TERMIUM Plus®
The Government of Canada’s terminology and linguistic data bank.
ROUTE LICENSING [2 records]
Record 1 - internal organization data 2009-10-14
Record 1, English
Record 1, Subject field(s)
- Medication
Record 1, Main entry term, English
- reference biologic drug
1, record 1, English, reference%20biologic%20drug
correct
Record 1, Abbreviations, English
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 CONT
A reference biologic drug is a drug already approved on the basis of a complete quality, non-clinical and clinical data package. A reference biologic drug is chosen by the manufacturer of the subsequent entry biologic to demonstrate, in part, similarity between the subsequent entry biologic and the drug authorized for sale in Canada. 1, record 1, English, - reference%20biologic%20drug
Record number: 1, Textual support number: 1 OBS
The reference drug is utilized in the comparability studies required to support the licensing application and provides the basis for the sponsor to select the dose, route of administration, and design of additional clinical trials with the subsequent entry biologic. 1, record 1, English, - reference%20biologic%20drug
Record 1, French
Record 1, Domaine(s)
- Médicaments
Record 1, Main entry term, French
- produit biologique de référence
1, record 1, French, produit%20biologique%20de%20r%C3%A9f%C3%A9rence
correct, masculine noun
Record 1, Abbreviations, French
Record 1, Synonyms, French
- médicament biologique de référence 1, record 1, French, m%C3%A9dicament%20biologique%20de%20r%C3%A9f%C3%A9rence
correct, masculine noun
Record 1, Textual support, French
Record number: 1, Textual support number: 1 CONT
Un produit biologique de référence est un médicament déjà approuvé à partir d'un ensemble complet de données cliniques et non cliniques en matière de qualité. Le médicament de référence est choisi par le fabricant du produit biologique ultérieur pour démontrer, en partie, la similarité entre ce dernier et un médicament dont la vente est autorisée au Canada. 1, record 1, French, - produit%20biologique%20de%20r%C3%A9f%C3%A9rence
Record number: 1, Textual support number: 1 OBS
Le médicament de référence est utilisé dans les études de comparabilité qui sont nécessaires pour appuyer la demande d'homologation et sert de fondement au promoteur au moment de déterminer la dose, la voie d'administration et le plan des essais cliniques additionnels sur le produit biologique ultérieur. 1, record 1, French, - produit%20biologique%20de%20r%C3%A9f%C3%A9rence
Record 1, Spanish
Record 1, Textual support, Spanish
Record 2 - internal organization data 2001-11-05
Record 2, English
Record 2, Subject field(s)
- Air Transport
Record 2, Main entry term, English
- route licence
1, record 2, English, route%20licence
correct, officially approved
Record 2, Abbreviations, English
Record 2, Synonyms, English
- route licensing 1, record 2, English, route%20licensing
correct, officially approved
Record 2, Textual support, English
Record number: 2, Textual support number: 1 OBS
route licence; route licensing : terms officially approved by the International Civil Aviation Organization(ICAO). 2, record 2, English, - route%20licence
Record 2, French
Record 2, Domaine(s)
- Transport aérien
Record 2, Main entry term, French
- autorisation d'exploitation de route
1, record 2, French, autorisation%20d%27exploitation%20de%20route
correct, feminine noun, officially approved
Record 2, Abbreviations, French
Record 2, Synonyms, French
Record 2, Textual support, French
Record number: 2, Textual support number: 1 OBS
autorisation d'exploitation de route : terme uniformisé par l'Organisation de l'aviation civile internationale (OACI). 2, record 2, French, - autorisation%20d%27exploitation%20de%20route
Record 2, Spanish
Record 2, Campo(s) temático(s)
- Transporte aéreo
Record 2, Main entry term, Spanish
- permiso de explotación de ruta
1, record 2, Spanish, permiso%20de%20explotaci%C3%B3n%20de%20ruta
correct, masculine noun, officially approved
Record 2, Abbreviations, Spanish
Record 2, Synonyms, Spanish
Record 2, Textual support, Spanish
Record number: 2, Textual support number: 1 OBS
permiso de explotación de ruta: término aceptado oficialmente por la Organización de Aviación Civil Internacional (OACI). 2, record 2, Spanish, - permiso%20de%20explotaci%C3%B3n%20de%20ruta
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