Posted by SalArmy4me on June 2, 2001, at 23:22:11
In reply to Heard they are taking Synthroid off the market , posted by lissy on June 2, 2001, at 20:19:34
Dong, Betty J. et al. "Bioequivalence of Generic and Brand-name Levothyroxine Products in the Treatment of Hypothyroidism" JAMA. 277(15):1205-1213, April 16, 1997:
"Results: No significant differences between the 4 products were found in area under the curve or peak serum concentrations of total thyroxine, total triiodothyronine, or free thyroxine index. Although Synthroid produced a more rapid rise in total serum triiodothyronine concentration and a higher total peak serum triiodothyronine concentration than the other products, these differences were not statistically significant (P=.08). The FDA criterion for relative bioequivalence within 90% confidence intervals (0.8-1.25) was demonstrated (P< .05) for all pairs of products. Relative bioequivalence of 0.95 to 1.07 was demonstrated, tighter than the current bioequivalence criterion for oral formulations."
"The 4 generic and brand-name levothyroxine preparations studied are different but are bioequivalent by current FDA criteria and are interchangeable in the majority of patients receiving thyroxine replacement therapy."
JAMA.1997
poster:SalArmy4me
thread:65205
URL: http://www.dr-bob.org/babble/20010530/msgs/65218.html