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Bioequivalency characterization

For the dissolution test to be used as an effective drug product characterization and quality control tool, the method must be developed with the various end uses in mind. In some cases, the method used in the early phase of product and formulation development could be different from the final test procedure utilized for control of the product quality. Methods used for formulation screening or BA and/or bioequivalency evaluations may simply be impractical for a quality control environment. It is essential that with the accumulation of experience, the early method be critically re-evaluated and potentially simplified, giving preference to compendial apparatus and media. Hence, the final dissolution method submitted for product registration may not necessarily closely imitate the in vivo environment but should still test the key performance indicators of the formulation. [Pg.353]

Kalantzi, L. et al., Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studiiSiarm. Res., 23, 165, 2006. [Pg.112]

There are instances of older designs of needle-free injectors that, even with a well-characterized molecule such as insulin, show substantial differences between needle-free and needle delivery. However, improvements in the understanding of the aforementioned principles as well as advancements in the design of needle-free injectors have led to the recent reporting of improved clinical data. Table 1 summarizes an incomplete list of drugs for which there exist clinical data from needle-free administration, all of which demonstrated broadly similar performance between the needle-free system and the needle system (not every report provides sufficient data to determine if bioequivalence was demonstrated). [Pg.1214]

When assessing bioequivalence, the following three parameters that characterize the plasma or blood concentration-time profile of the administered drug are usually measured ... [Pg.1893]

Kalantzi L, Goumas K, Kalioras V, Abrahamsson B, Dressman JB, and Reppas C. Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies. PharmRes 2006 23 165-176. [Pg.173]

Phase I should estimate a range of safe dose levels up to a maximum tolerated dose, and characterize the pharmacokinetic profile of the study drug in humans. Generally a single dose study and a 1 week repeated-dose study are conducted in a small number (6 8) of healthy male volunteers. Food effects, drug interactions, and bioequivalence studies nowadays belong to this clinical pharmacology phase, as well as pharmacokinetics in the elderly and studies in subjects with poor kidney or hepatic function. [Pg.317]


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See also in sourсe #XX -- [ Pg.1893 ]




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Bioequivalency

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