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  • 1
    Electronic Resource
    Electronic Resource
    Prevention of HIV-1 IIIB infection in chimpanzees by CD4 immunoadhesin (1991)
    [s.l.] : Nature Publishing Group
    Nature 352 (1991), S. 434-436 
    Details
    ISSN: 1476-4687
    Source: Nature Archives 1869 - 2009
    Topics: Biology , Chemistry and Pharmacology , Medicine , Natural Sciences in General , Physics
    Notes: [Auszug] Two chimpanzees were pretreated with CD4-IgG (5 mg kg"1 given intravenously (i.v.)) at 8 h and 1 h before challenge, then inoculated with 120 tissue culture infectious doses (TCID50s) of HIV-1 IIIB (30 chimp infectious doses). After challenge, the animals received further CD4-IgG treatment for 9 ...
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1038/352434a0
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  • 2
    Electronic Resource
    Electronic Resource
    Interspecies Scaling of Clearance and Volume of Distribution Data for Five Therapeutic Proteins (1991)
    Springer
    Pharmaceutical research 8 (1991), S. 1351-1359 
    Details
    ISSN: 1573-904X
    Keywords: allometric equation ; interspecies scaling ; therapeutic proteins ; pharmacokinetics ; clearance ; volume of distribution ; soluble rCD4 ; CD4-IgG ; growth hormone ; tissue-plasminogen activator ; relaxin
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The clearance and volume of distribution of five human proteins (recombinant CD4, CD4 immuno-globulin G, growth hormone, tissue-plasminogen activator, and relaxin) in humans and laboratory animals were analyzed as a function of body weight using allometric scaling techniques. These proteins cover a 16-fold range of molecular weight (6 to 98 kD), are produced by recombinant or synthetic methods, and may be cleared by different mechanisms. The analyses revealed that the clearance and volume data for each protein were satisfactorily described by an allometric equation (Y = a Wb). The allometric exponent (b) for clearance (ml/min) ranged from 0.65 to 0.84, the allometric exponent for the initial volume of distribution (ml) ranged from 0.83 to 1.05, and the allometric exponent for the volume of distribution at steady state (ml) ranged from 0.84 to 1.02. Exponent values from 0.6 to 0.8 for clearance and 0.8 to 1.0 for volumes are frequently cited for small molecules and are expected based on empirical interspecies relationships. When the preclinical data were analyzed separately, the pre-clinical allometric relationships were usually predictive of the human results. These findings indicate that the clearance and volume of distribution of select biomacromolecules follow well-defined, size-related physiologic relationships, and preclinical pharmacokinetic studies provide reasonable estimates of human disposition. Employing this methodology during the early phases of drug development may provide a more rational basis for dose selection in the clinical environment.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1015836720294
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Protracted benzene exposure causes a proliferation of myeloblasts and/or promyelocytes in CD-1 mice (1981)
    Springer
    Bulletin of environmental contamination and toxicology 27 (1981), S. 17-22 
    Details
    ISSN: 1432-0800
    Source: Springer Online Journal Archives 1860-2000
    Topics: Energy, Environment Protection, Nuclear Power Engineering , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01610980
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  • 4
    Electronic Resource
    Electronic Resource
    Pharmacokinetics and Tissue Distribution of Recombinant Human Transforming Growth Factor Beta1 After Topical and Intravenous Administration in Male Rats (1994)
    Springer
    Pharmaceutical research 11 (1994), S. 213-220 
    Details
    ISSN: 1573-904X
    Keywords: recombinant human transforming growth factor beta1 ; wound-healing ; pharmacokinetics ; plasma-based enzyme-linked immunosorbent assay (ELISA) ; tissue distribution
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Recombinant human transforming growth factor beta (rhTGF-β1) enhances the healing process after topical application to various animal wound models. A detailed pharmacokinetic and tissue distribution study was performed to support the clinical development of rhTGF-β1 for wound healing indications. Rats received radioiodinated or unlabeled rhTGF-β1 as an intravenous (iv) bolus or as a topical formulation applied to a full thickness wound. Plasma concentrations of TGF-β1 were estimated from TCA-precipitable radioactivity or were measured by ELISA. Following iv administration, the initial half-life was rapid (〈11 min), regardless of whether radi-olabeled or unlabeled rhTGF-β1 was used. The terminal half-life was long (163 min) when the test material was radioiodinated and administered as a trace dose and relatively short (≤61 min) when given at high doses and assayed by ELISA. Analysis of plasma radioactivity by SDS-PAGE revealed a time-dependent clearance of the 25-kDa parent molecule without a significant appearance of lower molecular weight radiolabeled metabolites. The majority of the radioactivity was associated with highly perfused organs, known iodide elimination pathways, and the thyroid at 1 and 8 hr after iv injection. After topical administration of a high dose (0.8 mg/kg), no immunoreactive TGF-β1 was detectable in plasma samples taken over a 48-hr period. However, trace amounts (≤0.05 ng/mL) of acid-precipitable radioactivity were detected in plasma after topical application of [125I]rhTGF-β1 (1 µg/kg, 126 µCi/kg). A significant portion (35%) of the [125I]rhTGF-β1 persisted intact (25 kDa) at the wound site 24 hr after application. In conclusion, rhTGF-β1 was rapidly cleared after iv bolus administration and distributed primarily to the liver, lungs, kidney, and spleen. Little systemic exposure was observed after applying a single topical dose of rhTGF-β1 to a wound, and the intact molecule persisted at the wound site.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018995005775
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  • 5
    Electronic Resource
    Electronic Resource
    Design of Biological Equivalence Programs for Therapeutic Biotechnology Products in Clinical Development: A Perspective (1996)
    Springer
    Pharmaceutical research 13 (1996), S. 1427-1437 
    Details
    ISSN: 1573-904X
    Keywords: bioequivalence ; biotechnology products ; recombinant proteins ; pharmacokinetics ; pharmacodynamics ; efficacy ; immunogenicity ; safety
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The determination of biological equivalence requires that studies are conducted to establish that two molecules, two formulations, or two dosing regimens, for example, are indistinguishable with respect to safety and efficacy profiles that have been previously established. The criteria that are used to establish biological equivalence will depend on the nature of the change (e.g., molecular, process, formulation), the stage of the development program, the duration of treatment, and the intended clinical indications. Key components of an equivalence program include chemical characterization, in vitro and in vivo bioactivity against reference material, pharmacokinetics, and safety. Special considerations for patient populations, endogenous concentrations, environmental factors, immunogenicity, assay methodology, biochemical identity, pharmacodynamic equivalence, and statistical methodology are discussed. In addition, the role of preclinical in vivo assessments is addressed. Specific case studies provide insight into the varied nature of approaches that are currently employed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1016002823485
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