[ bī′ō-fär′mə-sōō′tĭks ] n. The study of the physical and chemical properties of drugs and their proper dosage as related to the onset, duration, and intensity of drug action.
What is meant by the term bioavailability?
(BY-oh-uh-VAY-luh-bul) The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance that is taken by mouth can be absorbed and used by the body.
What do you mean by biopharmaceutics & pharmacokinetics?
Biopharmaceutics is a major branch in pharmaceutical sciences which relates between the physicochemical properties of a drug in dosage form and the pharmacology, toxicology, or clinical response observed after its administration [7].The plasma concentration of the drug is the basic concept of pharmacokinetics.
What is an example of biopharmaceutical?
Currently, biopharmaceuticals have been extensively used as therapeutic agents such as vaccines, whole blood (or blood components), immunosera, antigens, hormones, cytokines, enzymes, allergenics, cell therapies, gene therapies, tissues, monoclonal antibodies, and products derived from recombinant DNA, etc.
What is bioavailability in Biopharmaceutics?
Bioavailability is defined as relative amount of drug from an administered dosage which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
What are the 2 types of bioavailability?
One way to resolve this problem is to define “reliable bioavailability” as positive bioavailability results (an absorption meeting a predefined criterion) that include 84% of the trial subjects and “universal bioavailability” as those that include 98% of the trial subjects.
What is the aim of biopharmaceutics?
The aim of biopharmaceutics is to adjust the delivery of drug from the drug product in such a manner, as to provide optimal therapeutic activity and safety for the patient.
What is the importance of biopharmaceutics?
Biopharmaceutics provides the scientific basis for drug product design and drug product development. Each step in the manufacturing process of a finished dosage form may potentially affect the release of the drug from the drug product and the availability of the drug at the site of action.
What kind of diseases are biopharmaceuticals used for?
Biopharmaceuticals are blockbusters in the treatment of inflammatory diseases, such as psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases, and the introduction of these drugs has revolutionized treatment.
How are biopharmaceuticals developed?
The biopharmaceutical manufacturing process harnesses biosynthesis, which tends to yield far larger, more complex molecules — proteins and nucleic acids — than are typically produced through traditional chemical synthesis. The first such molecule was recombinant human insulin, pioneered by Genentech in 1982.
What is a good bioavailability score?
The majority of compounds have bioavailability score of 0.55 or 0.56, which means good pharmacokinetic properties.
What does therapeutically equivalent mean?
FDA classifies as therapeutically equivalent those drug products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a)contain identical amounts of the identical active drug ingredient in the identical dosage form and route of
How is bioavailability calculated?
Bioavailability is calculated by comparing plasma levels of a drug given via a particular route of administration (for example, orally) with plasma drug levels achieved by IV injection. This is where the AUC comes into play (the area under the curve calculated by plotting plasma concentrations of the drug versus time).
Which is an example of bioavailability?
For example, orally administered morphine has a bioavailability of about 25 percent due to significant first-pass metabolism in the liver. Therefore, the dose of morphine given orally is usually 3–5 times larger than an i.v. dose of morphine.
What is the importance of bioavailability?
Bioavailability is a key indicator of drug absorption. It represents the administered dose fraction which achieves success in reaching the systemic circulation when administered orally or through any other extravascular dosing route.
What affects drug bioavailability?
Drug bioavailability after oral administration is affected by anumber of different factors, including physicochemical properties of the drug, physiological aspects, the type of dosage form, food intake, biorhythms, and intra- and interindividual variability of the human population.
What are the importance of biopharmaceutics and pharmacokinetics studies?
Despite the paucity of biopharmaceutic and pharmacokinetic data for many old drugs, these areas of scientific research have demonstrated an immense value in clinical medicine, and can be expected to expand man’s knowledge of drug action and the influence of physiological function of drug disposition.
What is the relationship of biopharmaceutics pharmacokinetics to the drugs?
Biopharmaceutics examines the interrelationship of the physical/chemical properties of the drug, the dosage form (drug product) in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption.
How will biopharmaceutics affect drug product performance?
Biopharmaceutics links the physical and chemical properties of the drug and the drug product to their performance, in vivo. A primary concern in biopharmaceutics is the bioavailability of drugs. Bioavailability refers to the measurement of the rate and extent of active drug that becomes available at the site of action.
• biopharmaceutics involves factors that influence: • (1) the design of the drug product, • (2) stability of the drug within the drug product, • (3) the manufacture of the drug product, • (4) the release of the drug from the drug product, • (5) the rate of dissolution/release of the drug at the absorption site, • (6)
What is a pharmacodynamic drug?
Abstract. Pharmacodynamic drug-drug interactions (DDIs) occur when the pharmacological effect of one drug is altered by that of another drug in a combination regimen. DDIs often are classified as synergistic, additive, or antagonistic in nature, albeit these terms are frequently misused.
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