Replies to post #40893 on Avid Bioservices Inc (CDMO)

[co3aii]

This recently came up on another MB as to why Japan requires separate trials for drugs approved by the FDA. Their reasoning is that they have genetic, racial, homogeneity and they want to assure the drug works in that population. The reverse would be true too, a drug that works there might not work here as eficaciously.

I'll do some looking and get back to you with a source.

[co3aii]

Here is a citation, one of many:

http://books.google.com/books?id=-T2ShwgES8YC&pg=PR13&lpg=PR13&dq=japan+drug+trial+racial+homogeneity&source=bl&ots=xCcqlu8_jd&sig=YQzUI-yUXSagW_gORG2pWUorXgg&hl=en&ei=30ucSqG1B-CFmQf6vtDJBA&sa=X&oi=book_result&ct=result&resnum=1#v=onepage&q=&f=false