What is a Bioequivalence Study?
A BE study is a type of clinical study conducted to compare two medicinal products containing the same amount of the same active ingredient(s), in the same dosage form that meet the same or comparable standards but produced by different pharmaceutical companies. This clinical study examines scientifically if the two medicinal products will give rise to the same blood-level concentrations in a human subject at specific interval after consuming orally the two different products. A complex pattern of tasks and procedures are involved during this clinical study.

What happens during the BE trial?
Adult volunteers who are medically fit and had passed certain inclusion and exclusion criteria are recruited by the principal investigator for a BE study. A minimum 12 volunteers must be recruited for a BE study. The most common study design is 2-way cross over, double blind and randomised study- 2 products, 2 sequences, 2 periods. (so that the treatment effect can be distinguished and other variability/bias can be minimized)

At Visit 1: All participating volunteers must undergo a full medical check-up by a certified medical doctor before the study. Healthy volunteers who have passed the inclusion and exclusion criteria will be selected at this screening process. Then the principal investigator will explain to the volunteers the experimental aspects of the research, the purpose, the procedures involved, the foreseeable risks and other important elements of informed consent. After that, an informed consent agreement will be obtained from each willing participating volunteer.

At Study Period 1: All volunteers will stay for one or more days in the study wards. The volunteers will take one dose of the medicinal product (either Brand A or Brand B) and allow the clinical research team to collect their blood samples at specific time intervals. Doses are administered under close supervision and in a randomised method. After this is completed, the subjects will return home.

At Study Period 2: After a period of wash-out determined by the principal investigator, the volunteers will check into the study ward to repeat the same procedures as in Study Period 1 but with a different Brand product (which they did not take during the first study period). The blood samples collection will be repeated at the same specific time intervals.

At Visit 4: All the volunteers are required to come back to the study ward for a brief follow-up session one week after Study Period 2. This is to ensure the volunteers are healthy and are not adversely affected by the medicinal products.

After the completion of the clinical phase, all the collected blood samples from Study period 1 and 2 will be send to a pharmacokinetics laboratory to conduct the concentration analysis phase. This analytical phase will determine whether the two medicinal products are Bioequivalent or not.

How do we know if the BE trials are reliable?
The Malaysian government has strict guidelines (Malaysian Guidelines for Good Clinical Practice) and safeguards to ensure that all BE Centres are recognised and professionally run by medical staff. All BE Centres are audited regularly and accredited by NPCB. The investigators (e.g., USM, Gleneagles) must have appropriate expertise, qualifications and competence to undertake such a proposed study. Moreover, all BE Centres are require to retain ISO 17025 as a standard quality management and fulfill all Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) set by ICH, FDA and Drug Control Authority Malaysia (DCA)

Pharmaniaga BE Products
With over 300 products granted regulatory approvals, we have assumed the leading position in advocating clinical bio-equivalency (BE) studies in Malaysia. With BE studies, a bioequivalent Pharmaniaga product is clinically proven and interchangeable with the innovator product. This will provide additional assurance on the quality and efficacy of Pharmaniaga products as compared to the patented innovators. Doctors and consumers are able to switch brands confidently without any doubt of the efficacy and safety of our generics.

To view a listing of BE Study Centers, click here

To view a listing of our BE Products, click here