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.
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.
Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
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.
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:
Download or read book Paediatric Formulation Design and Development written by Nunzio Denora and published by . This book was released on 2021 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.
Download or read book Pediatric Drug Formulations written by Milap C. Nahata and published by . This book was released on 1990-01-01 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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:
Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
Download or read book Paediatric Drug Handling written by Ian Costello and published by Pharmaceutical Press. This book was released on 2007 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of all of the issues pharmacists serving pediatric patients must consider. Chapters relating to pharmacogenomics, medication error prevention, compounding, and government regulations are extremely informative.
Download or read book Specialty Competencies in Clinical Child and Adolescent Psychology written by Alfred J. Finch, Jr. and published by Oxford University Press. This book was released on 2012-02-03 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: The specialty of clinical child and adolescent psychology has a history that dates back to the turn of the century when the first psychological clinic for children was reportedly established. As it is currently applied, this broad and wide-ranging specialty took organizational shape from the 1960s through the 1990s, and today child and adolescent psychology shares many characteristics and plays a collaborative role other specialties within professional psychology. These include clinical psychology, cognitive and behavioral psychology, school psychology, and clinical health psychology. In this volume, Dr. Finch and his co-authors provide a comprehensive demonstration of the competencies involved in this specialty, extending far beyond the scope of the age of its identified patient population. Offering an evidence-based best practices model of intervention informed by an integration of multiple professional competencies from a range of other specialty areas, this book is an invaluable resource for all those interested in pursuing the clinical child and adolescent specialty practice. Series in Specialty Competencies in Professional Psychology Series Editors Arthur M. Nezu and Christine Maguth Nezu As the field of psychology continues to grow and new specialty areas emerge and achieve recognition, it has become increasingly important to define the standards of professional specialty practice. Developed and conceived in response to this need for practical guidelines, this series presents methods, strategies, and techniques for conducting day-to-day practice in any given psychology specialty. The topical volumes address best practices across the functional and foundational competencies that characterize the various psychology specialties, including clinical psychology, cognitive and behavioral psychology, school psychology, geropsychology, forensic psychology, clinical neuropsychology, couples and family psychology, and more. Functional competencies include common practice activities like assessment and intervention, while foundational competencies represent core knowledge areas such as ethical and legal issues, cultural diversity, and professional identification. In addition to describing these competencies, each volume provides a definition, description, and development timeline of a particular specialty, including its essential and characteristic pattern of activities, as well as its distinctive and unique features. Written by recognized experts in their respective fields, volumes are comprehensive, up-to-date, and accessible. These volumes offer invaluable guidance to not only practicing mental health professionals, but those training for specialty practice as well.
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.
Download or read book Multiparticulate Drug Delivery written by Ali R. Rajabi-Siahboomi and published by Springer. This book was released on 2017-05-26 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authored by leading experts from academia, users and manufacturers, this book provides an authoritative account of the science and technology involved in multiparticulate drug delivery systems which offer superior clinical and technical advantages over many other specialized approaches in drug delivery. The book will cover market trends, potential benefits and formulation challenges for various types of multiparticulate systems. Drug solubility, dose, chemistry and therapeutic indications as well as excipient suitability coupled with manufacturing methods will be fully covered. Key approaches for taste-masking, delayed release and extended release of multiparticulates systems are of significant interest, especially their in-vivo and in-vitro performance. In addition, the principles of scale-up, QbD, and regulatory aspects of common materials used in this technology will be explained, as well as recent advances in materials and equipment enabling robust, flexible and cost-effective manufacture. Case studies illustrating best practices will also make the book a valuable resource to pharmaceutical scientists in industry and academia.
Download or read book Guide to Paediatric Drug Development and Clinical Research written by Klaus Rose and published by Karger Medical and Scientific Publishers. This book was released on 2010-01-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 681 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.
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.
