Topical Drug Development -- Evolution of Science and Regulatory Policy

Monday, July 29, 2019
8:30 a.m.-5:00 p.m.
University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore MD 21201
Ann Anonsen
301 405 0285

About the July 29th & 30th Event:

News story about this event

The assessment of dermal absorption in topical drug development is a relative new-comer to clinical pharmacology and pharmacokinetics, in general. This has historically been due to the lack of both sufficient analytical models and standardized assessment protocols. In the early 1990s, the U.S. FDA initiated the development of a “Maximal Usage Study or MUsT” paradigm in the Division of Dermatology and Dental Drug Products (DDDP). This paradigm was designed to both assist in the evaluation of in vivo safety by providing direct assessment of plasma levels following application of topical products, and to provide information on the effects of disease and formulation on dermal penetration.

Since its introduction, the MUsT paradigm has been used in the development program over every topically applied New Drug Application in the U.S. This paradigm has been presented at numerous national and international meetings and has been published by the FDA. Since 2014, with the increased scrutiny of topical antiseptics and sunscreens, the MUsT paradigm has been adopted into the area on non-prescription drug products via both draft and final rules for antiseptics, a safety and effectiveness guidance for sunscreens, and now, the draft and pending final rule for sunscreens. In parallel, in vitro permeation methods have progressed to the point where they can be used, in conjunction with the in vivo MUsT paradigm, as a tool in the successful development of topical drugs.

This symposium will bring together stakeholders from the FDA, academia, and industry to discuss the underpinnings of the MUsT program, the successful incorporation of the MUsT in drug development, and the utilization of in vitro methods in product development. Additionally, data from the recent FDA publication of their pilot sunscreen MUsT program will be discussed along with a discussion as to how this information can be used to augment and improve the development of non-prescription drugs, both under the rubric of an NDA and the Monograph system.

Program Objectives:

  1. To present the background of the current regulatory policy in the area of dermal absorption and its underpinnings.
  2. To provide examples of the successful incorporation of both in vivo (Maximal Usage Trials) and in vitro (percutaneous permeation studies, i.e., IVPT) in drug development.
  3. To facilitate discussion as to the design elements and concerns of both in vivo and in vitro methods in the new drug and over-the-counter drug space.
  4. To stimulate discussion between interested parties in the evolution of science in the area of topical drug development and dermal absorption testing.
Special Accommodations 

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at at least seven (7) days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made two (2) weeks in advance of the workshop, and should be sent directly to the FDA Interpreting Services Staff at

For More Information:

More information about this workshop, including registration, an agenda, and information about how to submit your poster title and parking and directions, is available on this website.

If you have any additional questions about this workshop, please contact



Audience: Public 

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