Bioavailability
1. The rate and extent of drug absorption of unchanged drug from its dosage form into the systemic circulation.
2. Measured by the demonstrated bioequivalence studies of reference protocol.
3. Bioavailability is a comparison of the drug product to an IV formulation.
4. This studies are expletory
5. Evaluate geometric ratio but don’t test a statistical hypothesis
6. Not require a similar time to achieve peak blood concentrations.
7. Provide indirect information regarding the pre-systemic and systemic metabolism of the drug
8. Determined only which active ingredient or moiety become available in the site of action.
9. Provide useful information to establish dosage regimens and to support drug labeling, such as distribution and elimination characteristics of the drug
10. For example, if 100 mg of a drug are administered orally and 70 mg of this drug are absorbed unchanged, the bioavailability is 0.7 or 70%
Bioequivalence
1. Two or more similar dosage forms reach the systemic circulation at the same relative rate and extent.
2. Bioequivalence has been established via bioavailability testing.
3. Bioequivalence is a comparison with predetermined bioequivalence limits.
4. This studies are confirmatory .
5. Test a statistical hypothesis by evaluating geometric ratio.
6. Require similar times to achieve peak blood concentrations.
7. Provide a link between the pivotal and early clinical trial formulation.
8. Determined the therapeutic equivalence between the pharmaceutical equivalence generic drug product and a corresponding reference listed drug.
9. Provide information on product quality and performance when there are changes in components, composition and method of manufacture after approval of the drug product.
10. Example- a receptor in the brain - the brand name and the generic drug should deliver the same amount of active ingredient to the target site.
Have any more specific or important point of these differences?
Thanks Mr. Anoop Narayanan V for your answer and opinion...
As mentioned in the question, bioavailability is the rate and extent at which a drug enters into systemic circulation in its unchanged form.
If we simplify it is the measure of % of drug absorbed along with the speed of drug absorption. Say if a drug administered is absorbed completely (100%) but in a very slow rate, the bioavailability measured will be lower. A drug which gets absorbed faster but an incomplete absorption will also be referred to as a low bioavailable drug. For a drug to be highly bioavailable it should be fast and completely absorbable.
Bioequivalence is Just a comparison of the bioavailability of two identical products. For example, we compare two brands of paracetamol (Acetaminophen) for their bioavailability. If they show similar bioavailability they are called bioequivalent.
There is no logic in differentiating them, bioequivalence is calculated by measuring bioavailability of two products and comparing them.
Bioavailability of a drug is the proportion that can reach the circulation in its unchanged form (API) and have an active effect.
The bioequivalence is determined based on the bioavailability of two drugs (innovator and generic one) --> in other words by comparing the ratio of pharmacokinetic variables of one drug versus another (where equality = 1).
Thank you Dear Katia Sayyed for mentioning a specific point...
The rate and extent of absorption is called as bioavailability.
Bioequivalence is the comparison of bioavailability between two drug formulations.
Mr. Md. Khokon Miah Akanda ....This is more kind of an exam based answer which anyone can read and write or simply copy paste. The stated difference can be answered by anyone who has even very basic pharmacy knowledge. I answered the question keeping in mind that even some one from non technical background can understand it.
Anyway, thanks for the feedback.
Bio availability is the portion of administered drug that reaches the systemic circulation in a chemically unchanged form while bio-equivalence is the term used to describe or compare the bio availability of two drugs. Two drugs are said to be bio-equivalent if they take exactly the same time to achieve the same bio-availability and to reach steady state
Apart from the definitions stated previously, in the world of generic drugs their significance may be quite iniquable according to a country legislation. That means the bioequivalence between two drugs may have a range of acceptability that goes from 5 to 20%.
Mr. Atreyee Sarkar Definitely, I written this answer an exam based by studying relevant books and journal. But I asked here this question to know more from who have research experience or expert of this field. Thanks for cooperation...
Mr. Peter Mworozi Already mentioned this contend, have anymore specific point?
The proportion of drug or therapeutic substance available in blood circulation, after introduced to an organism,to produce the intended active effect.
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