Altasciences

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


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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
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AltasciencesBy The Altascientist

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