Bioavailability is the amount of drug that reached the main place of action in the human or animal body. This term denotes the number of lost and saved of nutrients that are beneficial to the body. Thus, with a high degree of bioavailability can be judged on a small number of lost therapeutic properties of any drug.
The standard forms of research the bioavailability of drugs is determined by a method of measuring the drugs in the blood, that is, the amount that reached the circulatory system. With different methods of introduction it has various indicators. So, with intravenous bioavailability approaching 100 %. And if you've had oral bioavailability, the volume is significantly reduced due to incomplete absorption and disintegration of the drug into its individual components.
This term is also used in pharmacokinetics to calculate the correct dosage to be followed to the patient when different methods of administration of the drug in the body.
There are two stages of bioavailability:
The Absolute bioavailability is the rate resulting from the comparative analysis of a drug's bioavailability, entered by anyone, except intravenous, method and availability of the drug, administered intravenously. It is reflected in the area under a curve "volume – time", abbreviated "SPC”. To carry out such a procedure is possible only when such conditions, as the use of various dosages of different methods of introduction into the body.
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To determine the number of absolute bioavailability, the conduct of pharmacokinetic studies, aimed at obtaining the comparative analysis of “the amount of medications in relation to time" for intravenous and other method of implementation. Thus, the absolute bioavailability of medicines - is the ACC for the altered dose, obtained in the course of dividing the PPK another method of injection and intravenously.
The relative bioavailability is the ACC of the drug subjected to comparison with another version of the same drug taken for a basis or introduced any other way. Foundation – intravenous route, characterized by the absolute bioavailability.
To obtain data on the number of relative bioavailability in the body are used as the indicators of the amount of drug in the circulatory system or in its excretion with urine after single or multiple applications. With the aim of obtaining a high percentage of accuracy when analyzing cross method of learning. It allows you to maximize to eliminate the difference between the results obtained in physiological and pathological conditions.
To determine the low bioavailability of the drug or high scholars, the following types of methods:
HPLC – another method of determining the bioavailability of – chromatography with high efficiency, used if necessary, the separation of complex substances to simple. Used most frequently in the study of bioavailability, as it has the following positive qualities:
The Standard amount of drug in the body Papademos devotional by equal less than 1. However, it may be even less because of some additional nuances. Thus, factors influencing bioavailability, is:
Another kind is the bioavailability, bioequivalence is. Originated this concept in connection with the conduct of pharmacokinetic and bioformation studies in which it was revealed that the inequality of the therapeutic drugs containing the same substance, has a direct correlation with the difference in bioavailability.
Thus, bioequivalence – is ensure the blood and tissue of the body the same number of substances.
To determine bioequivalence in drugs are used the following indicators:
Before starting the preparation is on sale, you should examine the bioequivalence and bioavailability of drugs is very important. To that end the following procedure:
This procedure is Carried out in special medical institutions or laboratories involving third-party experts. The selection of candidates for research must respect the following requirements:
Before signing a consent to conduct research that determines the bioavailability of a substance, each volunteer must obtain the following set of information:
After a volunteer signs the contract and the confidentiality agreement, the researchers performed a full medical examination. It includes:
Each house is equipped with everything necessary for comfortable learning. In addition, any insurance company is an agreement about getting insurance in case of a failed experiment. Additional conditions are discussed and the amount of remuneration.
Work with volunteers carries out the researcher. It needs to meet the following conditions:
In addition to researcher in the group should include nurses. Their responsibilities include:
More to the group include:
At the conclusion of all the research actions of the chief doctor issued a paper that should reflect the following items:
A Study on the bioavailability of medicines is carried out in the same dosage on two drugs: the derived and the original. In the case of requests to study multiple drugs the study is carried out separately for each.
The time Interval between taking the generic and the original is determined by the duration of the movement of drugs in the body, the period of partial removal. It needs to be equal to an average of 6 periods of partial removal. The material used for the study, may be plasma, serum or blood. It is taken from a vein in the crook of the elbow through the catheter. The selection must be made three times:
The study can be considered acceptable if the value of the area under the curve "concentration - time” at a distance from zero to the last sample is about 80 %.
Article in other languages:
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Alin Trodden - author of the article, editor
"Hi, I'm Alin Trodden. I write texts, read books, and look for impressions. And I'm not bad at telling you about it. I am always happy to participate in interesting projects."
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