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 ?
Corium is in the process of evaluating the optimal path forward based on this feedback, taking into consideration that dosing in Corium's pivotal bioequivalence trial has already been completed.
The first study is a Phase III trial of dolutegravir (SINGLE), conducted with dolutegravir and abacavir/lamivudine as separate pills, while the second is a bioequivalence trial of the fixed-dose combination of dolutegravir/abacavir/lamivudine when taken as a single tablet compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.
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 plans to start a single bioequivalence trial required for registration in the Q1 of 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
A bioequivalence trial against Taxotere was not required.
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.
In particular, the CRL noted that, based on inspections at clinical sites, the authenticity of the drug products used in the pivotal bioequivalence trial (Study 530-01) could not be verified, which placed the results of the trial into question.
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.
In other developments, Sciele Pharma has completed the initial review of the bioequivalence trial for its new Sular formulation.