Pediatric Formulations PDF Download
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Author | : Daniel Bar-Shalom |
Publisher | : Springer Science & Business Media |
Total Pages | : 429 |
Release | : 2014-01-30 |
Genre | : Medical |
ISBN | : 1489980113 |
Download Pediatric Formulations Book in PDF, ePub and Kindle
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 | : |
Total Pages | : |
Release | : 2014-01-01 |
Genre | : Medical |
ISBN | : 9780929375144 |
Download Pediatric Drug Formulations Book in PDF, ePub and Kindle
Author | : Nunzio Denora |
Publisher | : MDPI |
Total Pages | : 205 |
Release | : 2021-09-02 |
Genre | : Science |
ISBN | : 303650740X |
Download Paediatric Formulation Book in PDF, ePub and Kindle
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 |
Total Pages | : 782 |
Release | : 2013-05-20 |
Genre | : Medical |
ISBN | : 1118312058 |
Download Pediatric Drug Development Book in PDF, ePub and Kindle
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 | : Rita K. Jew |
Publisher | : ASHP |
Total Pages | : 239 |
Release | : 2016-03-01 |
Genre | : Medical |
ISBN | : 1585285269 |
Download Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients Book in PDF, ePub and Kindle
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 | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 432 |
Release | : 2012-10-13 |
Genre | : Medical |
ISBN | : 0309225493 |
Download Safe and Effective Medicines for Children Book in PDF, ePub and Kindle
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 | : |
Total Pages | : 0 |
Release | : 2021 |
Genre | : Children |
ISBN | : 9781585286515 |
Download Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients Book in PDF, ePub and Kindle
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 | : |
Publisher | : |
Total Pages | : |
Release | : 2018 |
Genre | : |
ISBN | : 9780929375120 |
Download Pediatric Drug Formulations 7th Edition Book in PDF, ePub and Kindle
Author | : Katharina Manassis |
Publisher | : Guilford Publications |
Total Pages | : 257 |
Release | : 2014-05-19 |
Genre | : Psychology |
ISBN | : 1462515606 |
Download Case Formulation with Children and Adolescents Book in PDF, ePub and Kindle
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.
Author | : Rita K. Jew |
Publisher | : |
Total Pages | : 0 |
Release | : 2010 |
Genre | : Children |
ISBN | : 9781585282456 |
Download Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients Book in PDF, ePub and Kindle
Only 20 percent of marketed medications have appropriate pediatric dosage information readily available. This lack of commercially available formulations challenges geriatric and special needs treatment as well. When seeking answers, pharmacy professionals turn to Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients, 2nd Edition. This one-of-a-kind resource offers information on: * Ingredients * Preparation details and instructions * Storage conditions * Special instructions * Alternatives * Expiration dates * Evidence-based monographs accompany helpful discussions of compounding, preparation methods, legal conditions, documentation, labeling and more. Get 35 Percent More Monographs If you are relying on the 2003 edition for your pediatric, geriatric or special-needs dosage information, it's time to update your library. This Second Edition features 160 total monographs, 35 percent more than the original.