Results 131 to 140 of about 9,047 (170)

Bioequivalence

International Journal of Pharmaceutical Medicine, 2006
Bioequivalence has been the topic of many publications since its development in the late twentieth century for the protection of public health when changing formulations of orally administered products. This review paper describes the international regulations for this purpose and provides an outline of major steps in the development of the ...
Scott D. Patterson, Byron Jones
openaire   +1 more source

Bioequivalence

Pharmaceutical Research, 1992
The bioequivalence of two formulations of the same drug may be determined by evaluating the similarity of their respective plasma concentration curves. The similarity of two plasma concentration functions can be measured by an index called the bioequivalence index. This paper shows how such an index may be defined and calculated.
openaire   +2 more sources

Bioequivalence revisited

Statistics in Medicine, 1992
AbstractThe FDA permits marketing of a generic formulation of a drug G for the same indications as a standard preparation S if one can show that G is bioequivalent to S. Present implementation requires convincing evidence that the population mean difference in bioavailability (drug exposure) between the two preparations lies within specified bounds ...
openaire   +2 more sources

Bioequivalent or Nonbioequivalent?

Pharmacological Research, 2001
The current tests for bioequivalence are based on assumptions that are not valid in general; this paper shows why it is necessary to use a method that does not depend upon assumptions that cannot, and need not, be proved in general.
A, Rescigno, J, Powers, E E, Herderick
openaire   +2 more sources

Individual Bioequivalence Revisited

Clinical Pharmacokinetics, 2001
For decades, the establishment of bioequivalence has generally relied on the comparison of population averages between the test and reference formulations. In the early 1990s, individual bioequivalence was proposed to ensure that an individual could be switched from the reference product to the test product with unchanged efficacy and safety.
M L, Chen, L J, Lesko
openaire   +2 more sources

Stereochemistry and Bioequivalence

The Journal of Clinical Pharmacology, 1992
Despite the fact that many important drugs are chiral, for a variety of reasons they are marketed as racemates (i.e., an equal proportion of two enantiomers). Although enantiomers of racemic drugs often differ from one another in their pharmacodynamic and pharmacokinetic properties, bioequivalence assessments are made using nonstereospecific assays ...
openaire   +2 more sources

Bridging Bioequivalence Studies

Journal of Biopharmaceutical Statistics, 2004
In some new regions, an innovative drug of the original region was not marketed. However, after the patent of the innovative drug is expired, a generic copy of the innovative drug from the original region was introduced and approved for marketing in the new region.
openaire   +2 more sources

On Testing for Bioequivalence

Biometrics, 1984
A number of methods have been proposed for statistical analysis of bioequivalence trials. A new method is proposed and compared to three previously suggested techniques. This comparison clarifies the relationship among the four methods and yields practical suggestions regarding statistical tests.
openaire   +3 more sources