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Monday, 30 June 2008

Bioequivalency and Bioavailability

The main characteristic of a non-intravenous dosage form, intended for the treatment of a systemic condition, is the possibility of the active substance in the bloodstream in an amount sufficient to cause the desired response. This attribute of a dosage form of traditionally identified as physiological availability, bioavailability or bioavailability. The bioavailability saves two essential characteristics, namely how fast the drug into the systemic circulation (absorption) and how much of the nominal strength shall enter the body (degree of absorption). Given the fact that the therapeutic effect is a function of the concentration of the drug in the blood of a patient, these two characteristics of non-intravenous administration are basically important in identification of the reaction to a drug dose. The beginning of the response is linked to the speed of absorption of drugs that the time-dependent degree of response is linked to the degree of absorption of drugs. Although the bioavailability of each type of non-intravenous product (eg oral, inhalation, topical (eg patch), rectal, etc.) can be discussed, this chapter will have to focus exclusively on orally administered products. They certainly represent the largest class in pharmaceutical drug development and treatment of patients.

The bioavailability after oral doses may vary due either to the patient associated with the dosage or form -related factors. Patient factors may include the nature and timing of the meals, age, illness, genetic characteristics and gastro-intestinal physiology. The dosage form factors include 1) the chemical form of the drug (such as salt
vs acid), 2) the physical properties (eg crystalline structure, particle size), and 3) an array of the wording (eg non-active ingredients) and industry (eg tablet hardness) variables.

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