Although millions of people all over the world are now using generic meds for different medical conditions, very few people are actually aware of the term ‘bio-equivalence.’ Two drugs are known to be bio-equivalent when they ultimately produce equal plasma concentration of all ‘active ‘ingredients inside the human body. The overall clinical effect of two bio-equivalent drugs is nearly the same.
Federal regulations require pharmaceutical companies to manufacture generic versions of drugs that are bio-equivalent of their banded counterparts. In most cases, two sample drugs are administered to volunteers to find out if their clinical effects are same or not. Some of the common parameters studied in the process include –
1. The maximum concentration of plasma achieved.
2. Total time taken to achieve the maximum concentration.
3. Total fraction of the drug absorbed successfully by the body.
Not many people realize the fact that generic medicine should be used as a substitute for the innovator drugs only when they are bio-equivalent. Scientifically speaking, when two products are bio-equivalent, there is absolutely no reason why a patient shouldn’t for the cheaper alternative available.
It is important that patients not only consult good doctors but also educate themselves on the subject to avoid using products that not equivalent. Such products can often lead to higher or lower blood concentrations of a medication inside the human body, thereby leading to either toxicity or failure of the therapy.
The medical research fraternity has been debating the bioequivalence of various drugs a lot over the last years. The controversy is particularly about the bioequivalence of drugs that are that have a really narrow therapeutic index. In case of these drugs, even slight changes in blood concentration levels can lead to an altered therapeutic response or even an unexpected level of drug toxicity!
Federal regulations require pharmaceutical companies to manufacture generic versions of drugs that are bio-equivalent of their banded counterparts. In most cases, two sample drugs are administered to volunteers to find out if their clinical effects are same or not. Some of the common parameters studied in the process include –
1. The maximum concentration of plasma achieved.
2. Total time taken to achieve the maximum concentration.
3. Total fraction of the drug absorbed successfully by the body.
Not many people realize the fact that generic medicine should be used as a substitute for the innovator drugs only when they are bio-equivalent. Scientifically speaking, when two products are bio-equivalent, there is absolutely no reason why a patient shouldn’t for the cheaper alternative available.
It is important that patients not only consult good doctors but also educate themselves on the subject to avoid using products that not equivalent. Such products can often lead to higher or lower blood concentrations of a medication inside the human body, thereby leading to either toxicity or failure of the therapy.
The medical research fraternity has been debating the bioequivalence of various drugs a lot over the last years. The controversy is particularly about the bioequivalence of drugs that are that have a really narrow therapeutic index. In case of these drugs, even slight changes in blood concentration levels can lead to an altered therapeutic response or even an unexpected level of drug toxicity!