ABSTRACT
For topical dermatologic drug products, PK measurements in blood, plasma, and/or urine are usually not feasible to document BE because topical dermatologic products generally do not produce measurable concentrations in extracutaneous biological fluids. The BE determination for these products is thus often based on PD or clinical studies. An additional approach is to document BE through reliance on measurement of the active moiety(ies) in the stratum corneum. This approach is termed dermatopharmacokinetics (DPK). Although measurement of the active moiety(ies) in blood or urine is not regarded as an acceptable measurement of BE for dermatologic drug products, it may be used to measure systemic exposure.
