It is the intention of the consortium to establish the methodologies and framework developed through this project as gold standards for paediatric formulation development.
To achieve this aim, it is essential that the wider pharmaceutical community adopt the principles of the proposed development framework, whilst the health agencies incorporate this thinking into evolving guidance on paediatric product development. In this regard, the Academy of Pharmaceutical Sciences (www.apsgb.org) through the age related medicines focus group will lead the process of engagement and lobbying of the wider pharmaceutical industry and health authorities, whilst continuing to extend its reach into the community pharmacy domain, where awareness of formulation issues in the paediatric setting is sub-optimal.
Exploitation of commercially attractive technologies for the development and manufacture of paediatric products identified as a result of supporting evidence generated as part of the project will be undertaken by UK technology SME(s) linked to this program.
To achieve this aim, it is essential that the wider pharmaceutical community adopt the principles of the proposed development framework, whilst the health agencies incorporate this thinking into evolving guidance on paediatric product development. In this regard, the Academy of Pharmaceutical Sciences (www.apsgb.org) through the age related medicines focus group will lead the process of engagement and lobbying of the wider pharmaceutical industry and health authorities, whilst continuing to extend its reach into the community pharmacy domain, where awareness of formulation issues in the paediatric setting is sub-optimal.
Exploitation of commercially attractive technologies for the development and manufacture of paediatric products identified as a result of supporting evidence generated as part of the project will be undertaken by UK technology SME(s) linked to this program.
Predictive in-vivo performance of a paediatric medicine.
The in-vitro and in-silico techniques to predict in-vivo performance of paediatric medicines developed under this program, including use of age appropriate, biorelevant dissolution, in-silico models of drug absorption and physiologically based pharmacokinetic models will be used to assess the submitted compound/formulation
The in-vitro and in-silico techniques to predict in-vivo performance of paediatric medicines developed under this program, including use of age appropriate, biorelevant dissolution, in-silico models of drug absorption and physiologically based pharmacokinetic models will be used to assess the submitted compound/formulation
Predictive Paediatric Taste Assessment
An array of methodologies and techniques developed and collated under this project for predicting the taste of active pharmaceutical ingredients and paediatric formulations in children will be applied to the submitted compound/formulation.
An array of methodologies and techniques developed and collated under this project for predicting the taste of active pharmaceutical ingredients and paediatric formulations in children will be applied to the submitted compound/formulation.