There are lots of ideas out there for improving the safety of drug tests - but the efficacy of pre-clinical systems is not often one of them. This Duff report may be an exception - at least the reporting on the report in an industry newsletter:
Duff reports on clinical trial safety:
"The report called for increased communication between the drug developer and the regulatory body before application for Phase I trials. Pre-clinical trial safety information should be submitted to a database to speed-up the process. This should allow the regulators to identify potential concerns and discuss these with appropriate independent specialist experts. "
This could be part of a system of registering pre-clinical trials, perhaps based on the model for clinical trials registration proposed by the Ottawa Group.
This item also happens to mention the pre-clinical trials in macaqaues:
No adverse effects were observed in monkeys even though they were given a dose 500 times greater than the human volunteers.
0 Comments:
Post a Comment