Posted by ed_uk on March 29, 2005, at 17:11:51
In reply to We don't like generics.........., posted by ed_uk on March 29, 2005, at 16:55:05
Biopharm Drug Dispos. 1989 Nov-Dec;10(6):597-605.
Bioinequivalence of a generic brand of diazepam.
Locniskar A, Greenblatt DJ, Harmatz JS, Shader RI.
Department of Psychiatry, Tufts University School of Medicine, Boston, Massachusetts.
Twenty-six healthy male volunteers received a single 10 mg dose of diazepam on two occasions in a crossover bioequivalence study comparing the reference product (Valium) and a generic formulation (NeoCalme). Concentrations of diazepam and its metabolite, desmethyldiazepam, were determined during 264h after each dose. Peak plasma diazepam concentrations were significantly lower for NeoCalme vs Valium (247 vs 394 ng ml-1, p less than 0.001) and reached significantly later after the dose (1.62 vs 0.98 h, p less than 0.001). Total area under the plasma concentration curve (AUC) was also significantly lower for NeoCalme (6614 vs 7552 ng ml-1 x h, p less than 0.001), although AUC ratios for NeoCalme divided by Valium satisfied the '75-75' guidelines. Findings for desmethyldiazepam were similar. Thus, diazepam absorption from the generic brand of diazepam is significantly slower than from Valium, which in turn could lead to therapeutic inequivalence.
poster:ed_uk
thread:477325
URL: http://www.dr-bob.org/babble/20050326/msgs/477331.html