Release date- 21082019 - This is to inform the exchange that the Company's Bioequivalence
Facility located at Vadodara was inspected by US Food & Drug Administration (USFDA) between 12th August, 2019 to 15th August, 2019 and between 12th August, 2019 to 20th August, 2019 for a) Bioequivalence
Bioanalytical and b) Bioequivalence
Should licensing agencies consider user fees for post-market bioequivalence
testing of critical dose and narrow therapeutic index drugs?
However, generics manufacturers were required to demonstrate "bioequivalence
" with branded products by showing that the active ingredient in their product diffused into the human bloodstream in a manner similar to the branded product.
The aim of the present study was therefore to determine the bioequivalence
of RFP in FDC formulations compared with RFP in free combinations in healthy Chinese male volunteers.
"The final check of bioequivalence
depends on the confidence interval.
"Acorda's refusal to sell samples of Ampyra at market prices to Accord Healthcare for bioequivalence
testing is intended to, and will, thwart the entry to market of any competing products, thereby extending its monopoly power in the relevant market," Accord said in its complaint.
Health Canada has set stricter bioequivalence
requirements for a few drugs that are highly toxic or have a narrow therapeutic range.
But the Food and Drug Administration "has determined that this approach is no longer appropriate" to establish bioequivalence
and "is revising its guidance to industry for how to conduct premarket bioequivalence
studies in generic bupropion products."
problem was confirmed in an FDA-sponsored study conducted in 2010, comparing the bioequivalence
of the Impax/Teva product to Wellbutrin XL 300 mg in 24 healthy adults, which determined that the generic tablets "fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg," according to the statement.
The study was designed as a randomized, controlled, 3-arm open-label, cross-over Phase I study to demonstrate the bioequivalence
of Phoslyra to PhosLo Gelcaps in healthy subjects.
Thus, regulatory authorities and medical prescribers would have the scientific support to expect a therapeutic equivalence if bioequivalence
among the compared pharmaceutical forms is demonstrated.
As it is known, drugs with proven bioequivalence
are reliable and inexpensive alternative drugs-brands and provide treatment required for all (Meshkovskii, 2003; Belousov, 2003; Panyushin, 2003).