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“How quickly can we begin?”

“Is the availability of test subjects an issue?”

“What capabilities do you have?”

“Based on your expertise what endpoints do you recommend?”

“When will I get results and the report?”

Our clients at that point would have formulated a promising drug and completed preliminary studies, such as in-vitro studies, and established whether their drug is efficacious. However, most have not yet administered the drug to a complete, living, functioning system. Or if they have, they have been very limited, small studies. Their next step is to move forward towards compiling their Investigational New Drug (IND) application and its submission to the FDA. This is a scenario where Attentive can provide valuable assistance.

Our acute toxicology services typically include studies that are quick and simple. We will dose a test system and establish what kind of immediate effects the drug is having. Often, these are considered maximum tolerated dose (MTD) studies. We will generally administer three to four single doses, approximately 72 hours apart in an escalating manner, allowing us to observe the test system for any acute toxicity prior to the administration of the next dose. The main purpose of this type of study is to establish how much we can administer to the test system before we encounter dose limiting toxicity.

Our clients can be rest assured that Attentive is conducting their studies within our newly-expanded state-of-the-art facilities, and utilizing Industry Standard Integrated Preclinical Software to record their data throughout.

The next step toward the IND process is to increase the duration of the study using the dose levels established during the MTD study. These studies are typically around 7 to 14 days, and are what we call a dose range finding (DRF) study. During DRF studies we will typically administer a vehicle/placebo control or one of three dose levels (a low, middle and high dose) to the test systems once or sometimes twice daily for up to 14 days instead of just a single dose. This type of study is to evaluate any toxicity that may arise from repeated exposure and essentially mimics when a patient is prescribed a short-term medication.

When a client comes to us, it is important that they start their projects quickly to get their data as soon as possible. Thus, Attentive has made it a priority to set ourselves up as the organization our clients can trust to initiate their studies quickly and turn their data around right away. In the past year we devoted ourselves to a path that has allowed us to substantially increase our capacity. We doubled our existing facilities and increased our number of veteran team members and leadership. As a result, here at Attentive we can take on a project and bring it online within a couple of weeks – months ahead of the rest of the industry. Additionally, the actions our leadership have taken to preserve the availability of test systems over the last year has placed Attentive in a very beneficial position for our clients.

If you feel your project could benefit from the Attentive nature of our processes, we invite you and your team to come and see (in-person or virtually) our newly-expanded facilities and meet the experts who will be handling your project. We would love to take you on a tour and show you the Attentive way we work with our clients. Call us or email today to schedule your tour.