Levothyroxine: A black swan? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2017-11-27 21:35 (2203 d 07:43 ago) – Posting: # 18015
Views: 7,604

Hi David,

❝ There isn't any biological background that might explain this issue? Or problems during manufacturing?

No idea.

❝ This is really awkward... the CI and point estimate are far more "perfect" than I am used to see.

For this drug, not. The relative BA (against a solution) is ~100% and the variability low to moderate. Check out the NDAs and ANDAs at FDA’s site. You will find a lot of studies with similarly narrow CIs (even with much smaller sample sizes).

❝ In fact, in full replicate studies, I've seen reference drugs "performing" poorly when compared with single administrations of themselves...

Normal for HVD(P)s.

❝ Is the dose-toxicity so sensible for this drug that event the narrower limits does not apply in this case?

No idea.

❝ Did a quick search and haven't find any study reporting the dose-response of this drug

The FDA’s guidance gives this explanation:

FDA has concluded that levothyroxine sodium is a narrow therapeutic index (NTI) drug based on the following evidence:

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