Novel IV approach developed may replace clinical trials

Diteba, a leader in complex analytical and bioanalytical testing, has developed an in vitro (IV) approach to qualify acyclovir cream products for biowaiver status in accordance with recently released FDA draft guidance.

The guidance issued at the end of last year, allows IV release testing (IVRT) — a measure of release of the API from the drug product matrix in a controlled laboratory environment — to be used in conjunction with skin tests using cadaver skin membrane. Results of this method have been accepted by the FDA as comparable to those achieved in traditional clinical trials.

“This is great news for any company marketing topical pharmaceuticals,” said Neil Holman, Diteba's vice president of marketing and business development. “Using in vitro release rate and skin permeation testing, sponsors can implement a straightforward, compliant biowaiver study, avoiding costly and time-consuming clinical trials.”

“We have a great deal of experience in this, including acyclovir cream and ointment studies, and believe this draft guidance will lead to significant changes for many generic topical product developers,” added Theo Kapanadze, co-founder and chief scientific officer of Diteba. “We're looking forward to helping them apply it in their development programmes.”