Paediatric Drug Optimization Standard Procedure
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Paediatric Drug Optimization Standard Procedure
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-11-19
Paediatric Drug Optimization Standard Procedure written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-19 with Medical categories.
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.
Paediatric Drug Optimization For Antibiotics
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-03-22
Paediatric Drug Optimization For Antibiotics written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-22 with Medical categories.
Paediatric Drug Optimization For Tuberculosis
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-05-30
Paediatric Drug Optimization For Tuberculosis written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-30 with Medical categories.
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.
Paediatric Drug Optimization For Cancer Medicines
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-10-16
Paediatric Drug Optimization For Cancer Medicines written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-16 with Medical categories.
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.
Paediatric Drug Optimization For Neglected Tropical Diseases
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-21
Paediatric Drug Optimization For Neglected Tropical Diseases written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-21 with Business & Economics categories.
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.
Report Of The Paediatric Regulatory Network Meeting 12 13 May 2022
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-04-19
Report Of The Paediatric Regulatory Network Meeting 12 13 May 2022 written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-19 with Business & Economics categories.
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.
Paediatric Drug Optimization For Covid 19
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-03-23
Paediatric Drug Optimization For Covid 19 written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-23 with Medical categories.
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.
Accelerating Research Development And Access To Paediatric Medicines
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-11-13
Accelerating Research Development And Access To Paediatric Medicines written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-13 with Medical categories.
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.
Accelerating Optimal Approval Of Priority Formulations For Antibiotic Use In Children
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-11-20
Accelerating Optimal Approval Of Priority Formulations For Antibiotic Use In Children written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-20 with Medical categories.
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 The Development Of Priority Formulations For Antibiotic Use In Children
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2025-03-04
Accelerating The Development Of Priority Formulations For Antibiotic Use In Children written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-03-04 with Medical categories.
This document summarizes proceedings and outcomes of a technical consultation designed to develop target product profiles for three priority antibiotics for children, azithromycin, amoxicillin clavulanic acid and nitrofurantoin, that took place on 7–9 May 2024 and was followed up with a closing virtual session on 1 October 2024. Target product profiles for azithromycin and nitrofurantoin were developed as a result and are now being promoted for development and manufacturing of age-appropriate formulations.