In Vitro Alternative Based Approaches for Bioequivalence (BE) Assessment of Generic Topical Dermatological Products
Download our recent white paper and learn more about the recent December 2016, FDA draft guidance on acyclovir cream and its two options for BE assessment of the generic formulations: in vitro or in vivo study as a potential biowaiver.
Carrying out bioavailability/bioequivalence studies for semisolid drug products has been a challenge historically. This whitepaper describes how DiTEBA's standardized in vitro bioequivalence testing protocol can be used as a valid alternative to conventional in vivo approaches.
Learn which questions to ask–and what answers to look for–when considering an analytical lab.
Download our corporate capabilities dossier to learn more about DiTEBA and our services.
There is an increasing need for alternative dermal toxicity testing approaches that are at least as good as animal tests and potentially more cost-effective. This whitepaper describes key challenges facing the pharmaceutical and cosmetics industry, along with solutions on how to overcome common industry challenges.
Our Chief Scientific Officer at DiTEBA, Dr. Theo Kapanadze, Ph.D., highlights promising analysis methods for PEGylated proteins in a new comprehensive report.