spacer
home > epc > spring 2009 > skin deep
PUBLICATIONS
European Pharmaceutical Contractor

Skin Deep

The safety battery for topically applied products typically includes evaluation of the final to-be-marketed formulation for cutaneous toxicity (most notably dermal irritation) potential for inducing contact sensitisation and photoallergic contact sensitisation, and phototoxic potential. Even though these Phase I safety studies are an integral part of almost every topical development programme and help lay the groundwork for responsible and safe clinical development in later phases, there are no current FDA or EMEA guidelines specific to these studies. Unfortunately, in the absence of guidelines setting down the requirements and designs for these studies, sponsors are often at a loss for rational designs and to manage agency expectations. This article presents an overview of the basic study designs for standard dermal safety tests in humans.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Betsy Hughes-Formella is Director of Business Development and Consulting at bioskin GmbH. She received her MS and PhD in Physiology from the University of Georgia, Athens, before moving to Germany to join a research team at the University Medical Center in Hamburg. Betsy’s research interests were in the areas of steroid biochemistry and the pathogenesis of melanoma. She joined bioskin in 1993. In her current role, she is responsible for the coordination of the company’s business development activities and is a consultant and advisor for clinical development concepts and study designs.

Joachim Fluhr has been Medical Director at bioskin GmbH since 2007. He received his MD at Johannes-Gutenberg-University of Mainz, Germany, and was trained in dermatology at the Department of Dermatology, Karlsruhe, Germany. He is a board-certified dermatologist. Joachim performed clinical trials in Karlsruhe and Pavia, Italy, before joining the UCSF-based team of Peter Elias in San Francisco for two years. After returning to Germany he was an attendant at the Friedrich-Schiller-University of Jena where he also headed the Skin physiology Laboratory for over four years. Currently, Joachim also holds a position as adjunct Lecturer in the Department of Dermatology, Charité, Berlin.

spacer
Betsy Hughes-Formella
spacer
spacer
spacer
Joachim Fluhr
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Wool packaging firm’s green scheme goes ‘beyond recycling’

An award-winning company that has spent more than 10 years innovating in sustainable packaging has launched a scheme that it says goes ‘beyond recycling’ – by allowing the end user to return their packaging directly to them to be used again.
More info >>

White Papers

Data Technology as a Catalyst for Growth in the Life Sciences

AIGENPULSE

The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
More info >>

 
Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement