Abstract
Human ADME (Absorption, Distribution, Metabolism, and Excretion) studies of new chemical entities are an important part of the drug development process. These studies are normally performed by using a radioactive tracer (C-14 or H-3) blended with a therapeutic dose of non-radioactive drug in about four to six subjects. The radiolabeled API (Active Pharmaceutical Ingredient) is utilized to evaluate the recovery and track the metabolic fate and physiological disposition of the drug.
Highlights
Human ADME study (Absorption, Distribution, Metabolism, and Excretion) is an important and essential part of the drug development process
Human ADME (Absorption, Distribution, Metabolism, and Excretion) studies of new chemical entities are an important part of the drug development process
These studies are normally performed by using a radioactive tracer (C-14 or H-3) blended with a therapeutic dose of non-radioactive drug in about four to six subjects
Summary
Human ADME study (Absorption, Distribution, Metabolism, and Excretion) is an important and essential part of the drug development process. It is completed by using a radioactive tracer (C-14 or H-3) blended with the therapeutic dose of non-radioactive test drug. If human ADME studies are conducted in patients, we have to face difficult subject recruitment, limited options of clinical sites, preparation of radioactive drug for each patient, and a longer period of stability study for the radiolabeled API (Active Pharmaceutical Ingredient). If conducted in healthy volunteers, we will have relatively easier subject recruitment, more options of clinical sites, one batch preparation of radiolabeled drug for all subjects at the same time, and a shorter period of stability study for the radiolabeled API
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