Ad
related to: bioequivalence drug example
Search results
Results From The WOW.Com Content Network
Bioequivalence. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. One article defined bioequivalence by stating that ...
The model outputs for a drug can be used in industry (for example, in calculating bioequivalence when designing generic drugs) or in the clinical application of pharmacokinetic concepts. Clinical pharmacokinetics provides many performance guidelines for effective and efficient use of drugs for human-health professionals and in veterinary medicine .
Bioequivalence Studies in Drug Development: Methods and Applications. Statistics in Practice. Chichester, UK: John Wiley and Sons. pp. 17–36. ISBN 978-0-470-09475-4; Chow, Shein-Chung; Liu, Jen-pei (15 October 2008). Design and Analysis of Bioavailability and Bioequivalence Studies. Biostatistics Series. Vol. 27 (3rd ed.).
A drug is considered highly soluble when the highest dose strength is soluble in 250 ml or less of aqueous media over the pH range of 1 to 7.5. The volume estimate of 250 ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water.
A generic drug, or simply generic, is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in ...
Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure ...
Short term drug side effects are most likely to occur at or near the C max, whereas the therapeutic effect of drug with sustained duration of action usually occurs at concentrations slightly above the C min. [citation needed] The C max is often measured in an effort to show bioequivalence (BE) between a generic and innovator drug product. [4]
An example for a simple case (mono-compartmental) would be to administer D=8 mg/kg to a human. A human has a blood volume of around V b l o o d = {\displaystyle V_{blood}=} 0.08 L/kg . [ 7 ] This gives a C 0 = {\displaystyle C_{0}=} 100 μg/mL if the drug stays in the blood stream only, and thus its volume of distribution is the same as V b l o ...