To Apply Microdosing or Not? Recommendations to Single Out Compounds with Non-Linear Pharmacokinetics
article
Non-linearities occur no more frequently between microdose and therapeutic dose studies than in therapeutic range ascending-dose studies.
Most non-linearities are due to known saturable processes, and can be foreseen by integrating commonly available preclinical data.
The guidance presented here may support decision making on incorporating a microdosing study in drug development.
Most non-linearities are due to known saturable processes, and can be foreseen by integrating commonly available preclinical data.
The guidance presented here may support decision making on incorporating a microdosing study in drug development.
TNO Identifier
527199
Source
Clinical Pharmacokinetics(Published online 05 August 2015)
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