Development of Paediatric Medicines - Glossary

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)

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