The need for reproductive / developmental toxicity studies for biotechnology
derived pharmaceuticals is dependent upon the product, clinical indication and
intended patient population.
The US CBER branch of the FDA recommend the use of the ICH guidance document,
"Studies to International Conference on Harmonisation (ICH) Guidelines
(Topic S5A: Detection of Toxicity to Reproduction for Medicinal Products)".
However, study designs should be modified as appropriate to the class and intended
use of any biological product.
For preventative Vaccines for Infectious Disease Indications, a draft Guidance
for Industry was issued by the US CBER branch of the FDA in 2000. This advised
that reproductive toxicity studies should be conducted for vaccines indicated
for adolescents and adults and for vaccines that are indicated for, or may have
the potential to be indicated for, immunisation of pregnant women.
Studies conducted by HLS on vaccines have all been customised designs with
an appropriate pre-pairing immunisation phase to raise antibody titres before
the start of the experimental phase. Plasma samples are taken at key points
in the study to monitor the immunological response. Studies on other types of
biopharmaceuticals also need to be tailored to intended in-use situations.
Together with our extensive support departments, we provide the full comprehensive
package of tests required for registration and market authorisation, which ultimately
helps speed your product to market.
|
