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Title Pediatric formulations : a roadmap / Daniel Bar-Shalom, Klaus Rose, editors
Published New York, NY : Springer, 2014


Description 1 online resource (xv, 439 pages) : illustrations (some color)
Series AAPS Advances in the Pharmaceutical Sciences Series, 2210-7371
AAPS advances in the pharmaceutical sciences series, 2210-7371
Contents Pediatric Development: Anatomy -- Age, Weight, Body Surface and Stature, Organ Development -- Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics -- Pediatric Development? Gastrointestinal -- How to Estimate the Dose to be Given for the First Time to Pediatric Patients -- The Clinical Relevance of Pediatric Formulations -- General Considerations for Pediatric Oral Drug Formulation -- Orosensory Perception -- Flavor Is Not Just Taste: Taste Concealing -- Liquid Formulations -- Paediatric Solid Formulations -- Semi-Solid Formulations -- The Challenge of Automated Compounding -- Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation -- Buccal/Sublingual Drug Delivery for the Paediatric Population -- Topical and Transdermal -- Parenteral Liquids for Intravenous and Transdermal Use -- The Challenges of Paediatric Pulmonary Drug Delivery -- Nasal, Ocular and Otic Drug Delivery -- Rectal Drug Delivery -- Intraosseous Infusions in Infants and Neonates -- Compounding for Children? The Compounding Pharmacist -- Food Ingredients -- Excipients and Active Pharmaceutical Ingredients (APIs) -- Clinical Testing in Children -- Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the United States and Implementation of Quality by Design -- Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory View -- Pediatric Pharmaceutical Legislation in USA and EU and their impact on Adult and Pediatric Drug Development -- Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation -- The Dangerous Business Of Predicting The Future
Summary As the first book that specifically addresses pediatric formulations in the context of drug development, Pediatric Formulations: A Roadmap covers anatomy and physiology of children as well as the technical state of the art, gives hints about where to find inspiration, and provides a suitable background on the regulatory framework. Existing books on pediatric formulations mainly discuss compounding at the pharmacy. This is not a "how to formulate" textbook for pharmaceutical scientists; the subtitle "A Roadmap" indicates that we are on a path in largely unexplored territory. It is an attempt to equip the reader with necessary information on how to get started with the appropriate mindset. Among medicinal specialties, pediatrics is a young discipline. The potential dangers of medicine were often underestimated in earlier times. Cough suppressants labeled as "suitable for children and adults" a hundred years ago could kill children as they contained opioids. Since then, a complex framework has evolved, with physicians, pharmacists, drug development companies, generic companies, academic scientists, regulatory authorities, reimbursement organizations, patients and children's parents as key players. The position of children in our society has changed dramatically during the last century. Children were protected against clinical trials, yet thanks to clinical trials, many more children with cancer survive today. The development of age-adjusted drug formulations is not only a technical challenge. For new drugs today, there are laws both in the United States and the European Union that compel the research-based pharmaceutical industry to also consider children during drug development. One of the major demands of authorities is the development of age-appropriate formulations
Notes Includes index
Bibliography Includes bibliographical references at the end of each chapters and index
Notes English
Online resource; title from PDF title page (SpringerLink, viewed February 3, 2014)
In Springer eBooks
Subject Pediatric pharmacology.
Drugs -- Design.
Pharmaceutical Preparations
Drug Delivery Systems
Drug Design
MEDICAL -- Pharmacology.
Pediatric pharmacology.
Genre/Form Electronic books
Form Electronic book
Author Bar-Shalom, Daniel, editor
Rose, Klaus, 1953- editor.
ISBN 9781489980113