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Author: Daniel Bar-Shalom
Publisher: Springer Science & Business Media
ISBN: 1489980113
Category : Medical
Languages : en
Pages : 429
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Book Description
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: Daniel Bar-Shalom
Publisher: Springer Science & Business Media
ISBN: 1489980113
Category : Medical
Languages : en
Pages : 429
Get Book
Book Description
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: Milap Nahata
Publisher:
ISBN: 9780929375144
Category : Medical
Languages : en
Pages :
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Book Description
Author: Nunzio Denora
Publisher: MDPI
ISBN: 303650740X
Category : Science
Languages : en
Pages : 205
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Book Description
The development of paediatric medicines can be challenging since this is a different patient population with specific needs. A medicine designed for use in paediatric patients must consider the following aspects: patient population variability; the need for dose flexibility; route of administration; patient compliance; excipient tolerability. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Globally, about 75% of drugs do not carry regulatory approval for use in children; worldwide, many medications prescribed for the treatment of paediatric diseases are used off-label, and less than 20% of package inserts have sufficient information for treating children. This book provides an update on both state-of-the-art methodology and operational challenges in paediatric formulation design and development. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients.
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782
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Book Description
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.
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: Rita K. Jew
Publisher:
ISBN: 9781585286515
Category : Children
Languages : en
Pages : 0
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Book Description
Now even more comprehensive, this fourth edition of Extemporaneous Formulations provides the same evidence-based formulation in easy-to-follow 'recipes' for 312 formulations, 129 of which are new.
Author: Milap C. Nahata
Publisher:
ISBN: 9780929375007
Category : Medicine
Languages : en
Pages : 81
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Book Description
Author:
Publisher:
ISBN: 9780929375120
Category :
Languages : en
Pages :
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Book Description
Author: Rita K. Jew
Publisher: ASHP
ISBN: 1585285269
Category : Medical
Languages : en
Pages : 224
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Book Description
This reference has served an important and continuing need for evidence–based “recipes” in extemporaneous formulations. It is the go-to resource for pharmacists treating patients who require any of the 80% of medications that are not commercially available in appropriate forms or dosages for pediatric, geriatric, or other special populations. The third edition will include 39 new formulations.
Author: Katharina Manassis
Publisher: Guilford Publications
ISBN: 1462515606
Category : Psychology
Languages : en
Pages : 257
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Book Description
Highly practical and accessible, this book shows how to synthesize complex information about child and adolescent mental health problems into clinically useful, dynamic case formulations. Strategies and tools are provided for analyzing the biological, psychological, social, cultural, spiritual, and developmental factors that may be contributing to the difficulties of clients ages 4-18. Numerous case examples illustrate the steps in crafting a comprehensive formulation and using it to plan effective, individualized treatment. Strategies for overcoming frequently encountered pitfalls in case formulation are highlighted throughout.
