Why are our services and expertise so important now?
Legislation from the European Medical Agency (EMA) and the FDA (Paediatric Study Plan (PSP)) aims to safeguard patients against unacceptable tasting or unpalatable medicine. Sensory and consumer research must become an integral part of your product development to ensure palatability of your medicine.
Trained Volunteers for Analytical Assessments
Used to carry out analytical assessments such as descriptive sensory profiling
Palatability Testing using Naïve Volunteers
When a naïve volunteer provides a hedonic reaction, they measure acceptability and palatability
Consultancy / Training Services
SRLPharma provide consultancy services for pharmaceutical and biotechnology companies keeping their research in-house
Palatability
The palatability of medicines is one of the most important factors likely to influence patients’ compliance and adherence to therapeutic regimens and outcomes. The European Medicines Agency has defined palatability as “the overall appreciation of an (often oral) medicinal product in relation to its smell, taste, aftertaste and texture (i.e. feeling in the mouth), determined by the characteristics of the active substance, the way the active substance is formulated into a finished medicinal product, and by the characteristics of the excipients”.
Paediatric Implementation Plan
The Paediatric Regulation which came into force in the EU in 2007 aims at encouraging manufacturers to develop medicines for children’s specific therapeutic needs.
The regulations oblige developers to provide specific plans (PIP – Paediatric Implementation Plan) to show how they intend to develop their medicine for use by children. Elements such as the inclusion of a description of the measures to be carried out and a description of how the medicine’s formulation will be adapted to make its use more acceptable to children is required.
In the plan, the needs of all age groups, from birth to adolescence, as well as the timings of these measures in children compared to adults needs to be considered.
