We understand the needs of its clients and the importance of regulatory strategies in drug development. We provide reliable bioequivalence (BE) and bioavailability (BA) assay services -CRO- for biotech and pharma industry partners. GCC is Specialized in bioequivalence studies and expert in comparing approved drugs with generic drugs, the company provides high quality test data from highly qualified personnel in state-of-the-art facilities. We conduct all studies in accordance with Good Clinical Practice (GCP).

What is bioequivlance (BE) & bioavailability (BA) study?

The concentration of a drug’s compound that reaches the systemic circulation or the site of action is known as bioavailability.

The gastrointestinal tract is where the majority of pharmaceuticals and medications taken orally enter the bloodstream. The systemic circulation allows these drug compounds to then reach the site of action. Drugs’ bioavailability is evaluated by looking at the level of their active pharmaceutical ingredient (API) and any metabolites in their plasma or serum. The active ingredient release from drug compounds, as well as its absorption, distribution, metabolism, and excretion, are all influenced by the API concentration.

Maximum drug concentration in the systemic circulation (Cmax), time to reach this concentration (Tmax), and area under the time-drug concentration curve (AUC) are the three main pharmacokinetic study variables used to evaluate the bioavailability of drugs.

Two drug products are said to be bioequivalent if their bioavailability is comparable.

Why need bioequivalence study?

Bioequivalence studies make it possible to draw conclusions about the quality of compared drugs based on a much smaller amount of primary information and in a shorter time than in full-scale clinical trials. Terms of bioequivalence studies: from setting the task, drawing up a bioequivalence study program to obtaining the results of the study, drawn up in the form of a report, takes about a month. The cost of bioequivalence studies is significantly lower than the cost of conducting full-scale clinical trials. Financing of bioequivalence studies is more often undertaken by either the manufacturer of the drug, or the company that decides to register this drug for the purpose of further sale.

How bioequivalence Study conducted?

Bioequivalence studies are carried out in accordance with the program, which is submitted to the Commission on Clinical Pharmacology and Ethical Aspects of the FGC. After approval by the commission, the program is approved by the FGC. The program should reflect the place of testing, information about the study drugs, information about the subjects, their number, randomization plan, doses and dosing regimens of drugs, biomaterial in which it is supposed to determine the concentration, sampling scheme, information about the analytical method, main pharmacokinetic parameters, methods for calculating pharmacokinetic parameters and statistical processing of the data obtained. A study on the bioequivalence of a generic and a reference drug is carried out in the same dosages. If several dosage forms of the same drug are applied for registration,

The time interval between taking the study drug and the reference drug (the “washout” period) depends on the duration of the circulation of the drug in the body, is determined by the half-life (T1 / 2) and should be at least 6 T1 / 2. The biological material used to determine the concentration of a drug can be plasma, serum or whole blood. Blood is taken from the cubital (usually) vein through a cubital catheter. Sampling tubes should be appropriately labeled with the test code, sample number, and drug name. The frequency of sampling from the subject is determined by the shape of the curve “drug concentration – time” of the reference drug.

The total duration of monitoring the concentration of the drug in the systemic circulation with a single dose should be at least 4 half-lives of the studied drug.

The duration of observation is considered acceptable if, for the averaged pharmacokinetic profile, the area under the concentration-time curve, ranging from zero to the time of the last sample collection, is at least 80% of the area, ranging from zero to infinity.

Requirements for conducting bioequivalence Study

After the manufacturer has decided to register the medicinal product, the State Pharmacological Committee (FGK) of the Ministry of Health of Russia decides on the need to conduct bioequivalence studies of the presented drug in comparison with the registered and well-known drug at the same doses on healthy volunteers or, in some cases, patients who the study drug is indicated (oncological, HIV-infected, drug addicts, etc.). The customer provides funding for the ongoing research (payment for volunteers, researchers, insurance policy).

Such studies are carried out in licensed pharmacokinetic laboratories or centers that are technically seriously equipped and have well-trained scientific personnel who own modern methods for analyzing drugs in biological objects, in medical institutions licensed to work with healthy volunteers. As a rule, the study is carried out on 10-30 healthy volunteers.

Healthy volunteers may be of both sexes between the ages of 18 and 55. The body weight of volunteers should not deviate by more than 20% from the ideal body weight.

It is prohibited to conduct bioequivalence studies in minors, pregnant and lactating women, in persons suffering from chronic diseases of the cardiovascular and neuroendocrine system, liver, kidneys, in persons suffering from allergic diseases, drug addiction, alcoholism (except when the study drug is indicated for this particular group of patients).

Importance of bioavailability and bioequivalence

Why choose GCC for your bioequivalence and bioavailability studies?

With similar therapeutic and side effect profiles, bioequivalence establishes generic drugs as interchangeable with branded drug compounds. Drugs’ bioavailability refers to how quickly and thoroughly their active ingredient is absorbed into the body after dosing. In order to expedite regulatory submission and drug approval applications like IND, BLA, ANDA, and NDA, NorthEast BioLab performs regulated analysis for your bioequivalence and bioavailability studies.

To assess the bioavailability and bioequivalence of your drugs, our scientists and lab analysts develop and use reliable bioanalytical methods. For instance, we regularly comply with the FDA’s and other regulatory agencies’ requirements for Incurred Sample Reanalysis (ISR) for all of our bioequivalence studies in order to demonstrate the accuracy and repeatability of your data.

20+ years of bioequivalence experience.