Results 141 to 150 of about 9,364 (186)

On population and individual bioequivalence

Statistics in Medicine, 1993
AbstractIn a traditional assessment of the bioequivalence of two formulations of a drug one compares the average bioavailability from the two formulations. Anderson and Hauck argued that in some situations it is not sufficient to demonstrate average bioequivalence, and they proposed a method for the assessment of what they called individual ...
R, Schall, H G, Luus
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The Bootstrap in Bioequivalence Studies

Journal of Biopharmaceutical Statistics, 2011
In 1997, the U.S. Food and Drug Administration (FDA) suggested in its draft guidance the use of new concepts for assessing the bioequivalence of two drug formulations, namely, the concepts of population and individual bioequivalence. Aggregate moment-based and probability-based measures of bioequivalence were introduced to derive criteria in order to ...
Pigeot, Iris, Hauschke, Dieter, Shao, Jun   +2 more
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BIOEQUIVALENCY OF RANITIDINE TABLETS

Journal of Clinical Pharmacy and Therapeutics, 1989
The bioavailability of two brands of ranitidine tablets was studied in 10 healthy volunteers. Formulation factors were compared by performing disintegration, dissolution and content uniformity tests. Plasma concentrations of ranitidine were measured using a sensitive and precise high pressure liquid chromatographic (HPLC) procedure.
H N, Alkaysi, M A, Salem, A M, Gharaibeh, Y M, el-Sayed, K I, Ali-Gharaibeh, A A, Badwan   +5 more
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Bioequivalence of Genotropin and Somatonorm

Acta Paediatrica, 1987
ABSTRACT.Wilton, P., Widlund, L. and Guilbaud O. (Medical Department, KabiVitrum Peptide Hormones AB, Departments of Pharmacology and of Statistics and Computer Services, Research and Development, KabiVitrum AB, Stockholm, Sweden). Bioequivalence of Genotropin and Somatonorm. Acta Paediatr Scand [Suppl] 337:118, 1987.The bioequivalence parameters, AUC,
P, Wilton, L, Widlund, O, Guilbaud
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The Role of Metabolites in Bioequivalence

Pharmaceutical Research, 2004
The role of metabolites in bioequivalence studies has been a contentious issue for many years. Many papers have published recommendations for the use of metabolite data based on anecdotal evidence from the results of bioequivalence studies. Such anecdotal evidence has validity, but the arguments lack weight because the "correct" answers are always ...
Kamal K, Midha, Maureen J, Rawson, John W, Hubbard   +2 more
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Metabolites and Bioequivalence

Clinical Pharmacokinetics, 2004
Although it is widely recognised that measurement of metabolite concentrations is crucial to understanding the clinical pharmacology characteristics of a new molecular entity, a clear consensus on the role of metabolites in the assessment of bioequivalence has never been achieved within the scientific community.
Andre J, Jackson, Gabriel, Robbie, Patrick, Marroum   +2 more
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Open questions in bioequivalence

Pharmacological Research, 1995
Bioequivalence studies are mainly required to demonstrate the interchangeability of multisource pharmaceutical products, usually called generics. A pivotal investigation projected and conducted in compliance with specific guidelines allows a replicative company to register a generic drug via an ANDA (abbreviated new drug application) procedure. Serious
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Determination of in Vivo Bioequivalence

Pharmaceutical Research, 2002
The May and June 2001 issues of Pharmaceutical Research contained three articles related to the determination of in vivo Bioequivalence. The articles discussed: (a) the bioequivalence of highly variable drugs, (b) novel metrics for direct comparison of bioequivalence study plasma curves, and (c) the role of a microemulsion vehicle on cutaneous ...
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Bioequivalence and the immunogenicity of biopharmaceuticals

Nature Reviews Drug Discovery, 2002
The expiry of the first patents for recombinant-DNA-derived biopharmaceuticals will open the possibility of marketing generics, if they can be shown to be essentially similar to the innovator product. However, as shown by the problem of immunogenicity, the properties of biopharmaceuticals are dependent on many factors, including downstream processing ...
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Bioequivalence and Pharmacogenetics

Current Pharmacogenomics and Personalized Medicine, 2014
DEMİRPOLAT, Eren, AYCAN, Mükerrem Betül   +1 more
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