A bioequivalence study is considered critical by contract research organizations to create large return on investment in predicting the efficacy, reliability and safety of the drug compound.
Medicinal drugs are essential to human health. They allow people with disorders to fight the disease and lead healthy lives as much as possible. A bioequivalence study establishes that a generic or test drug (undergoing research and development) offers the same level of safety and effectiveness as a branded or in-market or referenced drug. The drugs are made available for human consumption, once their bioequivalence is suitably established and the bioavailability of the drugs is proven.
Let’s look at some of the key factor that CROs consider for bioequivalence studies:
1. Creating Study Design– The two most commonly used designs are parallel or crossover. In both the studies, volunteers are divided into two groups. The difference lies is in the provided dosage. In parallel study, both groups get the same treatment from the beginning until the end. In crossover study, the tested and referenced drugs are interchanged between groups to determine how the treatment progresses. It gives scientists a clear idea of whether the test drug and referenced drug have the same efficacy. If the efficacy remains the same, it means the bioavailability of the drugs is established.
2. Number & Selection of Subjects– Given the focus on genetic history, the number and selection of the subjects is an essential consideration. The number of test subjects is standardized as per acceptable procedures to minimize intra and inter variations. Most clinical trials use adults over the age of 18 years, and the choice of gender and age varies as per the requirement of bioequivalence study.
3. Drug Administration– This involves studying the absorption, distribution, metabolism, and excretion of a drug compound. The PK studies take into account how the drug compound reacts with the body’s analytes and their efficacy for trials involving human volunteers. It is a crucial step to create the right dose regimen for all populations.
4. Measuring Biological Samples– The concentration levels of the drug compound are an effective indication of the drug’s psychochemical properties. These properties help measure formulations, route, etc that are critical to establish bioequivalence.
5. Sampling Bodily Fluids– Dosage form of the drug compound is measured in body fluids such as blood and plasma to judge the changes in concentration. There is bound to be loss of chemical and physical properties as the drug compound travels from one location to another, and the concentration levels in biological fluids help determine the right level needed at the final site of action.
6. Determining Endogenous Compounds– The organic tissue have compounds with the similar chemical and biological markup as that of the drug compound that is being tested. It, therefore, becomes critical to test the interaction between the two and determine the level of the compound’s concentration. It may be a difficult and time-consuming task, but one that needs to be considered at all costs.
Pharma companies usually depend on contract research organizations such as bioanalytical labs, with the required experience and expertise, to establish bioavailability of the drugs.