作者: Joel Krasnow
DOI: 10.1007/978-1-84882-710-3_16
关键词:
摘要: Product development within the pharmaceutical and medical device industries is shaped by market regulatory forces. Patients payers are only willing to pay for products that represent true innovation value. As good branded lose exclusivity, bar with respect product performance raised new products. The healthcare industry has successfully demonstrated value identifying populations significant unmet need through companion diagnostics or orphan diseases. hurdle approval steadily increased key metric being benefit compared its risk. Clinical trial size complexity markedly in order meet hurdles risk assessment. Imaging can document pathophysiology of many disorders. Through various methods, imaging be employed as a biomarker early development, tool population specific product, an endpoint registration trials. This chapter reviews changing landscape role effective implementation technology clinical development.