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Author:
Publisher: World Health Organization
ISBN: 924003952X
Category : Medical
Languages : en
Pages : 24
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Book Description
The aim of this document is to provide guidance on how to undertake a paediatric drug optimization (PADO) exercise and identify key priority products for research and development. This guidance is for all technical units undertaking a PADO exercise, all stakeholders involved in PADO processes as well as interested organizations and experts involved in the research and development of therapeutics in the public and private sectors.
Author:
Publisher: World Health Organization
ISBN: 924003952X
Category : Medical
Languages : en
Pages : 24
Get Book Here
Book Description
The aim of this document is to provide guidance on how to undertake a paediatric drug optimization (PADO) exercise and identify key priority products for research and development. This guidance is for all technical units undertaking a PADO exercise, all stakeholders involved in PADO processes as well as interested organizations and experts involved in the research and development of therapeutics in the public and private sectors.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240068937
Category : Medical
Languages : en
Pages : 27
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Book Description
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240094822
Category : Medical
Languages : en
Pages : 56
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Book Description
Paediatric drug optimization (PADO) exercises have been convened by the World Health Organization (WHO) for various diseases, demonstrating their potential and impact to accelerate access to optimal formulations in the context of fragmented small markets for medicines for children. The WHO Global Tuberculosis Programme has convened PADO-TB meetings since February 2019 (PADO-TB1), followed by an interim review of the PADO-TB1 priorities in September 2020. Optimization of paediatric TB medicines forms part of the key actions in the Roadmap towards ending TB in children and adolescents, third edition and contributes to the achievement of the targets for ending TB in children and adolescents set out at the second United Nations High-level Meeting on the Fight Against TB in 2023. Considering the latest WHO recommendations on drug-susceptible TB, drug-resistant TB and TB preventive treatment, recent developments in new TB medicines and formulations made available, results of clinical trials and studies, and advancements of key medicines in the TB R&D pipeline, WHO convened the second PADO-TB meeting (PADO-TB2) on 3–5 October 2023. This meeting report summarizes the proceedings, discussions and the main consensus-based outputs of the PADO-TB2 meeting: - PADO-TB2 priority list (priority formulations to be investigated/developed in the short term and essential formulations to be developed in the longer term) - PADO-TB2 watch list (promising candidates for investigation/development for children within 5–10 years) - Priority research questions.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240101055
Category : Medical
Languages : en
Pages : 33
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Book Description
The goal of the Paediatric drug optimization for cancer exercise was to develop a PADO priority list of formulations to be prioritized with a time horizon of 3–5 years, and a PADO ‘watch list’ containing promising candidates for investigation and development for children with a time horizon of 5–10 years. The PADO–cancer exercise enables alignment between funders, procurers, market-coordination entities, researchers, innovators, generics manufacturers, product development partnerships and regulators on priority products to be investigated and developed, as well as increasing efforts to tackle challenges in access to cancer medicines in LMICs.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240085173
Category : Business & Economics
Languages : en
Pages : 56
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Book Description
Priority-setting is the first step to enable a targeted approach to research and development. Developing a prioritized drug portfolio of the most needed formulations for children is essential to streamline researchers’ and supplier’s efforts and resources around specific dosage forms and formulations that address most urgent needs for children. In general, due to limited financial incentives, few new drugs are being developed for Neglected Tropical Diseases (NTDs). Several NTDs disproportionately affect children compared to adults and, as is the case like for most diseases affecting adults and children, the burden to children is compounded by lack of inclusion of paediatric populations in clinical trials and/or lack of age-appropriate dosing regimens and formulations. The PADO-NTD exercise concluded with a final meeting organized in September 2023 with representatives from the four prioritized disease areas to reach consensus on a final PADO-NTD priority list, watch list and research questions and discuss transversal issues for the way forward. The meeting report will include summaries of the background, discussions and deliberations of all PADO exercises, and final conclusions and outputs of the overall PADO for NTD exercises.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240091270
Category : Business & Economics
Languages : en
Pages : 31
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Book Description
The Paediatric Regulatory Network was initially created as a global paediatric working group in February 2010 in response to a recommendation from the 2008 International Conference on Drug Regulatory Authorities and as part of the World Health Organization (WHO) Better Medicines for Children Project in collaboration with the Bill & Melinda Gates Foundation, to offer a platform for discussion on paediatric regulatory considerations for national regulatory authorities. The Network was reactivated in December 2019 as a global paediatric network supporting the availability of quality-assured medical products for children, by facilitating communication, collaboration, training and regulatory harmonization across the development, registration and pharmacovigilance of paediatric medical products. The Network’s activities contribute efficiently to the implementation of World Health Assembly resolutions WHA60.20 (2007) on better medicines for children, WHA69.20 (2016) on promoting innovation and access to quality, safe, efficacious and affordable medicines for children, WHA67.20 (2014) on regulatory system strengthening for medical products and WHA67.22 (2014) on access to essential medicines.
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240068198
Category : Medical
Languages : en
Pages : 27
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Book Description
This meeting report summarizes the prioritization exercise for COVID-19 medications using the Paediatric Drug Optimization (PADO) process to identify research gaps and accelerate formulations under the umbrella of the Global Accelerator for Paediatric formulations (GAP-f). The target audience are policy makers, academic institutions, and NGOs.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240102345
Category : Medical
Languages : en
Pages : 25
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Book Description
The GAP-f Phase 2 Progress Report highlights the network’s achievements and milestones from 2022 to 2024, providing a transparent overview of its impact. The report offers open, transparent, and comprehensive accountability to GAP-f’s partners, supporters, and beneficiaries, highlighting the impact of collaborative initiatives. By showcasing progress, pinpointing areas for continued focus, and sharing insights gained, the report serves as a vital tool for sustaining trust and engagement with stakeholders and guiding the planning and focus of GAP-f’s next strategic phase.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240101136
Category : Medical
Languages : en
Pages : 13
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Book Description
Neglected tropical diseases (NTDs) are a diverse set of 21 diseases and disease groups that mainly affect resource-poor populations in tropical and subtropical countries. In general, due to limited financial incentives, few new drugs are being developed for NTDs. This Technical Brief provides succinct information on the current R&D situation in terms of treatments for NTDs in children and existing gaps, with a view to addressing these gaps and supporting the research agenda setting.
