About
The first Clinical Center for Bioequivalence, on the basis of which it is planned to conduct the clinical and biopharmaceutical parts of a clinical trial and provide manufacturers a full range of bioequivalence services, therapeutic equivalence, biowaiver studies within the EAEU at below market prices.
Kazakhstan’s 1st accredited Full Service CRO for bioavailability/bioequivalence
- Providing a Self-sustaining Clinical Research ecosystem
- Enabling Market Authorization beyond the EAEU
Bioequivalence study of a medicinal product is a type of clinical trial of a medicinal product which is carried out to determine the rate of absorption and excretion of the pharmaceutical substance, the amount of the pharmaceutical substance reaching the systemic circulation, and the results of which allow to conclude that the reproduced medicinal product in a certain dosage form and dosage corresponds to the original medicinal product.
Bioequivalence (pharmacokinetic equivalence) is the degree of similarity of a pharmaceutically equivalent drug in relation to the reference drug (usually a generic to the original patented drug). Determined experimentally, in vivo. The main criteria for bioequivalence are the degree and rate of absorption of the drug, the time to reach the maximum concentration in the blood and its value, the nature of the distribution of the drug in the tissues and body fluids, the type and rate of excretion of the drug.
Bioequivalence is established by certified pharmacological centers in studies involving healthy volunteers.
Bioequivalence studies provide sufficient efficacy and safety of a «quality generic» comparable to the quality of the original drug.
There are several types of drug equivalence:
— Pharmaceutical. Investigational products are considered pharmaceutically equivalent if they have the same qualitative and quantitative composition of the active substance, are used in the same way and meet the same standards. However, when using the drug only for pharmaceutically equivalent indications, it can lead to unintended therapeutic results.
— Therapeutic equivalence. Investigational medicinal products will be considered therapeutically equivalent if, when taking the same molar doses of the generic and the reference, the same clinical (therapeutic) effect occurs and the safety criteria for the drugs are the same.
Pharmacokinetic equivalence is also distinguished. This is a comparative analysis of the degree of coincidence of the pharmacokinetics of the generic and the original drug. The degree of absorption, metabolism, time to reach the maximum concentration in the blood, presence in organs, excretion from the body are assessed.
Only taking into account the objective, processed results of all studies, it is possible to make a conclusion about the bioequivalence of the drug.
Methods used to assess equivalence:
• Comparative pharmacokinetic studies
• Comparative clinical trials
• Comparative in vitro tests
• Comparative pharmacodynamic studies
The purpose of bioequivalence confirmation is to prove the equivalence of a generic medicinal product to a reference medicinal product in terms of quality in order to extrapolate the results of preclinical trials and clinical studies conducted in relation to the reference medicinal product to the generic product.
• in vivo comparison in volunteers which serve as an in vivo dissolution model
• biological quality control
• comparison of the characteristics of drugs in order to prove therapeutic equivalence
If bioequivalence cannot be confirmed by a bioavailability study, pharmacodynamic or clinical studies are performed.
Biowaiver: A procedure for assessing the bioequivalence of a generic medicinal product without an in vivo study.
Bioequivalence studies can be carried out by organizations that have all the necessary base and specialized conditions for the implementation of this type of work.
All work for drug research must be carried out in accordance with national legislation and accepted international standards.
13 main principles of GCP according to ICH
1. Clinical research must be conducted in accordance with ethical principles.
2. Before starting a study, the foreseeable risks and disadvantages must be considered against the expected benefits.
3. The rights, safety and health of study participants are the most important issues.
4. The available information about the test product must be sufficient to conduct a clinical study.
5. Clinical studies must be evidence-based.
6. The study must be conducted in accordance with a protocol previously approved by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
7. The medical care provided to participants and the choice of medications must always be the responsibility of a qualified physician.
8. Each person involved in the conduct of the study must be qualified to perform the assigned task
9. Voluntary informed consent must be obtained from each participant before starting a clinical trial.
10. All information about the clinical trial must be recorded, processed and stored.
11. The confidentiality of dossiers that could identify participants must be maintained by respecting the rules of secrecy and confidentiality.
12. Test products must be manufactured, processed and stored in accordance with the application of Good Manufacturing Practices (GMP).
13. Systems of procedures should be in place to ensure the quality of each aspect of the study.
