FDA guidance gives IV approach biowaiver status

Using in vitro release rate and skin permeation testing, sponsors can implement a straightforward, compliant biowaiver study

The new guidelines could free developers of topical generic drugs from the burden of clinical trials

Nutrasource Diagnostics' global analytical and bioanalytical testing specialists, Diteba, has developed a novel in vitro approach to qualify acyclovir cream products for biowaiver status.

This is in accordance with the recently released FDA draft guidance on acyclovir.

The draft guidance allows in vitro release testing (IVRT) to be used in conjunction with skin tests using cadaver skin membrane.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 fully compliant approach combines acyclovir IVRT and in vitro skin permeation testing (IVPT) with the relevant clinical and statistical capabilities of Nutrasource’s regulated products division.

Many are saying this will be the future for all topical generic drugs.

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.

“This is great news for any company marketing topical pharmaceuticals,” said Neil Holman, Diteba’s Vice President of Marketing and Business Development.

“Utilising 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.”

Diteba 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.

“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 acyclovir cream and ointment studies. This draft guidance will lead to significant changes for many generic topical product developers.”

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