Thursday, September 24, 2020
Early phase clinical trials are becoming increasingly complex, potentially leading to a higher risk of failure. But careful planning and attention to some key areas in the early phase can mitigate the challenges.
The first FDA-approved therapeutic monoclonal antibody (mAb) was muromonab in 1986, and since then, numerous mAb drugs have been approved, and many more are in the later stages of clinical development. In the main, mAbs are being developed against ...
One of the major challenges when undertaking a first-in-human (FIH) clinical trial is how to appropriately plan and analyze the pharmacokinetics (PK) of a new drug. Although PK assessment in the earliest stages of clinical development provides ...