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Pediatric Formulations


Pediatric Formulations
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Pediatric Formulations


Pediatric Formulations
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Author : Daniel Bar-Shalom
language : en
Publisher: Springer Science & Business Media
Release Date : 2014-01-30

Pediatric Formulations written by Daniel Bar-Shalom and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-01-30 with Medical categories.


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.



Pediatric Drug Formulations


Pediatric Drug Formulations
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Author : Milap Nahata
language : en
Publisher:
Release Date : 2014-01-01

Pediatric Drug Formulations written by Milap Nahata and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-01-01 with Medical categories.




Extemporaneous Formulations For Pediatric Geriatric And Special Needs Patients


Extemporaneous Formulations For Pediatric Geriatric And Special Needs Patients
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Author : Rita K. Jew
language : en
Publisher:
Release Date : 2021

Extemporaneous Formulations For Pediatric Geriatric And Special Needs Patients written by Rita K. Jew and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Children categories.


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.



Paediatric Formulation


Paediatric Formulation
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Author : Nunzio Denora
language : en
Publisher: MDPI
Release Date : 2021-09-02

Paediatric Formulation written by Nunzio Denora and has been published by MDPI this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-02 with Science categories.


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.



Pediatric Drug Development


Pediatric Drug Development
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Author : Andrew E. Mulberg
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-20

Pediatric Drug Development written by Andrew E. Mulberg and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-20 with Medical categories.


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.



Handbook Of Pharmaceutical Manufacturing Formulations Third Edition


Handbook Of Pharmaceutical Manufacturing Formulations Third Edition
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2019-12-05

Handbook Of Pharmaceutical Manufacturing Formulations Third Edition written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-05 with Medical categories.


The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines



Pediatric Clinical Pharmacology


Pediatric Clinical Pharmacology
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Author : Hannsjörg W. Seyberth
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-09-01

Pediatric Clinical Pharmacology written by Hannsjörg W. Seyberth and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-01 with Medical categories.


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.



Essentials Of Translational Pediatric Drug Development


Essentials Of Translational Pediatric Drug Development
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Author : Elke Gasthuys
language : en
Publisher: Elsevier
Release Date : 2024-07-23

Essentials Of Translational Pediatric Drug Development written by Elke Gasthuys and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-23 with Medical categories.


Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development



Principles Of Perinatal And Pediatric Hiv Aids


Principles Of Perinatal And Pediatric Hiv Aids
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Author : Lala Mamatha M
language : en
Publisher: Wife Goes On
Release Date : 2011-10

Principles Of Perinatal And Pediatric Hiv Aids written by Lala Mamatha M and has been published by Wife Goes On this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10 with Medical categories.


Principles of Perinatal & Pediatric HIV/AIDS is a comprehensive guide to the treatment of children with HIV/AIDS. Beginning with an introduction to HIV infected children, the book following sections consider clinical manifestations of the disease, perinatal and newborn HIV, HIV in adolescence and management of the disease. Authored by international specialists from Europe, Asia, South Africa and the USA, this text includes numerous images and illustrations to enhance learning.



Addressing The Barriers To Pediatric Drug Development


Addressing The Barriers To Pediatric Drug Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2008-08-12

Addressing The Barriers To Pediatric Drug Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-08-12 with Medical categories.


Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.