News & Events

Wednesday, May 27, 2026

From Clinical Endpoints to In Vitro Bioequivalence: Regulatory Evolution of Topical Generic Drug Approvals in the US and EU

The regulatory approach to topical generic drug development has changed significantly over the past decade. Traditional clinical endpoint studies, once considered the standard pathway for demonstrating bioequivalence, are now often viewed as costly, variable, and limited in their ability to detect formulation-driven differences.

Friday, May 15, 2026

In Vitro Permeation Test for Topical Generic Drug Development: Why Submissions Fail and How to Build Defensible Programs

As regulatory expectations for topical generic drug products continue to evolve, IVPT has become a central tool for supporting bioequivalence in ANDA submissions. But while IVPT can provide a more sensitive and scientifically meaningful alternative to clinical endpoint studies, successful execution requires more than simply following a protocol.

Monday, June 16, 2025

Redefining Bioequivalence for Topical Drug Products: The Case for In Vitro Methodologies in ANDA Submissions

As regulatory expectations continue to evolve, in vitro methodologies like IVRT and IVPT are rapidly becoming the preferred tools for demonstrating bioequivalence (BE) of topically applied generic drugs.

Wednesday, October 23, 2024

FDA Bioequivalence (BE) approval for the IVPT study conducted on Penciclovir Cream 1%

Diteba Inc. has received FDA Bioequivalence (BE) approval for the IVPT study conducted on Penciclovir Cream 1%. The IVPT method is an essential biowaiver tool for evaluating bioequivalence in generic dermal and transdermal products.

Friday, August 16, 2024

Nitrosamine Impurities in Pharmaceuticals: Ensuring Safety and Compliance

Nitrosamine impurities have been a concern within the pharmaceutical industry and by regulatory authorities worldwide since June 2018, when regulators were informed of the presence of N-nitrosodimethylamine (NDMA) in the angiotensin-II receptor blocker (ARB) medicine, valsartan (1).

Sunday, June 16, 2024

Bioanalysis in Drug Discovery and Development, and Diagnosis

Bioanalysis is crucial for assessing drug efficacy and safety throughout the drug development process. It enables researchers to make informed decisions and improve patient outcomes in the pharmaceutical industry.

Tuesday, March 26, 2024

New IVRT/IVPT eBook

This updated edition builds upon our previous publication by incorporating the latest industry guidelines from the US FDA and USP, along with our own practical experiences and direct communications with the FDA. It serves as a valuable resource designed to guide industry professionals through the complexities of IVRT and IVPT methodologies with contemporary insights and regulatory standards.