Does Stratum Corneum Stripping Predict Activity in Sebaceous Glands?
• Draft Guidance admits that: For antiacne drug products, target sites are the hair follicles and sebaceous glands. • Draft Guidance tries to make the case that stratum corneum predicts the amount of drug absorbed, therefore it predicts the amount in sebaceous gland. • No proof of this. This is a Leap of Faith Assumption. Effect is Drug specific as well.
