Pediatric Formulations

Author : Daniel Bar-Shalom
Publisher : Springer Science & Business Media
ISBN 13 : 1489980113
Total Pages : 429 pages
Book Rating : 4.13/5 ( download)

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Download or read book Pediatric Formulations written by Daniel Bar-Shalom and published by Springer Science & Business Media. This book was released on 2014-01-30 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 9780929375144
Total Pages : pages
Book Rating : 4.49/5 ( download)

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Download or read book Pediatric Drug Formulations written by Milap Nahata and published by . This book was released on 2014-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Nunzio Denora
Publisher : MDPI
ISBN 13 : 303650740X
Total Pages : 205 pages
Book Rating : 4.08/5 ( download)

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Download or read book Paediatric Formulation written by Nunzio Denora and published by MDPI. This book was released on 2021-09-02 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 1118312058
Total Pages : 782 pages
Book Rating : 4.56/5 ( download)

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Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.96/5 ( download)

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Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Milap C. Nahata
Publisher : Harvey Whitney Books Company
ISBN 13 : 9780929375328
Total Pages : 0 pages
Book Rating : 4.27/5 ( download)

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Download or read book Pediatric Drug Formulations written by Milap C. Nahata and published by Harvey Whitney Books Company. This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author :
Publisher :
ISBN 13 : 9780929375120
Total Pages : pages
Book Rating : 4.22/5 ( download)

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Download or read book Pediatric Drug Formulations 7th Edition written by and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Rita K. Jew
Publisher :
ISBN 13 : 9781585286515
Total Pages : 0 pages
Book Rating : 4.16/5 ( download)

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Download or read book Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients written by Rita K. Jew and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Rita K. Jew
Publisher : ASHP
ISBN 13 : 1585285269
Total Pages : 224 pages
Book Rating : 4.66/5 ( download)

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Download or read book Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients written by Rita K. Jew and published by ASHP. This book was released on 2016-03-01 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 1462515606
Total Pages : 257 pages
Book Rating : 4.08/5 ( download)

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Download or read book Case Formulation with Children and Adolescents written by Katharina Manassis and published by Guilford Publications. This book was released on 2014-05-19 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.