bioequivalence trial

bioequivalence trial

A mandatory trial, conducted under an abbreviated new drug (ANDA) trial filed with the FDA, based on 20 to 40 healthy subjects, to ensure that the 2 products being evaluated do not differ in safety and efficacy and compare the bioavailability when administered at the same dosages.

Examples, summary measures
A BT records pharmacokinestic measures, but does not assess, clinical improvement or lack thereof. In a BT, summary measures of the plasma concentration vs time profile are used to compare 2 formulations of a drug product; equivalence of area under the curve (AUC), maximum plasma concentration (Cmax) and time to maximum concentration (Tmax) summary measures, does not guarantee equivalence of the entire profile.
References in periodicals archive ?
Sorrento commenced the single Bioequivalence trial required for registration with the first patient dosing in March 2014.
Several studies of hypoglycemia in normal, healthy subjects support the frequency of hypoglycemia found in this bioequivalence trial,[15, 16,17, 18 and the number of measurements (155/2033) of hypoglycemia were within the expected ranges for normal healthy subjects as described in the literature.
The company says its filing is based on the results its azathioprine pivotal bioequivalence trial.
Today's announcement follows last month's successful pivotal bioequivalence trial results with yet another RedHill drug, RHB-102 for the prevention of nausea and vomiting in cancer patients.
Sorrento initiated the single bioequivalence trial required for registration, on March 31, 2014.
RedHill Recently Announced Successful Results in a Pivotal Bioequivalence Trial with Another Drug: RHB-102, for the Prevention of Nausea and Vomiting in Cancer Patients
Sorrento anticipates initiating the single Bioequivalence trial required for registration, in the first quarter of 2014.
For example, Phoenix uniquely offers the ability to perform population PK/PD modeling within a validated environment; the ability to build graphical workflows that can access third party tools such as R, PsN, Xpose, SAS, S-Plus and NONMEM; and the ability to build IVIVC correlations to optimize bioequivalence trial design, to name but a few.
Sorrento anticipates initiating a single Bioequivalence trial required for registration, in the first quarter of 2014.
Zogenix and its European partner, Desitin Pharmaceuticals, GmbH ("Desitin"), announced that Desitin has filed for European regulatory approval of SUMAVEL DosePro following the successful completion of a European pivotal bioequivalence trial.
While our near term clinical opportunity exists in a bioequivalence trial of Cynviloq(TM) beginning in 2014, this ADC technology acquired from Concortis will help maximize the potential of our G-MAB library and fuel our R&D pipeline over the long-term," said Henry Ji, Ph.
In other developments, Sciele Pharma has completed the initial review of the bioequivalence trial for its new Sular formulation.