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.

Altasciences’ clinical trial monitoring solutions will help progress your study from initiation to final close-out efficiently, while saving you time and costs. Our team of highly experienced, well-trained CRAs, will work with you throughout the conduct of your clinical trial to ensure strict adherence to protocol and regulations, subject safety, and accurate visit reporting.

Learn more about the benefits of working with Altasciences’ CRAs for your clinical trial monitoring needs.

At Altasciences, our integrated, full-service solutions from lead candidate selection to clinical proof of concept are all customizable to your specific needs.

Watch as Ingrid Holmes, Vice President, Global Clinical Operations, discusses how we help sponsors bring better drugs to market, faster.

Contact our experts to learn more about our integrated drug development solutions.