How do you interpret bioequivalence results?
The currently accepted test is often called “bioequivalence”. The bioequivalence test states that we can conclude that two treatments are not different from one another if the 90% confidence interval of the ratio of a log-transformed exposure measure (AUC and/or Cmax) falls completely within the range 80-125%.
What is the significance of a bioequivalence study?
Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs.
What are bioequivalence studies?
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters.
Why bioequivalence studies are done?
What is the difference between bioequivalence and therapeutic equivalence?
Approved drug products are considered to be therapeutic equivalents if they are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
What is the clinical significance of bioequivalence?
Bioequivalence tests are very important role in the development of pharmaceuticals and match the accepted standard to ensure the therapeutic performance of drugs that have undergone changes in manufacturing processes, formulation modifications and also for the approval of generic drugs.
How many studies were designed as bioequivalence trials?
Three studies were designed as bioequivalence trials (1276.6, 1276.7, and 1276.8) and one study was designed as a bioavailability study (1276.5). Table19StudyCharacteristicsofBioequivalence andBioavailabilityStudies
What percentage of bioequivalence is required for narrow therapeutic index drugs?
These values meet the requirements for assuming bioequivalence as defined in the European Medicines Agency guidelines for narrow therapeutic index drugs (80%-125% for C (max) and 90%-111% for AUC). There were no relevant differences in the safety profiles of the test and reference formulations.
What is the bioequivalence design and evaluation document?
This document specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action. Read together with Appendix IV. How useful was this page? Please do not include any personal data, such as your name or contact details.
What is the purpose of establishing bioequivalence?
The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product.