We use in vitro skin penetration data extensively in our research and
development efforts. I have an interest in utilizing in vitro skin
penetration data as a substitute, when appropriate, in place of PK
studies for formulation development and safety assessment. In fact I
was just at FDA today when this point came up in one of our discussions.
One of my colleagues provided a copy of an article obtained at the SOT
last month which compared dermal absorption using in vitro and in vivo
methods. I'll find the reference and post it, but please email me
privately and I can provide you more information.
Greg Wagner, Ph.D.
spirited at aimnet.com
>> I am looking for expert opinions on the value of in-vitro experiments vs
> in-vivo radiolabeled PK studies for determining the rate of skin
> permeation of chemicals. I am particularly interested in organic solvents
> such as DMSO, which is thought to have a high rate of dermal permeation.
>> Despite the commonly held belief in scientific circles that DMSO "flies
> through the skin" I have been unable to find a reliable PK study to
> confirm this. I am skeptical of in vitro studies which tend to use either
> cadaver skin or live epidermis.
>> If you have any specific PK data on DMSO or comparisons between in-vitro
> and in-vivo Kp values for the same chemical, please let me know...
>> Thank you in advance for your help...
>> Dan P.