منابع مشابه
Joint statement on the U.S. Food and Drug Administration's decision regarding bioequivalence of levothyroxine sodium.
On June 24, 2004, the U.S. Food and Drug Administration (FDA) rejected a citizen petition filed in August 2003 regarding bioequivalence of levothyroxine sodium products and approved first-time generic levothyroixine sodium for the treatment of hypothyroidism. The American Thyroid Association (ATA), The Endocrine Society (TES), and the American Association of Clinical Endocrinologists (AACE), re...
متن کاملReview on Bioavailability and Bioequivalence Studies
Bioavailability is used to describe the fraction of an administered dose of medication that reaches the systemic circulation, one of the principal properties of the drug. By definition, when the drug is administered intravenously, its bioavailability is 100%. Bioequivalence studies compare both the rate and extent of absorption of various multisource drug formulations with the innovator (refere...
متن کاملBioequivalence studies of drugs prescribed mainly for women.
The basic components of pharmacokinetics are absorption, distribution, metabolism, and excretion. During pregnancy there may be changes in one or many of these components. Early drug studies did not include a representative proportion of women, however, researchers as well as regulators agree that studies on the sex differences in the disposition of drugs are important, but at what stage in the...
متن کاملDetermination of Actarit from Human Plasma for Bioequivalence Studies
An analytical method based on high-performance liquid chromatography with ultraviolet detection (245 nm) was developed for the determination of actarit in human plasma. Coumarin was used as an internal standard. Chromatographic separation was achieved with a C8 column using a mobile phase of methanol: 1% acetic acid (50-50, v/v) with a flow rate of 1.0 ml/min. The calibration curve was linear o...
متن کاملBioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers
The relative bioavailability of the test (generic) product 2 × 25 mg baclofen tablets, with respect to the reference product, Lioresal® 2 × 25 mg tablets (baclofen; Squibb) was determined in a single-blind, single dose, randomised, crossover study. The mean values for the variable Cmax were 737.6 ng/ml for the reference and 739.5 ng/ml for the test product. The mean values for the variable AUC ...
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2005
ISSN: 1550-7416
DOI: 10.1208/aapsj070106