bioequivalence bioavailability study in eastern europe bulgaria

BE/BA TIMELINES BE/BA CTA DOCUMENTS  

BE/BA SERVICES BE/BA STUDY BUDGET

 

Convex team has extensive experience in the conduct of bioequivalence and bioavailability study. We can work along with you in the process of a study design and conduct of: 

  • Crossover and Parallel Design
  • Single Dose and Multi Dose
  • Healthy Subject and Patient Population
  • Administered Dose
  • Sampling
  • Parent Drug and Metabolites
  • Enantiomers and Racemates
  • Endogenous Compounds
  • Food-Effect BA study
  • Fast Fed BE study
  • Drug-drug interaction studies

 

We have been involed in studies examinig the bioequivalence between: 

  • Highly Variable Drugs
  • Liposamoal Drug Products
  • Drug Products Acting Locally
  • Topical Drug Products
  • Orally Inhaled Drug Products- powder inhalers and metered dese inhalers 
  • Nasal drug products

 

BE studies play an important role in the drug development as well as during post-approval period for both pioneer and geeric dug. The main objectives of these studies may be twofold. They serves as bridging studies in the pesence of formulation or manufacturing changes to provide supportive evidence for safety and effiacy of a drug product. Also they can utilized to assure product quality and performance throughtout the life time of a drug product. Two drug products are considered bioequivalent if they are pharmaceutical equivalent or pharmaceutical alternatives whose rate and extent of absorbtion  do not show a significant difference when administered at the same molar dose of the active moiety under similar experimential conditions, either single dose or multidose.

What is bioequivalence (BE)? The absence of a significant difference in the rate and extent to which an active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives become available at the site of action when administered at the same molar dose under the same conditions in an appropriately designed study. BE between a test and reference product is established in order to demonstrate therapeutic equivalence. Therapeutically equivalent drug products can be substituted with the full expectation that the substituted (test) product will produce the same safety effect and safety profile as the originally prescribed ( reference) product. Acceptable BE between a test and reference profuct is among the criteria by regulatory agency for approval of new generic drug product

What is bioavailability (BA)? The absense of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalence or alternatives becomes available at the site of drug action when administered at the same molar dose under similiar conditions in an appropriately designed study.

What is the difference between BE and BA? The difference between BE and BA lies in the study goals, hence the study designs and statistical analysis of the study outcomes. The BA studies can be employed to assess the pharmacokinetics and performance of a drug product related to the absorbtion, distribution and elimination of the drug in vivo. In contrast, BE studies  are premarily utilized for formulation comparisons and thus data analysis focuses on the release of active ingredient or moiety from the drug product and subsequent absorbtion into the systemic circulation. Drug profucts are considered as pharmaceutical equivalents when they are identical dosage forms and contain identical amounts of the identical active drug ingredient. These products do not necessarily contain the same inactive ingredients and they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, expiration time, and within certain limits labling. 

 

For more information please contact us at: info@convex.bg