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Therapeutic Drug Monitoring: Affecting Factors

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.

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Leveraging Turbidity and Thromboelastography for Complementary Clot Characterization

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Monitoring Compound-Related Effects on Coagulability in Rats and Cynomolgus and Rhesus Monkeys by Thrombin Generation

F Poitout-Belissent¹, D Culang², D Poulin¹

¹Charles River Laboratories, ULC, Senneville, Canada.

International Journal of Toxicology

|March 11, 2020

Summary

This summary is machine-generated.

The thrombin generation assay (TGA) is validated for nonclinical studies in rats and nonhuman primates. This sensitive method accurately measures coagulation potential in vitro and in vivo.

Keywords:

anticoagulant heparin lipopolysaccharides nonhuman primate rat thrombin generation assay tissue factor

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Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay

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Published on: September 9, 2012

Area of Science:

Coagulation science
Pharmacology
Toxicology

Background:

Thrombin generation assay (TGA) assesses plasma clotting potential.
It detects hypocoagulable and hypercoagulable states.
TGA is crucial for understanding coagulation dynamics.

Purpose of the Study:

To validate the TGA for nonclinical in vivo and in vitro studies in nonhuman primates (NHP) and rats.
To establish TGA's utility in drug development and toxicological assessments.
To ensure reliable measurement of coagulation parameters in preclinical models.

Main Methods:

Blood was collected from nonanesthetized rats and NHP, processed into platelet-poor plasma.
Thrombin generation was analyzed using TGA with 5 pM tissue factor, achieving <10% CV.
In vitro studies involved UFH, tissue factor, and anticoagulant compounds; in vivo studies used a rat LPS inflammation model.

Main Results:

TGA demonstrated dose-dependent responses to unfractionated heparin, tissue factor, and anticoagulants in vitro.
In rats, lipopolysaccharide administration decreased thrombin generation, with peak thrombin-antithrombin complexes observed earlier.
Assay precision (CV <10%) supports reliable thrombin generation measurement.

Conclusions:

TGA is suitable for in vitro screening of compounds affecting the coagulation cascade.
Thrombin generation can be reliably measured at interim time points in nonclinical in vivo studies.
Validated TGA provides a robust tool for preclinical coagulation assessment in NHP and rats.