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ASSESSMENT OF HUMAN CADAVER AND RECONSTRUCTED SKIN MODELS TO PREDICT PHARMACOKINETICS OF TESTOSTERONE TRANSDERMAL DRUG DELIVERY PATCHES.0

Myszka1, S.L.W., Husberg1, M.L., Lawton1, J.M., Lippert1, D.R., Harrison2, L.I. 13M Drug Delivery Systems Division, St. Paul, MN, USA, 55144, 23M Pharmaceuticals Division, St. Paul, MN, USA, 55144.
Abstract

Testosterone TDD patches were compared for in-vitro skin permeation characteristics and in the clinic for in-vivo pharmacokinetic parameters. In-vitro evaluations were conducted using both human cadaver and reconstructed skin models in order to determine a model predictive of in-vivo delivery. HCS was chosen at the model most predictive of testosterone in-vivo delivery. The preliminary IVIVC using HCS is very strong (r=0.99971).

Keywords

Dermal absorption, Dermal penetration, Dermal permeation, EpiDerm, Equilvalents, Human skin, Percutaneous absorption, Percutaneous penetration, Permeation, Pre-validation, Prevalidation, Reconstructed human skin, TDD, Testosterone, Testosterone TDD patches, Transdermal, Transdermal drug delivery, Validation

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