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:
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 physicians and patients, bioequivalent drug products can and should be used interchangeably to achieve a similar therapeutic effect. Bioequivalence studies, in fact, serve as surrogates for clinical trials in evaluation of therapeutic equivalence in efficacy and safety between the innovator product and its generic copies. However, when a physician has the possibility of administering a generic drug product, he or she needs to consider the anticipated therapeutic effect that may be obtained from the patient. If a new patient has just begun a drug regimen, the physician does not have any information about the patient’s therapeutic response to any of the different formulation that he or she could prescribe. As a result, the only relevant information that the physician could have is the comparison of the marginal distributions for some pharmacokinetic responses or metric between the generic and innovator drug product from a population of subjects. If the marginal distributions follow an approximate normal distribution, the equivalence can be evaluated through inferences on population parameters, such as average and intrasubject variability. This concept is referred to as the population bioequivalence. Given the information about population parameters, the physician can determine whether to prescribe an innovator drug product or its generic copies to a new patient who just begins to receive the drug regime. On the other hand, suppose a patient with a chronic disease, such as hypertension or diabetes, has been well controlled under long-term administration of an innovator drug product. In other words, the concentration of its active ingredients has been titrated to an efficacious and safety level within the patient’s individual therapeutic window.
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