"A short bioanalytical feasibility is the most efficient way preparing optimally for first in-vivo studies" was the message of the presentation given by Christian Kikuta and Martin van Dam.
The afternoon was dedicated to the subject "Preparing for 1st In-Man / Preclinical Strategies", organized by LISA, the Austrian life science cluster organization.
In the early phase of developing a compound obviously the bioanalytical behavior is vastly unknown. Yet the upcoming TOX or Dose Range Finding Study want to be planned optimally, in the light of the large lumps of budget absorbed by them.
A bioanalytical feasibility is a 2-4 day ballpark investigation of the bioanalytical behavior in plasma (or respective matrices). Output are rudimentary data on: stability in plasma, detectability, linearity, rough limits of detection and selectivity.
In combination with a pilot pre-clinical study administering the compound to 2-3 rodents, even important first information on bioavailibility can be gained, such as first-pass-effect, metabolism or protein binding.
The benefits are obvious:
- Reduction of Risk and disclosing latent "bad news"
- Estimation of effort and cost for upcoming in vivo trials
- Knowing scope of data to expect of pre-clinics
- Improved position towards VCs and authorities
In context with in-vivo pilot study:
- Pre-conclustions on administrative route
- Impression of bioavailibility / metabolism
- Orientation for dose range
Summary: Cut Risk and Cost with Preliminary Data.