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FOOD AND DRUG ADMINISTRATION - page 124 / 263

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even within that broadly stated normal range of this assay used, might indicate subclinical hypo- or hyperthyroidism in individual patients.  These findings emphasize the ability of the serum TSH to provide a very sensitive reflection of the individual's pituitary and thyroidal axis status and point out the narrow target range that most individuals require for precise L-thyroxine treatment.

The adverse effects of over-dosage or under-dosage of thyroxine are outlined here, and as they've already been alluded to, I will not dwell on them.

We performed a bioequivalency study in patients with hypothyroidism at physiologic doses because there were concerns at that point in time that there were inconsistent clinical outcomes resulting from either changes in Lthyroxine content or absorption characteristics.  Our study was conducted immediately after the 1982 reformulation of Synthroid and compared typical clinical outcomes after 6-week dosing periods with either Levothroid or Synthroid in a crossover study.

Although we detected no statistically significant differences in the total thyroxine and free

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