Translational Research through Regulatory Policy changes
Topical dermatological products worldwide face little competition from the market and hence have seen dramatic rise in prices. Regulatory approvals of generic topical products lag the market requirements due to lack of appropriate and accurate technologies that can assess drug levels at the site of action. In the absence of these, clinical equivalence studies (clinical trials) have been a gold standard. Our work in collaboration with the world’s leading regulators (FDA) has developed the conceptual framework to describe the physicochemical and structural arrangement of matter in semisolid dosage forms, devised technical and reproducible methods for characterising these attributes and elucidated how critical quality attributes directly and predictably modulate the rate and extent of drug delivery.
Within the last 4–5 years, the characterisation-based approaches that have been developed in collaboration with UQ are being used in generic product developed without the need for costly and time-consuming clinical studies. In the United States and Europe alone, more than 80 regulatory guidance documents and guidelines now recommend the use of these new techniques to develop topical and transdermal products.
Associate Professor Yousuf Mohammed, School of Pharmacy and Pharmaceutical Sciences
Associate Professor Yousuf Mohammed's research predominantly focuses on skin drug delivery, topical and transdermal product development and their regulation, microneedles, and nanomaterials. Notably, he acts as the Principal Investigator for multiple high-stakes, US FDA-funded projects. His studies on the critical quality attributes and bioequivalence of semisolid formulations have directly shaped US FDA product-specific guidance documents. These models now serve as the active blueprint for the global generic drug industry to safely accelerate products to market. Having delivered more than 75 presentations at international conferences, his ability to distil complex pharmacokinetics and regulatory science into practical insights is highly regarded worldwide.
Zoom link: https://uqz.zoom.us/j/88084415939
Enquiries: spps.researchadmin@uq.edu.au
About Research-to-Impact Talks
SPPS Research-to-Impact talks are presentations of high-quality scholarly work with broad appeal and research impact.
The wider School community is invited to attend, including academic and professional staff, special guests, visitors, as well as HDR, postgraduate, and undergraduate students.