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A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
Pharmacological response data for comparative bioavailability studies of chlorpromazine oral dosage forms in humans:
Abstract:
Owing to the insensitivity of even the presently best chemical or radiological assay procedures, it is not feasible to perform comparative bioavailability studies of chlorpromazine oral drug products using blood or urine sampling; this is particularly the case for oral doses below 100-150 mg/70 kg. In contrast, the use of temporal miotic response data, which correlates with blood levels of unchanged drug, permits dose-response vs time profiles to be recorded with oral dose levels as low as 5-10 mg/70 kg. The monitoring of pupilometric data in up to 16 human volunteers demonstrated a sensitivity to both extents and rates of chlorpromazine bioavailability and revealed differences to exist between liquid and solid oral dosage forms of chlorpromazine.
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