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Therefore, trials that assess drug efficacy on exacerbations are done late in clinical development programmes.
Clinical development programmes exploring SC formulations of rituximab or trastuzumab coformulated with rHuPH20 are underway.
Previous clinical development programmes have pointed to the importance of the initial treatment phase.
However, a particular challenge to global clinical development programmes is the relevance of the content of a PRO scale to the culture and lifestyle of all country centres.
Furthermore, FDA staff are experts on the clinical development programmes for these drugs and were already familiar with many of these studies.
Other than the potential differences in predisposition or risks for these events between the diseases studied, another possible explanation is the smaller population sizes of these clinical development programmes compared with those for RA and CD.
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One patient in the psoriasis clinical development programme developed cutaneous lupus erythematosus, which was not considered an SAE by the investigator.
This report summarises BP findings from the erenumab clinical development programme.
In the Phase III clinical development programme, both drugs appeared effective and reasonably safe.
TJ reviewed and interpreted the data, wrote the manuscript and is responsible for the exploratory clinical development programme of ACZ885.
The data were fully anonymised and were available as a component of an ongoing clinical development programme.
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