Quantifying how patients are actually exposed to a substance — the real-world numbers every safety margin depends on.
Exposure Assessment quantifies the extent and route by which patients or users are exposed to a pharmaceutical substance or impurity, taking into account dosage, frequency, duration of treatment, and route of administration — oral, dermal, inhalation, and more.
This step establishes the real-world exposure levels that will be compared against toxicological thresholds to determine safety margins.
Quantifying real-world treatment patterns.
Assessing exposure risk by oral, dermal, or inhalation routes.
Accounting for the specific population using the product.
Comparing exposure levels against toxicological thresholds.
Collecting dosage, frequency, and treatment duration information.
Real-world exposure is modeled by route of administration.
Exposure levels are compared against toxicological thresholds.
A documented safety margin conclusion is delivered.
Quantified real-world exposure levels for your patient population.
A clear safety margin calculation against toxicological thresholds.
Documentation ready to support your Toxicological Risk Assessment.
Direct access to the assessment team for follow-up questions.
Talk to our regulatory and scientific experts today.
Assign a Session