商品簡介
This book compares the GCP regulations of the US, EU, Japan, Australia, and Canada, as well as draft documents issued by the ICH and the FDA. It provides insight into the obvious and the more subtle differences between the GCP of the major national and multinational entities. Section 1 presents a side-by-side comparison of the tables of contents of six different GCPs, allowing instant recognition and understanding of the similarities and differences among them in organization and scope. Section 2 reorganizes the texts of the six GCPs into sixteen subject areas. Section 3 includes verbatim texts of the six GCP regulations in their original order and Section 4 is a glossary.
