Results 121 to 130 of about 9,371 (163)

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 Pharmacogenetics

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

Journal of Pharmaceutical Sciences, 1978
S, Hwang, P B, Huber, M, Hesney, K C, Kwan   +3 more
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Bioequivalence and intrasubject variability

Journal of Biopharmaceutical Statistics, 1991
Bioequivalence of the two formulations refers to the equivalence of the marginal distributions of the two formulations. Under normal assumptions, this would require the equivalence of both average and intrasubject variability of bioavailability. A procedure is introduced for the equivalence in intrasubject variability for bioavailability/bioequivalence
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Thyroxine Bioequivalency

Annals of Internal Medicine, 1985
BARRY A. WARNER, RICARDO DEGUZMAN
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