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

According to the World Health Organization, at least a billion people are currently living with vision impairment from a preventable or treatable source. The main conditions causing their distance vision impairment or blindness are cataracts, refractive error, age-related macular degeneration, glaucoma, diabetic retinopathy, and presbyopia. 

Precedence Research reports that the global ophthalmic drug market size is estimated to double in 10 years, from $34.6 billion in 2021 to an estimated $68.93 billion by 2030. The development of pharmacological interventions for many of these conditions has been accelerating, supported by new delivery methods and formulation approaches. For conditions that require surgery or corrective devices, eye drops are an important part of diagnosis, and pre- and post-surgery treatment plans. 

In this issue of The Altascientist, we explore how to meet the challenges of formulation development for ocular therapies. 


Issue 43 — Advancing Vision Care With Formulation and Manufacture of Ocular Therapeutics

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.

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

The Altascientist

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