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Download our recent white paper and learn more about the recent December 2016, FDA draft guidance on acyclovir cream and its two options for BE assessment of the generic formulations: in vitro or in vivo study as a potential biowaiver.

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Alternative in vitro bioequivalence assessment for topical applied dermatology formulations

Alt In Vitro

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.

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Best practices for choosing an analytical laboratory

Choose a Lab

Learn which questions to ask–and what answers to look for–when considering an analytical lab.

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Corporate Capabilities Dossier

Corporate Capabilities

Download our corporate capabilities dossier to learn more about DiTEBA and our services.

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Challenges and Solutions: toxicity testing challenges for topically applied products

Challenges and Solutions

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.

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Developing PEG Protein Analysis Methods

Developing PEG

Our Chief Scientific Officer at DiTEBA, Dr. Theo Kapanadze, Ph.D., highlights promising analysis methods for PEGylated proteins in a new comprehensive report.

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