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Challenges in the Investigation of Therapeutic Equivalence of Locally Applied/Locally Acting Drugs in the Gastrointestinal Tract: The Rifaximin Case. [PDF]
PharmaceuticsTsakiridou G +4 more
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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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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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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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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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