DEVELOPMENT CHALLENGES

OTHER NON-CLINICAL DEVELOPMENT TASKS

 

Further to preclinical development, additional diverse and critical non-clinical tasks still need to be undertaken whilst clinical trials are underway.

 

These may include further development of the drug substance and finished product manufacturing processes and of the analytical methods, as well as production of more batches.

 

Additional toxicology studies, such as carcinogenicity and reproductive toxicity studies, are also often required during clinical development.