Results 131 to 140 of about 9,364 (186)
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ON THE DETERMINATION OF BIOEQUIVALENCE
Pharmacological Research, 1999The characteristics and advantages of a new method for the determination of bioequivalence are described. This method does not employ AUC or Cmax, therefore it does not depend on a number of assumptions usually needed for the validity of the traditional method.
Aldo Rescigno
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Bioequivalent or Nonbioequivalent?
Pharmacological Research, 2001The 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
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On Bayesian Methods for Bioequivalence
Biometrics, 1984Bayesian methods are presented for assessing bioequivalence for studies in which a new formulation and a standard are administered simultaneously, and for Latin square designs which compare two or more new formulations to a standard. Two examples illustrate the application of the methods.
Selwyn, Murray R., Hall, Nancy R.
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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.
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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.
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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.
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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.
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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
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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
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Consideration of individual bioequivalence
Journal of Pharmacokinetics and Pharmacodynamics, 1990Current procedures for assessing the bioequivalence of two formulations are based on the concept of average bioequivalence. That is, they assess whether the average responses between individuals on the two formulations are similar. Average bioequivalence, however, is not sufficient to guarantee that an individual patient could be expected to respond ...
Walter W Hauck, Hauck Walter W
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Stereochemistry and Bioequivalence
The Journal of Clinical Pharmacology, 1992Despite 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 ...
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Biosimilars: Are They Bioequivalent?
Digestive Diseases, 2014Biologics have revolutionized several areas of medical therapeutics, and dozens of them are used by millions of patients. Monoclonal antibodies are only one type of biologics, but more than 900 are now in different phases of development. These drugs are complex to make and not cheap.
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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 ...
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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 ...
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