The skin is also the most exposed organ and is subject to several physical and environmental stressors.
The skin is involved in many functions, such as providing a protective barrier from the external environment (e.g., defending against microbial infection, inhibiting the entry of chemicals and toxins, preventing dehydration), regulating body temperature, and producing vitamin D. It covers the entire body and has a surface area of approximately 2 m 2 with thickness ranging from 0.5 to 4 mm or more. The skin is the largest organ of the integumentary system in humans. The review concludes with a discussion on drug product evaluation and quality tests as well as in vivo bioequivalence studies. The concept of utilizing in vitro skin permeation studies as a tool to justify formulation differences between the test generic product and the RLD to ensure a successful pharmacodynamic or clinical endpoint bioequivalence study is discussed. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3).
This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This review presents considerations which can be employed during the development of a semi-solid topical generic product.
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