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What Is This Protocol?

BioCelerate is developing a toxicology study protocol template meant for first-in-human enabling, 28-day repeat dose studies. The purpose of a common template is to facilitate efficiencies for CROs, sponsors and others involved in toxicology study execution or review. A common template has the potential to enable process and time efficiencies, minimize cost, and improve overall quality in the conduct of studies. Additionally, common templates across the study lifecycle can help promote end-to-end traceability and integrity of data, more streamlined study interpretation, and reuse of content.

Version 0.2 of the Protocol Template for Repeat-Dose Toxicology Studies is now available for review and feedback by the public. Version 0.2 is a working draft document updated based on feedback provided on Version 0.1.  As feedback and comments are key to a robust and well-accepted Template, we invite all stakeholders to submit feedback and comments on Version 0.2 to improve the Template for its first major release.

Feedback may be submitted using the Basic Feedback Form on this page.

If desired, you may also provide more detailed, section-specific feedback offline by downloading the Detailed Feedback Form here and emailing the completed form to info@biocelerate.org.

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