Development of Paediatric Medicines - Glossary
2. Glossary:
The definitions given below apply to the terms as used in these guidelines. They may have different meanings in other contexts.
Child-Resistant Container:
A form of packaging difficult for young children to open but not unduly difficult for adults to open properly.
Flexible Dosage Form:
A solid dosage form that can be administered to patients in more than one manner, e.g. may be dispersed or taken orally as a whole.
Labelling Information:
Information to the user provided on the package label or in the patient information leaflet.
Mini-Tablet:
A tablet of no more than 4 mm diameter.
Off-Label Use:
Use of a medicine outside the scope of regulatory authorization.
Platform Technology:
Technique, including formulation and related processes, which can be used to obtain different dosage forms, different strengths and/or accommodate different APIs.
Development of Paediatric Medicines: points to consider in formulation,
(Annex 5, WHO Technical Report Series 970, 2012)
