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 ?
Apotex did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505b2 application for Nurtec.
It expects to finalise its development and manufacturing agreements with a licensed cannabis producer/extractor to provide investigational pharmaceutical drugs, as well as initiate the requisite limited bioequivalence trial for market approval application early in 2020.
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.
About 10% of the applications were approved with one well-controlled clinical trial, including several topicals that were approved based on one bioequivalence trial with a clinical endpoint.
The company says its filing is based on the results its azathioprine pivotal bioequivalence trial. Azathioprine is marketed by Glaxo Wellcome as Imuran and by Roxane Laboratories as a generic.
Eton and its partner, Liqmeds Worldwide Limited, a United Kingdom-based pharmaceutical development and manufacturing company, expect to complete a bioequivalence trial in the second half of 2019 and, if successful, expect to file a New Drug Application with the FDA by the end of 2019.
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.
Sorrento plans to start a single bioequivalence trial required for registration in the Q1 of 2014.
A bioequivalence trial against Taxotere was not required.
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.
Bioequivalence trials of rifampicin containing formulations: Extrinsic and intrinsic factors in the absorption of rifampicin.