Since the first edition in 2014 pediatric drug development has expanded in several dimensions. There have been significant changes on the technical level, as have been in the assessment of the regulatory demands. This 2nd edition gives an overview and update on both aspects. This is not a how to formulate textbook, but an attempt to equip the reader with necessary information on the technical, the regulatory, and the historical level.

Written in cooperation with the EuPFI -European Pediatric Formulation Initiative and the AAPS Contributors are leading globally recognized experts in the field Provides a comprehensive treatment of pediatric drug development

Autorentext

Professor Hannah Batchelor is a pharmaceutical scientist who has worked in academia, the NHS and within pharmaceutical industry. She is currently based at the Strathclyde Institute of Pharmacy and Biomedical Science, University of Strathclyde in Glasgow. She is Director of Research for the Strathclyde Institute of Pharmacy and Biomedical Sciences.

She works on the design and manipulation of medicines to create age appropriate drug formulations to maximise clinical efficacy in paediatric patients. Her research interests lie in the optimisation of drug formulations to maximise their biopharmaceutical performance and acceptability to children. Her research is informed by the views of children, young people and parents to ensure that the patients are at the centre of new developments. She is also the director of the GIBio facility at Strathclyde which is an advanced dissolution apparatus designed to provide near clinical data to inform formulation development.

Hannah is passionate about pharmaceutical sciences and is motivated to inspire the next generation of scientists.

Dr. Klaus Rose is CEO of klausrose Consulting, Switzerland and advises on pediatric drug development and how to comply with FDA and EMA pediatric requirements. He has studied Latin languages, psychology and medicine. After postgraduate clinical training in general medicine in Germany and England, he joined the pharmaceutical industry. He has held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis from 2001 to 2005 and was Global Head Pediatrics Roche from 2005 to 2009. After a year with a regulatory consultancy, he established his own business. Dr. Rose is a frequent speaker on international conferences on pediatric drug development, organizes trainings and publishes on a regular base.

Inhalt

Defining a paediatric patient.- Paediatric Development and Pharmacotherapy.- General Considerations for Pediatric Formulation Development: Setting Target Product Profiles.- Acceptability of formulations: testing strategies.- Palatability of oral dosage form - considerations for pediatric patients.- Taste Masking Technologies.- ORAL LIQUID FORMULATIONS.- Paediatric Solid Formulations.- Micropellets a modern multiparticulate technology platform for pediatric medicines.- Oral semi-solid Formulations.- Buccal/Sublingual Drug Delivery for the Paediatric Population.- Topical and transdermal drug delivery.- Parenteral.- The Challenges of Paediatric Pulmonary Drug Delivery.- Paediatric formulations: Nasal, Ocular and Otic drug delivery.- Rectal drug delivery.- Compounding for Children The Compounding Pharmacist.- Excipients and Active Pharmaceutical Ingredients.- Clinical Testing in Children.- Bridging of formulations used during clinical development.- Modelling and Simulation for Paediatric Formulation development.- Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the USA and Implementation of Quality by Design.- Paediatric Pharmaceutical Legislation and Its Impact on Adult and Paediatric Drug Development: The EU Regulatory View.- Global paediatric legislation for paediatric medicines in LMIC regions.- Impact of the US & EU Pediatric Pharmaceutical Legislation.- The Dangerous Business of Predicting the Future.