Due to complex interdependent relationships affecting their microstructure, topical semisolid
drug formulations face unique obstacles to the development of generics compared to other …

This review considers the role of in vitro permeation testing (IVPT) for the evaluation of drug
delivery from topical formulations applied to the skin. The technique was pioneered by Franz …

The series of conferences of the Global Bioequivalence Harmonisation Initiative (GBHI) was
started in 2015 by the European Federation for Pharmaceutical Sciences (EUFEPS). All …

Documenting topical bioequivalence can be an extremely complex process, which is
intrinsically dependent on the formulation technological features. According to EMA …

In recent years, the regulatory mechanisms for topical generic product bioequivalence (BE)
assessment have been subjected to noteworthy changes, with the FDA issuing product …

Allergic contact dermatitis (ACD) is the most prevalent occupational disease and the most
common form of immunotoxicity in humans. Preventing exposure to the triggering allergens …

Inter-and intra-batch variability of the quality attributes contribute to the uncertainty for
demonstrating equivalent microstructure of post-approval changes and generic/hybrids of …

The European Medical Agency (EMA) has issued a draft guideline on the quality and
equivalence of topical products. The equivalence for complex semisolid formulations …

Over the past decade, topically applied drug products have experienced extraordinary price
increases, due to the shortage of multisource generic drug products. This occurrence is …

Purpose In vitro release testing (IVRT) is an essential analytical method used to assess the
bioequivalence of semi-solid dosage forms, including topical creams, ointments, and gels …