Late development
The goal of the late development is to confirm the information gained during research and early development, that is, to confirm the efficacy and safety of the drug with clinical studies to get the marketing authorization. During the late development, the large clinical Phase III -studies are carried out and also non-clinical safety studies (like carcinogenic studies) are on-going.
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All results are analysed and confirmed with comprehensive biostatistical methods. In these late clinical studies the drug product should be ready, which requires thorough formulation development. Plans for regulatory actions are made and the data and reports are compiled for a marketing authorization application. Active discussions on the product and on the planned study protocols are on-going with the authorities. Drug safety is followed by collecting the adverse events during studies and the people in drug safety are getting ready for the safety follow-up during marketing. |
In the late Phase of clinical drug development, new modern methods are used for identification of individuals who will benefit from a treatment and those who will be at risk for adverse events. Biomarkers are applied for assessment of efficacy and safety. Genomics is expected to improve the drug development by allowing identification of a population of patients that will benefit most from the drug.
Updated
Dec 17th 2010