverse events in care delivery and a major public health problem with an impact on morbidity, mortality and quality of life. At any one time, up to 7% of patients in developed and 10% in developing countries will acquire at least one HAI. These infections also present a significant economic burden at the societal level. However, a large percentage are preventable through effective infection prevention and control (IPC) measures. These new guidelines on the core components of IPC programmes at the national and facility level will enhance the capacity of Member States to develop and implement effective technical and behaviour modifying interventions. They form a key part of WHO strategies to prevent current and future threats from infectious diseases such as Ebola, strengthen health service resilience, help combat antimicrobial resistance (AMR) and improve the overall quality of health care delivery. They are also intended to support countries in the development of their own national protocols for IPC and AMR action plans and to support health care facilities as they develop or strengthen their own approaches to IPC. These are the first international evidence-based guidelines on the core components of IPC programmes. These new WHO guidelines are applicable for any country and suitable to local adaptations, and take account of the strength of available scientific evidence, the cost and resource implications, and patient values and preferences.