Download or read book Paediatric drug optimization standard procedure written by and published by World Health Organization. This book was released on 2021-11-19 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Paediatric drug optimization for antibiotics written by World Health Organization and published by World Health Organization. This book was released on 2023-03-22 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Paediatric drug optimization for tuberculosis written by World Health Organization and published by World Health Organization. This book was released on 2024-05-30 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Paediatric drug optimization for neglected tropical diseases written by World Health Organization and published by World Health Organization. This book was released on 2023-11-21 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Paediatric drug optimization for COVID 19 written by World Health Organization and published by World Health Organization. This book was released on 2023-03-23 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Report of the Paediatric Regulatory Network meeting 12 13 May 2022 written by World Health Organization and published by World Health Organization. This book was released on 2024-04-19 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Paediatric Drug Handling written by Ian Costello and published by Pharmaceutical Press. This book was released on 2007 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of all of the issues pharmacists serving pediatric patients must consider. Chapters relating to pharmacogenomics, medication error prevention, compounding, and government regulations are extremely informative.
Download or read book Shaping the global innovation and access landscape for better paediatric medicines written by World Health Organization and published by World Health Organization. This book was released on 2022-08-26 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safety Efforts in Pediatric Drug Development written by Conor D. Byrne and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the safety efforts being implemented in paediatric drug development. Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only about one-third of the drugs that are prescribed for children have been studied and labelled for paediatric use. This has placed children taking drugs for which there have not been adequate paediatric drug studies at risk of being exposed to ineffective treatment or receiving incorrect dosing. In order to encourage the study of more drugs for paediatric use, Congress passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to provide marketing incentives to drug manufacturers for conducting paediatric drug studies. Drug manufacturers may obtain six months of additional market exclusivity for drugs on which they have conducted paediatric studies in accordance with pertinent law and regulations. This book also evaluates the impact of BPCA on labelling drugs for paediatric use and the process by which the labelling was changed, and illustrates the range of diseases treated by the drugs studied under BPCA. Additionally this book provides guidance on the role and timing of animal studies in the non-clinical safety evaluation of therapeutics intended for the treatment of paediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in paediatric patients and makes recommendations on non-clinical testing. This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access.
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 843 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.
Download or read book Guide to Paediatric Clinical Research written by Klaus Rose and published by Karger Medical and Scientific Publishers. This book was released on 2007 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.
Download or read book Report of the meeting to review the paediatric antituberculosis drug optimization priority list written by and published by World Health Organization. This book was released on 2021-03-25 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Paediatric Antituberculosis Drug Optimization (PADO-TB) meetings provide a forum for clinicians, researchers, financial and technical partners and other relevant key stakeholders to work together, to ensure that priority optimal paediatric formulations of TB medicines are investigated, developed and made available to children in a timely manner. After the first meeting (PADO-TB1) in February 2019, WHO hosted an interim review of the PADO-TB1 priorities. The review considered the latest WHO recommendations and other relevant developments since February 2019, such as results of clinical trials, results of pharmacokinetics and pharmacodynamics studies, new formulations available and advancements of key drugs in the TB research and development pipeline. The 4.5-hour virtual review was attended by more than 50 experts including clinicians, researchers, representatives of national TB programmes (NTPs) from high TB burden countries, community representatives, financial and technical partners, members of the Child and Adolescent TB Working Group and representatives from various international agencies, including WHO. This report summarizes the main developments presented for various TB medicines and the decisions taken with regard to the PADO-TB priority list.
Download or read book Initiation task force meeting for the Paediatric Regulatory Network written by and published by World Health Organization. This book was released on 2022-05-30 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Global report on neglected tropical diseases 2024 written by World Health Organization and published by World Health Organization. This book was released on 2024-05-04 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document is the second in a series of global reports describing progress towards the 2030 targets set in Ending the neglect to attain the Sustainable Development Goals: a road map for neglected tropical diseases 2021–2030. It describes a wide range of activities, accomplishments and challenges across the portfolio of NTDs and across all six WHO regions. The report presents epidemiological and programmatic data for 2022, which were gathered, compiled and analysed in 2023. In some cases, 2023 data are available and presented; in other cases, less recent information is included, when 2022 data are not available. In addition, it presents the main facts or events that occurred in 2023. In line with the road map’s companion document Ending the neglect to attain the Sustainable Development Goals: a framework for monitoring and evaluating progress of the road map for neglected tropical diseases 2021−2030, the report includes quantitative information on the status of the overarching, cross-cutting and disease-specific indicators. This is followed by qualitative information on each of the three road map pillars and on regional and country progress. The conclusions of the report and way forward are further complemented by annexes on cross-cutting indicator 6, status of donated medicines for treatment of NTDs, articles on NTDs published in the Weekly Epidemiological Record, target product profiles published as of 31 December 2023 and the list of global NTD reports published by WHO so far.
Download or read book Programme budget 2022 2023 written by and published by World Health Organization. This book was released on 2021-10-08 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
Download or read book Pediatric Nuclear Medicine written by Leonard M. Freeman and published by . This book was released on 1975 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
