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Dose Inconsistency

Meaning

Dose Inconsistency is a critical quality control failure in pharmaceutical preparation, specifically defining a significant deviation between the labeled or prescribed amount of an active pharmaceutical ingredient and the actual amount contained within the final dosage unit. This variance can lead to unpredictable and potentially harmful therapeutic outcomes, ranging from sub-therapeutic effects, where the patient receives too little active hormone, to potential toxicity, where the dose is excessive. It is a major safety concern in compounded hormonal medications, as it fundamentally undermines the precision required for individualized endocrine management and compromises the reliability of the therapeutic regimen.