As the dose of 100 mg/m2 Schedule A resulted in manageable toxicities
and a dose intensity (75 mg/m2) approximately twice that of previously tested schedules, Kosan and Roche have recommended that it be further evaluated in the upcoming Phase II studies.
Side effects and toxicities
will likely return if you restart the same drugs).
On November 9 Boehringer Ingelheim Roxane Laboratories notified medical professionals that the FDA-required labeling for its drug nevirapine had strengthened its warnings about risks of liver and other toxicities
, due to reported cases of serious or fatal reactions to the drug.
Historically, risk assessment focused on adult exposures and toxicities
and gave little consideration to vulnerable life stages such as fetal development and early childhood.
Especially with acute toxicities
, multiple morphological diagnoses can be accurate and convey essentially the same information, and yet use different terms.
If such biomarkers can be established for processes such as hepatotoxicity, the approach may provide a strong stimulus for the search for biomarkers for other tissue- and organ-specific toxicities
such as vasculitis, cardiotoxicity, and cancer, for which surrogate models provide poor predictive power.