General Considerations for the Clinical Evaluation of Drugs in Infants and Children PDF Download
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Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Chemotherapy
Languages : en
Pages : 28
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Book Description
Author: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
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Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Chemotherapy
Languages : en
Pages : 28
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Book Description
Author: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: United States. Food and Drug Administration. Division of Neuropharmacological Drug Products
Publisher:
ISBN:
Category : Infants
Languages : en
Pages : 167
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
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Book Description
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: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
Author: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Chemotherapy
Languages : en
Pages : 20
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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Book Description
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.
