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  • 1
    Electronic Resource
    Electronic Resource
    Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry (1997)
    Springer
    Accreditation and quality assurance 2 (1997), S. 140-145 
    Details
    ISSN: 1432-0517
    Keywords: Key words Analytical method and procedure ; Validation ; Quality control laboratory ; Documentation ; Robotic analysis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  Analytical validation is required as the basis for any evaluation activities during manufacturing process validation, cleaning validation and validation of the testing method itself in the pharmaceutical industry according to good manufacturing practice (GMP) rules and guidelines. Validation of analytical methods and procedures in a quality control (QC) laboratory is implemented mainly at the time of transfer or introduction of the methods developed by the analytical development laboratory within group companies or elsewhere. However, it is sometimes necessary to develop a new or improved method of analysis for the QC laboratory's own use. In the first part of this report, a general description of analytical validation of the high performance liquid chromatography (HPLC) method including preparation of documents is presented based on the experience in our QC laboratory. A typical example of method validation of robotic analysis system is then cited. Finally the merits and demerits of these analytical validations for QC laboratories are summarized. The authors emphasize the importance of analytical validation and the responsibility of QC laboratory management for the effective design and implementation of validation activities.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050119
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  • 2
    Electronic Resource
    Electronic Resource
    Absorption of elastase through the jejunal mucosa of the rat (1984)
    Springer
    Histochemistry and cell biology 81 (1984), S. 427-433 
    Details
    ISSN: 1432-119X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary In order to reveal the absorption process of elastase from the intestine, hog pancreatic elastase was injected into the ligated jejunum lumen of the rat, and the tissues were cytochemically observed at various times after injection. The peroxidase anti-peroxidase (PAP) method using anti-hog-elastase rabbit antibody was used for light microscopy, and the anti-elastase Fab′-peroxidase conjugate was used for electron microscopy. The tissues stained by the PAP method exhibited a dense deposition of reaction products on the luminal surface of epithelial cells and a moderate deposition in the blood and lymph capillaries of the intestinal villi. Immunoelectron microscopy revealed that the reaction product was deposited on the surface of the microvilli and in their pocketing; some was found in the pinocytotic vesicles in the terminal-web area and on the inner surface of the enlarged smooth endoplasmic reticulum. Round droplets which gave a positive reaction were found in the widened intercellular cleft and the thick basement membrane lining the blood capillaries and lymphatics. The jejunum retained its normal ultrastructure. The results indicate that the elastase molecules, which were introduced into the rat jejunum lumen, were absorbed without being decomposed through healthy intestinal epithelial cells by pinocytosis and translocated into blood and lymph capillaries.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00489745
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  • 3
    Electronic Resource
    Electronic Resource
    Histochemical studies on the mechanism of macromolecule leakage across the glomerular capillary wall (1991)
    Springer
    Histochemistry and cell biology 96 (1991), S. 115-121 
    Details
    ISSN: 1432-119X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary For the purpose of revealing the barrier effect of the anionic groups of glomerular capillary wall against the serum protein leakage, morphologic and histochemical observations were made on the rat kidney perfused in situ with three kinds of cationic macromolecules different in chemical characteristics followed by blood flow restoration. The polyethyleneimine perfusion resulted in the complete disappearance of ionized anionic groups of glomerular capillary and the massive protein leakage through glomeruli by blood flow restoration. Cationic ferric colloid perfusion induced moderate protein leakage, and avidin perfusion was less in neutralization effect of anionic groups and the protein leakage was of least. The protein leakage from glomeruli, however, was stopped or markedly suppressed soon after the blood flow restoration by the newly formed functioning anionc barrier probably by some particular serum protein deposition. The findings indicate that the deionization of the glomerular capillary wall will not be responsible for the persistent albuminuria.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00315981
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  • 4
    Electronic Resource
    Electronic Resource
    Cationic cacodylate iron colloid for the detection of anionic sites on cell surface and the histochemical stain of acid mucopolysaccharides (1983)
    Springer
    Histochemistry and cell biology 78 (1983), S. 27-31 
    Details
    ISSN: 1432-119X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary Stable cationic iron colloid solution was prepared by mixing the Hale's iron colloid (Hale 1946; Mowry 1963) with sodium cacodylate buffer solution. The colloid particles obtained were 30–50 Å in size and kept their positive charges in a wide range of pH 1.8–7.6. Observations made on rat kidney tissues proved that this iron colloid solution is promising for the detection of anionic sites of cell surface in fixed tissues as well as in living cells in place of cationic ferritin.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00491108
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  • 5
    Electronic Resource
    Electronic Resource
    Fine-granular cationic iron colloid (1985)
    Springer
    Histochemistry and cell biology 82 (1985), S. 307-312 
    Details
    ISSN: 1432-119X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary In order to obtain distinct and reliable information concerning the localization of ionized anionic groups in tissues, fine-granular cationic ferric hydroxide colloid solution (Fe-Cac-f) was newly devised. This can be obtained by boiling a mixture of ferric chloride and ammonium cacodylate solutions. the colloid particles of Fe-Cac-f are about 1.0 nm in size, i.e., one-fifth of the size of ferric cacodylate colloid (Fe-Cac; Seno et al. 1983a). As with Fe-Cac, Fe-Cac-f particles in the pH range of 1.6–7.6 carry a positive electric charge, but the latter show a better permeation of tissues. Using the Prussian blue reaction, Fe-Cac-f gives a distinct deep-blue color and can be used for the detection of anionic groups of acid mucopolysaccharides and proteins by light microscopy. It is also useful for detecting the exact sites of ionized anionic groups in deep tissue areas using electron microscopy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00494058
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  • 6
    Electronic Resource
    Electronic Resource
    The circulating α1-antitrypsin-elastase complex attacks the elastic lamina of blood vessels (1988)
    Springer
    Histochemistry and cell biology 88 (1988), S. 443-451 
    Details
    ISSN: 1432-119X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary The aim of the study was to determine the destination of the α1-antitrypsin-elastase complex, which is found in circulating blood after the peroral administration of elastase. The complex was made in vitro by mixing hog pancreatic elastase with human α1-antitrypsin and then injected intravenously into rats and mice. Tissues taken at various times after injection were subjected to histochemical staining using an antibody against elastase. Light micro-scope observations revealed dense deposition of reaction products in the elastic lamina of the arterioles; moderate or slight deposits were seen in the tissues surrounding arteries, in the tubular epithelial cells of the proximal convoluted tubules in the kidney, and in the pancreatic ducts.Immuno-electron microscopy revealed heavy deposition of the reaction product in the elastic lamina of the small arteries and arterioles; some dissolution of the elastic fibers was also evident. Pinocytic uptake of the α1-antitrypsin-elastase complex was observed on the abluminal surface of endothelial cells and in smooth-muscle cells bordering the elastic lamina of arterioles. The endothelial cells of the arteries and arterioles retained their normal morphological appearance, although local desquamation was observed in some animals. The results indicate that, when the α1-antitrypsin-elastase complex is present in the circulating blood, it is incorporated into the elastic lamina through the endothelial layer. This results in liquefaction of the lamina, desquamation of endothelial cells and leakage of the complex into the perivascular tissues via the vascular walls. However, some of the complex seems to be excreted very quickly from the kidneys.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00570307
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  • 7
    Electronic Resource
    Electronic Resource
    A new method of the immunohistochemical detection of cellular antigens for light and electron microscopy (1989)
    Springer
    Histochemistry and cell biology 91 (1989), S. 449-454 
    Details
    ISSN: 1432-119X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary A new immunohistochemical method for light and electron microscopy of tissue- and cell-specific antigens by using ferric colloid-labeled antibody is presented. The antibodies labeled with the cationic cacodylate ferric colloid are stable and bind specifically to the target antigens to show clearly the site of antigens in tissue sections and on free cells by Prussian blue reaction for light microscopy and by the specific figure of electron opaque ferric colloid particles for electron microscopy. The staining procedure is very simple and it gives clear picture. So the method will be of beneficial for general laboratory use in immuno-histochemical researches.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00492514
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  • 8
    Electronic Resource
    Electronic Resource
    The anionic barrier system in the mesonephric renal glomerulus of the arctic lamprey, Entosphenus japonicus (Martens) (Cyclostomata) (1984)
    Springer
    Cell & tissue research 235 (1984), S. 491-496 
    Details
    ISSN: 1432-0878
    Keywords: Mesonephric glomerulus (lamprey) ; Anionic barrier ; Cationic cacodylate-iron colloid ; Native anionic and cationized ferritins
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine
    Notes: Summary To examine the selective permeability of the nephrons of lower vertebrates, the permeability of the glomerulus in the kidney of an arctic lamprey, Entosphenus japonicus (Martens), to native anionic ferritin or cationized ferritin was studied by observing the distribution of ionized anionic groups in renal tissues. The cationized ferritin molecules injected into the dorsal aorta penetrated rapidly into the glomerular basement membrane layer through fenestrae present in the capillary endothelium and were subsequently excreted into the urinary spaces via the interstices between foot processes of the visceral epithelial cells. Native anionic ferritin, on the other hand, passed only minimally through the capillary wall. Cytochemical staining of fixed tissue or perfusion of the kidney in situ with cationic cacodylate-iron colloid revealed that the ionized anionic groups of acid mucopolysaccharides were distributed on both the luminal and abluminal surfaces of endothelial cells, and in the thick fibrous lamina rara interna of the glomerular basement membrane; they were especially dense on the surfaces of visceral epithelial cells and their foot processes. These results suggest that the mesonephric glomerulus of the arctic lamprey possesses a functionally well developed anionic barrier system comparable to that of the mammalian metanephric glomerulus.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00226944
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  • 9
    Electronic Resource
    Electronic Resource
    Gene ecology: Acis-acting gene-to-gene interaction due to the spatial arrangement of genes in chromosomes affects neighbouring transfected c-H-ras expression (1994)
    Springer
    Chromosome research 2 (1994), S. 171-183 
    Details
    ISSN: 1573-6849
    Keywords: gene-to-gene interaction ; reversible cancer cell conversion ; spatial arrangement of genes ; trans-criptional regulation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology
    Notes: Abstract Acis-acting interference between gene activities, which occurs when two genes lie on the same DNA strand and have an Intergenic distance less than a defined length, was previously deduced when chromo-somal organizations of various higher eukaryote nuclear genes in clusters were compared. In order to investigate such an interference due to arrangement of genes along chromosomes, we have isolated a few cell lines which possessed (i) human mutated c-H-ras fused with the mouse mammary tumour virus long terminal repeat and (ii) theE. coli xanthine-guanine phosphoribosyltransferase (gpt) gene with the SV40 promoter, on the same or on different DNA strands, separated by a short intergenic distance or unlinked. Since the cancerous phenotype of a cell can be readily identified due to c-H-ras expression, we examined in these cell lines whether continuous c-H-ras expression, induced by dexamethasone, is disturbed through acis-acting gene-to-gene interaction when the expression of the neighbouringgpt gene is enforced and as a result, the cancerous state of a cell is converted to the ‘normal’ state. The enforced expression of the neighbouringgpt gene was shown to alter c-H-ras expression, and thus reversible conversion of a cell between cancerous and normal states occurred only when the cell possessed an optimum number of the gene pair, in which both c-H-ras and thegpt gene were on the same DNA strand. This implies that the spatial arrangement of genes in chromosomes plays an important role in the regulation of gene expression in a cluster.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01553317
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  • 10
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    The anionic barrier system in the mesonephric renal glomerulus of the arctic lamprey, Entosphenus japonicus (Martens) (Cyclostomata) (1984)
    Springer
    Details
    Publication Date: 1984-03-01
    Print ISSN: 0302-766X
    Electronic ISSN: 1432-0878
    Topics: Biology , Medicine
    Published by Springer
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