Novel in vitro approach bypasses in vivo bioequivalence studies

05-Apr-2017 - Last updated on 06-Apr-2017 at 16:54 GMT

The new approach allows companies to obtain biowaivers for acyclovir cream without conducting in vivo bioequivalence studies. (Image: iStock/styf22)

Diteba has developed a novel in vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.

The FDA draft guidance on acyclovir was issued December 28, 2016 and allows in vitro release testing (IVRT) to be used in conjunction with skin tests using cadaver skin membrane.

Diteba, a Nutrasource Diagnostics Inc. company and contract research organization (CRO) providing analytical and bioanalytical testing services, said its new FDA-compliant approach provides drug companies with the “optimal” chance of biowaiver success in lieu of human clinical trials.

“To be fully compliant, the latest draft guidance for acyclovir cream not only requires the contract research organization (CRO) to have a high level of knowledge and experience with in vitro release testing (IVRT) and in vitro skin permeation testing (IVPT) methodologies, but also a thorough understanding of current clinical and regulatory practices,” Dr. Theo Kapanadze, Chief Scientific Officer, Diteba, D.Sc., Ph.D, told Outsourcing-Pharma.com.

Kapanadze also explained the CRO is combining its experience with Nutrasource’s regulatory strategy knowledge and clinical trials divisions in order to design clinical development plans.

“These factors provide our sponsors with the best expertise available to help them obtain biowaivers for acyclovir cream today and other topically applied generic formulations in the future, avoiding high-cost, time-consuming in vivo bioequivalence studies,” he added.

“Foremost, sponsors can avoid high-cost, time-consuming in vivo bioequivalence studies.”