I am looking for information on the newly required studies by the
FDA that includes Reproductive Toxicology for new vaccines being developed
for licensure in the United States. Animal reproductive studies on vaccines
have
not been required by the FDA in the past because the vaccines are not
repeatedly administered on a daily basis, but rather drawn out to include only
a few inoculations over weeks or months. I would conclude that the studies
would
examine the effects of estrous cycles, an ELISA to determine antibody
response, and histopathology of the testes (spermatogenesis). Note
that the studies should have no affect on the licensure status other than to
amend the drug package insert stating the results of the studies.
The problem I'm having, and which I need your help, is developing a
cost/schedule model. There are many factors driving the different models I
have in mind, i.e., do we use mouse or monkey (big difference in funding
requirements), what assays to use (could also drive costs). I feel confident
that these studies would be conducted using an animal model (murine to begin I
hope -- better able to track and easier to handle). Any one have ideas
who/where to find such information? I have already spoken with the FDA, and it
appears this is still a gray area on what is required. I'm sure everyone
doing research work that will end up in an FDA license will have to address
these new requirements (a heads up). Any help is appreciated.
Robb Minter
Cost Account Manager
US Joint Vaccine Acquisition Program Initiative
MinterR at DynPort.Com (work)
VHC1000 at aol.com (home)
