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Paediatric drug optimization standard procedure by Anonim Pdf
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 Page : 27 pages File Size : 55,7 Mb Release : 2023-03-22 Category : Medical ISBN : 9789240068933
Author : World Health Organization Publisher : World Health Organization Page : 56 pages File Size : 47,5 Mb Release : 2024-05-30 Category : Medical ISBN : 9789240094826
Paediatric drug optimization for tuberculosis by World Health Organization Pdf
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 Page : 56 pages File Size : 45,9 Mb Release : 2023-11-21 Category : Business & Economics ISBN : 9789240085176
Paediatric drug optimization for neglected tropical diseases by World Health Organization Pdf
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 Page : 27 pages File Size : 48,6 Mb Release : 2023-03-23 Category : Medical ISBN : 9789240068193
Paediatric drug optimization for COVID-19 by World Health Organization Pdf
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.
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.
Author : World Health Organization Publisher : World Health Organization Page : 31 pages File Size : 46,6 Mb Release : 2024-04-19 Category : Business & Economics ISBN : 9789240091276
Report of the Paediatric Regulatory Network meeting, 12-13 May 2022 by World Health Organization Pdf
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 Page : 56 pages File Size : 50,6 Mb Release : 2022-08-26 Category : Medical ISBN : 9789240056909
Safety Efforts in Pediatric Drug Development by Conor D. Byrne Pdf
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.
Author : Klaus Rose,John N. Van den Anker Publisher : Karger Medical and Scientific Publishers Page : 164 pages File Size : 55,8 Mb Release : 2007 Category : Medical ISBN : 9783805582018
Guide to Paediatric Clinical Research by Klaus Rose,John N. Van den Anker Pdf
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.
Author : World Health Organization Publisher : World Health Organization Page : 86 pages File Size : 49,6 Mb Release : 2024-05-04 Category : Medical ISBN : 9789240091535
Global report on neglected tropical diseases 2024 by World Health Organization Pdf
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.
Yaffe and Aranda's Neonatal and Pediatric Pharmacology by Jacob V. Aranda Pdf
The premier comprehensive textbook in the field, Yaffe and Aranda’s Neonatal and Pediatric Pharmacology, Fifth Edition, provides an authoritative overview of all aspects of drug therapy in newborns, children, and adolescents. It offers evidence-based guidelines for safe, effective, and rational drug therapy, including specific recommendations for all major drug classes and diseases. Now in a vibrant two-color format, this fully revised reference is an indispensable resource for pediatricians, neonatologists, pediatric residents, and fellows in different pediatric subspecialties, including neonatal medicine and pediatric critical care.
Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
Author : Andrew E. Mulberg,Steven A. Silber,John N. van den Anker Publisher : John Wiley & Sons Page : 843 pages File Size : 47,7 Mb Release : 2011-09-20 Category : Medical ISBN : 9781118210437
Pediatric Drug Development by Andrew E. Mulberg,Steven A. Silber,John N. van den Anker Pdf
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.