Pediatric Drug Development
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Pediatric Drug Development
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Author : Andrew E. Mulberg
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Pediatric Drug Development written by Andrew E. Mulberg and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Medical categories.
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.
Addressing The Barriers To Pediatric Drug Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2008-08-12
Addressing The Barriers To Pediatric Drug Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-08-12 with Medical categories.
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Pediatric Drug Development
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Author : Andrew E. Mulberg
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-20
Pediatric Drug Development written by Andrew E. Mulberg and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-20 with Medical categories.
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.
Pediatric Formulations
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Author : Daniel Bar-Shalom
language : en
Publisher: Springer Science & Business Media
Release Date : 2014-01-30
Pediatric Formulations written by Daniel Bar-Shalom and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-01-30 with Medical categories.
Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.
Safety Efforts In Pediatric Drug Development
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Author : Conor D. Byrne
language : en
Publisher:
Release Date : 2010
Safety Efforts In Pediatric Drug Development written by Conor D. Byrne and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Child categories.
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.
Fundamentals Of Pediatric Drug Dosing
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Author : Iftekhar Mahmood
language : en
Publisher: Springer
Release Date : 2016-10-28
Fundamentals Of Pediatric Drug Dosing written by Iftekhar Mahmood and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-28 with Medical categories.
Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not ‘small adults’, and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.
Considering The Patient In Pediatric Drug Development
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Author : Klaus Rose
language : en
Publisher: Academic Press
Release Date : 2020-11-19
Considering The Patient In Pediatric Drug Development written by Klaus Rose and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-19 with Business & Economics categories.
Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information
Essentials Of Translational Pediatric Drug Development
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Author : Elke Gasthuys
language : en
Publisher: Elsevier
Release Date : 2024-06-01
Essentials Of Translational Pediatric Drug Development written by Elke Gasthuys and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-06-01 with Medical categories.
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. Covers both theoretical and practical aspects of translational pediatric drug development Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) Offers best practices and future perspectives for the improvement of translational pediatric drug development
Guide To Paediatric Clinical Research
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Author : Klaus Rose
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2007
Guide To Paediatric Clinical Research written by Klaus Rose and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
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.
Pediatric Non Clinical Drug Testing
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Author : Alan M. Hoberman
language : en
Publisher: John Wiley & Sons
Release Date : 2011-12-28
Pediatric Non Clinical Drug Testing written by Alan M. Hoberman and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-28 with Medical categories.
This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.