Preparing for Regulatory Review and Reimbursement Decisions A Case for Cooperation between Regulatory Authorities, Sponsors and Health Technology Assessment Agencies

摘要

The process of drug discovery, development and regulation has been described as a series of incremental advancements punctuated by periodic, radically innovative paradigm shifts. Keystone advancements in this modern phase of medicines discovery have included the refinement of targeted combinatorial chemistry, the practical application of high-throughput screening technologies, advances in data mining and bioinfor-matics, and the use of proteomics and biomarkers from the earliest phases of discovery and throughout the development lifecycle.