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.
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.
Height:
Width:
Spine:
Weight:0.00