Author: Publisher: World Health Organization ISBN: 924003952X Category : Medical Languages : en Pages : 24
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: 9240094822 Category : Medical Languages : en Pages : 56
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: Ian Costello Publisher: Pharmaceutical Press ISBN: 9780853696865 Category : Medical Languages : en Pages : 148
Book Description
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 ISBN: 9240085173 Category : Business & Economics Languages : en Pages : 56
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
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: 9240068198 Category : Medical Languages : en Pages : 27
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: Suneja Publisher: Elsevier India ISBN: 9788131216729 Category : Languages : en Pages : 508
Book Description
The book provides comprehensive, up-to-date information about current guidelines for drug therapy in important diseases and emergencies in children; rational antimicrobial therapy; immunization and immunoprophylaxis. Besides others, the important topics covered include Blood Component Therapy and Antidotes for Common Poisoning . Separate sections deal with Drugs , Vaccines, Immunoglobulins and Antitoxins their indications, dosage, mode of use, precautions and other information. About the Author : - RK Suneja, former Head, Department of Pediatrics and Medical Superintendent, Hindu Rao Hospital is one of the leading pediatricians based at New Delhi, India.
Author: Hugo Juárez Olguín Publisher: ISBN: 9781536122633 Category : Drugs Languages : en Pages : 0
Book Description
Pediatrics is the form of medical care that is concerned with children from birth to adolescence, specializing in a variety of characteristics and changes subjective to each patient. Undoubtedly, these changes influence drug distribution and response. The body composition and the processes of biological and physiological maturation constitute important variables worthy of consideration in the effort to adequately satisfy the therapeutic necessities of all the age groups, since different formulations are required to achieve optimum therapy. The technological advances in the last decades have endowed humanity with the facilities to painstakingly analyze biological samples and thus give way to potential progress in pharmacokinetics and pharmacodynamics. From this knowledge, it becomes clear that the body is a dynamic model and thus, brings to light the necessity to individualize treatment regimens based on parameters of each and every individual, which in the past was not as important. There are instruments that contribute to optimizing drug management and safety in the pediatric population as recommended by the World Health Organization that rotate on the application of drug monitoring strategies that would contribute to ensuring the safety of patients and improve treatment schemes with increasingly safe and effective drugs. Furthermore, recourses to the therapeutic monitoring of drugs would become available where a monitoring based principally on the drug plasma levels is carried out in order to make the pertinent dose adjustments. The need for this will arise, since the most effective therapeutic range of many drugs is still unknown; unnecessarily high concentrations with potential risks of producing toxicity in patients is something that must be avoided. With these factors in mind, the decision to compose this book for pediatric doctors as well as specialists in the health sector who are dedicated to childcare became apparent, with the hope of portraying an array of pharmacokinetic knowledge, based on new therapeutic strategies ensuing from information furnished by research. The authors are convinced that the consideration of these concepts would definitely permit the elaboration of optimum and specific treatment for each pediatric patients.
Author: Conor D. Byrne Publisher: ISBN: 9781607415657 Category : Child Languages : en Pages : 0
Book Description
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.
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Author: World Health Organization
Author: World Health Organization
Author: Ian Costello
Author: World Health Organization
Author: World Health Organization
Author: World Health Organization
Author: Suneja
Author: Hugo Juárez Olguín
Author: Conor D. Byrne