PharmTech

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its ...
PharmTech

IVPT and Topical Drug Development: A Discussion on the Application and Importance of Using In-Vitro Permeation Testing as a Tool in Topical Drug Development

Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing IVPT during formulation development of novel topical compounds to help select excipients and permeation enhancers ...
RAPS

FDA releases new draft guidances on topical generic drugs

The US Food and Drug Administration (FDA) recently released several new draft guidances concerning topical generic drug products submitted under abbreviated new drug applications (ANDAs). The agency’s ...
Business Wire

FDA Draft Guidance on Acyclovir Enables Diteba's Novel IV Approach to Achieve Biowaiver Status, Replacing Clinical Trials

MISSISSAUGA, Ontario--(BUSINESS WIRE)--Diteba is pleased to announce it has developed a novel in vitro approach to qualify acyclovir cream products for biowaiver status in accordance with the recently ...