Therapeutic monitoring, often referred to as Therapeutic Drug Monitoring (TDM), is the clinical practice of measuring specific drug concentrations in a patient’s systemic circulation at designated intervals to optimize individual dosage regimens. This process is essential for drugs with a narrow therapeutic window, high toxicity, or unpredictable pharmacokinetics, ensuring that drug levels remain within the range that maximizes efficacy while minimizing the risk of adverse effects. In hormonal health, TDM is crucial for titrating replacement therapies to achieve physiological concentrations and avoid over- or under-dosing.
Origin
This clinical practice originated in the mid-20th century with the development of assays capable of accurately measuring drug concentrations in biological fluids. The concept is a cornerstone of personalized medicine, moving beyond standard dosing to individualized, evidence-based regimens.
Mechanism
The mechanism involves a cyclical process: the prescriber orders a dose, the patient takes the medication, and a blood sample is drawn at a critical time point, such as trough or peak concentration. The measured concentration is then compared to the established therapeutic reference range for that specific hormonal agent. This data allows the clinician to adjust the dose, frequency, or route of administration to achieve the desired clinical and biochemical endpoint, thereby ensuring the hormonal intervention is both safe and maximally effective for the individual patient.
The clinical evidence for compounded bioidentical hormones is limited, as they are not required to undergo the same rigorous FDA testing for safety and efficacy as manufactured drugs.
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