Paediatric Medicines

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publisher : National Academies Press
Page : 432 pages
File Size : 55,7 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

Get Book

Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Author : Great Britain: Parliament: House of Lords: European Union Committee
Publisher : The Stationery Office
Page : 132 pages
File Size : 51,6 Mb
Release : 2006-02-02
Category : Medical
ISBN : 0104008091

Get Book

Paediatric Medicines by Great Britain: Parliament: House of Lords: European Union Committee Pdf

Over 50 per cent of all medicines given to children (and about 90 per cent of those given to the newly-born) have never been tested or authorised for use on them. The Committee's report examines the European Commission's proposal to introduce a Regulation (the Clinical Trials Directive) on medicinal products for paediatric use which aims to stimulate the development of medicines for children and lay down rules for testing and approval. Issues discussed include: the need for better regulation of paediatric medicines; the ethical considerations involved in clinical trials on children, including the issue of consent; mechanisms for implementing the Regulation; access to the database of information on clinical trials; the rewards and incentives proposed to stimulate the research and development of medicines; and the legal basis for the regulation under the EC Treaty. The Committee's report recognises the urgent need for effective action at the European level to authorise medicines for paediatric use and gives broad support to the proposed Directive. However, a number of key issues are highlighted, including: the need for improved labelling of medicines; that the guidelines underpinning the Directive should take account of ethical considerations involved to ensure the rights and capacity of children to give informed consent to trials; and concerns are raised about the adequacy of proposed incentive mechanisms.

Author : Ian Costello
Publisher : Pharmaceutical Press
Page : 148 pages
File Size : 50,8 Mb
Release : 2007
Category : Medical
ISBN : 0853696861

Get Book

Paediatric Drug Handling by Ian Costello Pdf

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 : 65 pages
File Size : 42,8 Mb
Release : 2007
Category : Medical
ISBN : 9789241563437

Get Book

Promoting Safety of Medicines for Children by World Health Organization Pdf

Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.

Author : Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher : Council of CanadianAcademies
Page : 266 pages
File Size : 51,9 Mb
Release : 2014-09
Category : Drugs
ISBN : 9781926558851

Get Book

Improving Medicines for Children in Canada by Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth Pdf

Author : Anonim
Publisher : World Health Organization
Page : 73 pages
File Size : 45,9 Mb
Release : 2021-11-10
Category : Medical
ISBN : 9789240008182

Get Book

Innovative delivery systems for paediatric medicines by Anonim Pdf

Author : Evelyne Jacqz-Aigrain,Imti Choonara
Publisher : CRC Press
Page : 830 pages
File Size : 43,9 Mb
Release : 2021-02-25
Category : Medical
ISBN : 9780849374449

Get Book

Paediatric Clinical Pharmacology by Evelyne Jacqz-Aigrain,Imti Choonara Pdf

The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.

Author : World Health Organization
Publisher : World Health Organization
Page : 48 pages
File Size : 40,7 Mb
Release : 2022-03-25
Category : Medical
ISBN : 9789240044647

Get Book

Shaping the global innovation and access landscape for better paediatric medicines by World Health Organization Pdf

GAP-f’s three-year strategic plan (2022-2024) builds from the work undertaken to date by the network of leading partners, both individually and collectively, through GAP-f. With this strategy, GAP-f is excited to increase its footprint into a broader set of diseases to bring it closer to its vision of all children having equitable access to the medicines they need.

Author : Klaus Rose,John N. Van den Anker
Publisher : Karger Medical and Scientific Publishers
Page : 240 pages
File Size : 48,6 Mb
Release : 2010-01-01
Category : Medical
ISBN : 9783805593625

Get Book

Guide to Paediatric Drug Development and Clinical Research by Klaus Rose,John N. Van den Anker Pdf

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 54,6 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

Get Book

Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Author : World Health Organization
Publisher : World Health Organization
Page : 442 pages
File Size : 43,5 Mb
Release : 2013
Category : Medical
ISBN : 9789241548373

Get Book

Pocket Book of Hospital Care for Children by World Health Organization Pdf

The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.

Author : Daniel Bar-Shalom,Klaus Rose
Publisher : Springer Science & Business Media
Page : 429 pages
File Size : 51,7 Mb
Release : 2014-01-30
Category : Medical
ISBN : 9781489980113

Get Book

Pediatric Formulations by Daniel Bar-Shalom,Klaus Rose Pdf

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.

Author : Hannsjörg W. Seyberth,Anders Rane,Matthias Schwab
Publisher : Springer Science & Business Media
Page : 385 pages
File Size : 42,6 Mb
Release : 2011-09-01
Category : Medical
ISBN : 9783642201950

Get Book

Pediatric Clinical Pharmacology by Hannsjörg W. Seyberth,Anders Rane,Matthias Schwab Pdf

The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy.

Author : Klaus Rose,John N. Van den Anker
Publisher : Karger Medical and Scientific Publishers
Page : 164 pages
File Size : 49,6 Mb
Release : 2007
Category : Medical
ISBN : 9783805582018

Get Book

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 : K. Rose,J.N. van den Anker
Publisher : Karger Medical and Scientific Publishers
Page : 242 pages
File Size : 52,6 Mb
Release : 2010-05-21
Category : Medical
ISBN : 9783805593632

Get Book

Guide to Paediatric Drug Development and Clinical Research by K. Rose,J.N. van den Anker Pdf

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.