When to Switch Medications or Adjust Your Protocol Persistent anxiety after 4-6 weeks of stable dosing, or anxiety that worsens despite dose reduction, signals a need for treatment modification
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Jeffery et al., 2012
FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data
Plasma taurine concentrations in normal dogs and in dogs with heart disease, Journal of Veterinary Internal Medicine 9 (4): 253-258