Software verification and validation: The dossier should contain information on the s ...

Stability (excluding specimen stability): This section should describe claimed shelf ...

Animal studies: (i) Where studies in an animal model have been undertaken to provide ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

In use stability: This section should provide information on in use stability studies ...