Presentations

Innovative methodologies to assess cutaneous bioavailability – dermal microdialysis and coherent Raman imaging

February 24th, 2022

Currently, there are several methodologies under investigation by the U.S. FDA for the assessment of cutaneous pharmacokinetics. Thus far, my experience includes two of these methodologies – dermal microdialysis and coherent Raman imaging. Here I will speak to the methodological challenges and solutions to accurately and sensitively quantify active pharmaceutical ingredients as they escape a topical dosage form and permeate deeper into the skin.

PDF to be published soon

Recent advancements in dermal microdialysis to assess topical bioavailability and bioequivalence

AAPS Topical and Transdermal Community Webinar – April 30th, 2021

Dermal microdialysis (dMD) can measure the rate and extent to which a topically administered active pharmaceutical ingredient (API) becomes available within the dermis. However, there have been pitfalls in previous experimental designs that may have compounded the variability typically associated with cutaneous PK estimations. As such there are technical considerations that must be characterized and optimized to ensure an in vivo study is selective, sensitive, discriminating, and reproducible. Utilizing multiple test-sites on the same subject and replicate probes at each site makes it feasible to compare the cutaneous pharmacokinetics of APIs from topical dermatological drug products. Thus, a well-controlled study design can afford investigators the ability to make proper conclusions about dermal bioavailability and bioequivalence  

The dermal dispostion of metronidazole and development of a Level A IVIVR for topical dermatological drug products

10^th Annual Indiana CTSI Disease and Therapeutic Response Modeling Symposium – Jan 20th, 2021

Dermal microdialysis (dMD) can measure the rate and extent to which a topically administered active pharmaceutical ingredient (API) becomes available within the dermis. However, there have been pitfalls in previous experimental designs that may have compounded the variability typically associated with cutaneous PK estimations. As such there are technical considerations that must be characterized and optimized to ensure an in vivo study is selective, sensitive, discriminating, and reproducible. Utilizing multiple test-sites on the same subject and replicate probes at each site makes it feasible to compare the cutaneous pharmacokinetics of APIs from topical dermatological drug products. Thus, a well-controlled study design can afford investigators the ability to make proper conclusions about dermal bioavailability and bioequivalence