FDA Draft Guidance on Acyclovir Enables DiTEBA’s Novel IV Approach to Achieve Biowaiver Status, Replacing Clinical Trials

March 30, 2017

Mississauga, Ontario, March 30, 2017 (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in vitro approach to qualify acyclovir cream products for biowaiver status in accordance with the recently released FDA draft guidance on acyclovir.

This fully compliant approach combines the extensive acyclovir in vitro release testing (IVRT) and in vitro skin permeation testing (IVPT) expertise of DiTEBA with the relevant clinical and statistical capabilities of Nutrasource’s regulated products division. This approach provides drug companies with the optimal chance of biowaiver success in lieu of the high cost and long delivery times associated with human clinical trials.

A global leader in complex analytical and bioanalytical testing, DiTEBA specializes in IVRT and IVPT and provides method development and validation of release rate studies for topical formulations including creams, lotions, ointments, gels, pastes, less viscous solutions and suspensions and transdermal patches for both product development and regulatory purposes.

The draft guidance, issued Dec. 28, 2016, allows IVRT, a measure of release of the active pharmaceutical ingredient from the drug product matrix in a controlled laboratory environment, to be used in conjunction with skin tests using cadaver skin membrane. The FDA has accepted results of this method as comparable to traditional clinical trials, potentially saving sponsors millions of dollars in product development.

“This is great news for any company marketing topical pharmaceuticals,” said Neil Holman, DiTEBA's vice president of marketing and business development. “Utilizing in vitro release rate and skin permeation testing, sponsors can implement a straightforward, compliant biowaiver study, avoiding costly and time-consuming clinical trials. Many are saying this will be the future for all topical generic drugs, which should lower costs and speed approvals.”

“IVRT and IVPT have been widely used techniques for decades, broadly accepted in a variety of topical and semi-solid analytical applications,” said Theo Kapanadze, co-founder and chief scientific officer of DiTEBA. “We have a great deal of experience in this, including acyclovir cream and ointment studies, and believe this draft guidance will lead to significant changes for many generic topical product developers. We’re looking forward to helping them apply it in their development programs.”

About DiTEBA
DiTEBA is a global leader in complex analytical and bioanalytical testing, specializing in in vitro release testing (IVRT), to the biopharmaceutical and generic industries. For a full list of DiTEBA testing services, visit our About page.


Back to News