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  • Book
    Daniel Bar-Shalom, Klaus Rose, editors.
    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.

    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.
    Digital Access Springer 2014