Nonclinical safety evaluation generally includes a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure and, when appropriate, potential reversibility. Nonclinical safety studies, although usually limited at the beginning of clinical development, should be adequate to characterize potential adverse effects that might occur under the conditions of the clinical trial to be supported.

With over 25 years of experience in conducting nonclinical studies, you can rely on Altasciences for your program, and learn what preclinical criteria are needed to support your first-in-human clinical trials.

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Nanomilling is an effective, reproducible process that is extremely scalable.

One of the biggest benefits of nanomilling when compared to other formulation methods for poorly water-soluble APIs is its universality. While nanomilling is very useful for APIs with solubility below 200 µg/mL, it can easily be used for most insoluble APIs, making it an attractive, first-line method to solubilization. Altasciences is equipped with a state-of-the-art equipment train, including a Netzsch DeltaVita 15-300 Mill, for the wet milling of API.

Altasciences has decades of experience developing nanosuspensions from scratch. If you have an insoluble API, contact us to learn how nanomilling can be the solution you need.