Dermal drug delivery approaches are on the rise in a variety of therapeutic areas, including reformulation of existing medications. In many instances, the improvements in delivery systems can lead to a successful 505(b)(2) application, extending the patent life of a drug for its sponsor, or creating a marketing opportunity for a company developing dermal delivery of an already marketed drug. New medications are being specifically designed for dermal delivery, and advancements in the field continue as innovative approaches are being tested for the market. 

In this audiobook, we review the specific nonclinical requirements to move a dermal program forward to Phase I clinical trials, as well as the approaches and considerations that minimize inherent challenges. 

Chapters: 
- 1:32 — Current Trends in Dermal Delivery Systems 
- 3:38 — Managing Challenges in Dermal Drug Development
- 5:43 — Species Selection for Dermal Studies 
- 7:49 — Commonly Required Nonclinical Studies 
- 9:02 — Dermal-Specific Studies
- 11:02 — Case Study
- 14:27 — Conclusion 

Read Issue 39 instead: https://www.altasciences.com/sites/default/files/2024-04/the-altascientist-issue-39-nonlcinical-dermal-studies.pdf

Issue 39 — Considerations for Nonclinical Dermal Studies: Advancing to Phase I

As an end-to-end CRO/CDMO, we have expert knowledge in all early stages of drug development, and we’re sharing that knowledge with you in The Altascientist: The Audiobook. 

Each issue is a deep dive into a specific area of early-phase drug development, providing insider tips, considerations, and case studies. 


Altasciences is a drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

New tracks tagged #dermal #clinicaltrials #firstinhuman