Publications by authors named "Carmen Amelia Rodriguez Hernandez"
Article Synopsis
- * An international group is collaborating to tackle regulatory challenges related to microneedles combined with pharmaceuticals for skin application, guided by Quality by Design principles.
- * The resulting 'White Paper' highlights key dosage form classifications, potential critical quality attributes, and aims to create a foundation for regulatory guidance that will help bring safe and effective microneedle products to market faster.
Microneedle Array Patches (MAPs) are an emerging dosage form that creates transient micron-sized disruptions in the outermost physical skin barrier, the stratum corneum, to facilitate delivery of active pharmaceutical ingredients to the underlying tissue. Numerous MAP products are proposed and there is significant clinical potential in priority areas such as vaccination. However, since their inception scientists have hypothesized about the risk of a clinically significant MAP-induced infection.
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