Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.
To successfully develop a therapeutic drug one needs to understand, in addition to the choice of target and indication and the segment of patients to treat. One needs to understand what the drug does to the patient (toxicological) and what the patient would do to the drug (metabolism and clearance). Preclinical development, utilizing relevant animal models, attempts to clear the later points.
In this webinar, we will discuss strategies needed to successfully develop a drug followed by a brief discussion of the stages of drug development and the functional groups associated with each of the three stages. We will demonstrate that preclinical development is a stage that spans the entire drug development phase.
Preclinical development activities start at discovery to help candidate selection, determining the safety of the drug and determining the therapeutic doses as well as calculates the first in human dose. Preclinical and nonclinical activities do not end when the drug enters clinical studies but continues until marketing or even after that.
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