Planning New Drug-Development Strategic

摘要

Delineating the Roles of Cell- and Protein Analytical Chemistry-Based Assays. One of the major causes of delay in the pharmaceutical development process is inadequate forward planning on the use of analytical methods. Nowhere is this more acute than in the implementation of cell-based assays. It is never too early to develop these methods as the need to identify, quantify, and measure the potency of the drug substance is vital in producing meaningful and interpretable data. Before going into more detail regarding the development of an analytical package, there are a number of considerations to bear in mind. First, we have found at Covance (www.covance.com) that it often takes longer than expected to develop, evaluate, validate, and transfer the majority of assays. This is even more of.an issue for bioassays that can take six months or longer to transfer and validate.