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Pediatric formulations [electronic resource] : a roadmap / Daniel Bar-Shalom, Klaus Rose, editors.

Bar-Shalom, Daniel, editor of compilation.; Rose, Klaus, 1953-, editor of compilation.
2014
RJ560
Available Online
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Title
Pediatric formulations [electronic resource] : a roadmap / Daniel Bar-Shalom, Klaus Rose, editors.
ISBN
9781489980113 electronic book
1489980113 electronic book
9781489980106
DOI
https://doi.org/10.1007/978-1-4899-8011-3
Published
New York, NY : Springer, 2014.
Language
English
Description
1 online resource (xv, 439 pages) : illustrations (some color).
Item Number
10.1007/978-1-4899-8011-3 doi
Call Number
RJ560
Dewey Decimal Classification
615.1083
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.
Note
Includes index.
Access Note
Access limited to authorized users.
Source of Description
Description based on online resource; title from PDF title page (SpringerLink, viewed February 3, 2014).
Added Author
Bar-Shalom, Daniel, editor of compilation.
Rose, Klaus, 1953-, editor of compilation.
Series
AAPS advances in the pharmaceutical sciences series, 2210-7371
Linked Resources
Online Access
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All Resources
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.

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