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Diteba Develops IV Approach to Achieve Biowaiver Status

novel approach to qualify acyclovir cream products for biowaiver status, potentially replacing clinical trials

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By: Kristin Brooks

Managing Editor, Contract Pharma

Diteba 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in vitro approach to qualify acyclovir cream products for biowaiver status in accordance with the recently released FDA draft guidance on acyclovir.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 compliant approach combines Diteba’s extensive acyclovir in vitro release testing (IVRT) and in vitro skin permeation testing (IVPT) with the relevant clinical and statistical capabilities of Nutrasource’s regulated products division. This approach provides drug companies with the option to utilize biowaiver in ...

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