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

Despite the continuous research on understanding how topical drugs and the skin interact,
the development of a topical generic product remains a challenge. Due to their local action …

The increasing demand for product and process understanding as an active pursuit in the
quality guideline Q8 and, more recently, on the draft guideline on quality and equivalence of …

EMA and FDA are upgrading guidelines on assessing the quality and the equivalence of
topically applied drug products for developing copies of originator products and supporting …

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

Abstract Purpose Following the recent European Medicine Agency (EMA) draft guideline on
quality and equivalence of topical products, a modular framework for bioequivalence …

Determination of bioequivalence remains a challenge in generic topical drug development.
To support pharmacokinetic studies, strategies to demonstrate microstructure sameness of …

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

The development of second-entry topical products is hampered by several factors. The
excipient composition should be similar to the reference product because excipients may …

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 …