Internal Exposure:  Enabling In Vitro to In Vivo Extrapolation (IVIVE) for Human Skin S9 Metabolism

The objectives of this project are to:

1. Provide guidance to scientists, regulators, and contract labs on how to prepare, store and maintain human skin S9
2. Provide guidance to scientific community on the amount of skin S9 protein obtained from human skin
3. Establish equations for scaling in vitro skin S9 metabolism data to estimates of in vivo metabolism Complete illustrative examples / case studies that compare results of IVIVE (objectives 2 and 3) to ex vivo skin data (penetration + metabolism) and/or human dermal PK data.