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Article ; Online: Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland

Rachael Wood / Marion Bennie / John Paul Leach / Gavin MacColl / Stuart McTaggart / Karen Gronkowski

BMJ Open, Vol 12, Iss

a population-based cohort study

2022 Volume 4

Keywords	Medicine ; R
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland: a population-based cohort study.

McTaggart, Stuart / MacColl, Gavin / Gronkowski, Karen / Wood, Rachael / Leach, John Paul / Bennie, Marion

BMJ open

2022 Volume 12, Issue 4, Page(s) e058312

Abstract: Objective: To examine the impact of Medicines and Healthcare products Regulatory Agency (MHRA) safety alerts on valproate prescribing among women aged 14-45 years in Scotland and examine trends in pregnancies exposed to valproate.: Design: Population- ...

Abstract	Objective: To examine the impact of Medicines and Healthcare products Regulatory Agency (MHRA) safety alerts on valproate prescribing among women aged 14-45 years in Scotland and examine trends in pregnancies exposed to valproate. Design: Population-based cohort study. Participants: 21 983 women of all ages who received valproate between January 2011 and December 2019. Methods: All valproate prescriptions issued to women in Scotland between January 2011 and December 2019 were identified and prevalence/incidence rates per 10 000 population derived. The impact of regulatory safety alerts on prescribing was analysed using Joinpoint models. Linked pregnancy records for January 2011 to September 2019 were identified and annual rates of pregnancy per 1000 valproate-treated women aged 14-45 years were calculated for each pregnancy outcome: live birth, stillbirth, miscarriage and termination. Results: Annual prevalent and incident rates of valproate prescribing declined in women aged 14-45 years between 2011 and 2019 from 40.5 to 18.3 per 10 000 population (54.8% reduction) and 7.9 to 1.3 per 10 000 population (83.5% reduction), respectively. Statistically significant changes occurred around the times of the MHRA safety alerts. The number of valproate-exposed pregnancies conceived each year fell from 70 in 2011 to 20 in 2018, a 71.4% reduction, and the number of live births fell from 52 to 14, a 73.0% reduction. Expressed as a rate this was a 46.4% decrease from 15.3 to 8.2 per 1000 valproate-treated women aged 14-45 years in 2011 and 2018, respectively. Live birth was the most common pregnancy outcome. Conclusion: This study demonstrates, for the first time, the capabilities of national data sets to identify drug exposure and derive pregnancy outcome at scale across Scotland. Building on this as part of an evolving national/UK surveillance capability will continue efforts to minimise in-utero exposure to valproate; enabling ongoing surveillance to understand better long-term outcomes, and to inform better provision of health and wider support services.
MeSH term(s)	Abortion, Spontaneous ; Cohort Studies ; Female ; Humans ; Male ; Pregnancy ; Pregnancy Outcome/epidemiology ; Scotland/epidemiology ; Valproic Acid/adverse effects
Chemical Substances	Valproic Acid (614OI1Z5WI)
Language	English
Publishing date	2022-04-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-058312
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Article ; Online: Fall in peptic ulcer mortality associated with increased consultant input, prompt surgery and use of high dependency care identified through peer-review audit.

Aga, Hiba / Readhead, David / Maccoll, Gavin / Thompson, Alastair

BMJ open

2012 Volume 2, Issue 1, Page(s) e000271

Abstract: Objectives: Patients with peptic ulceration continue to present to surgeons with complications of bleeding or perforation and to die under surgical care. This study sought to examine whether improved consultant input, timely interventions and ... ...

Abstract	Objectives: Patients with peptic ulceration continue to present to surgeons with complications of bleeding or perforation and to die under surgical care. This study sought to examine whether improved consultant input, timely interventions and perioperative care could reduce mortality from peptic ulcer. Design: Prospective collection of peer-review mortality data using Scottish Audit of Surgical Mortality methodologies (http://www.SASM.org) and analysed using SPSS. Setting: Secondary care; all hospitals in Scotland, UK, admitting surgical patients over 13 years (1994-2006). Participants: 42 736 patients admitted (38 782 operative and 3954 non-operative) with peptic ulcer disease; 1952 patients died (1338 operative and 614 non-operative deaths) with a diagnosis of peptic ulcer. Primary and secondary outcome measures: Adverse events; consultant presence at operation, operations performed within 2 h and high dependency/intensive therapy unit (HDU/ITU) use. Results: Annual mortality fell from 251 in 1994 to 83 in 2006, proportionately greater than the reduction in hospital admissions with peptic ulcer. Adverse events declined over time and were rare for non-operative patients. Consultant surgeon presence at operation rose from 40.0% in 1994 to 73.4% in 2006, operations performed within 2 h of admission from 10.3% in 1994 to 28.1% in 2006 and HDU/ITU use from 52.7% in 1994 to 84.4% in 2006. Consultant involvement (p=0.005) and HDU/ITU care (p=0.026) were significantly associated with a reduction in operative deaths. Conclusion: Patients with complications of peptic ulceration admitted under surgical care should be offered consultant surgeon input, timely surgery and HDU/ITU care.
Language	English
Publishing date	2012-02-22
Publishing country	England
Document type	Journal Article
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2011-000271
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Article ; Online: Biology of KAL1 and its orthologs: implications for X-linked Kallmann syndrome and the search for novel candidate genes.

MacColl, Gavin S / Quinton, Richard / Bülow, Hannes E

Frontiers of hormone research

2010 Volume 39, Page(s) 62–77

Abstract: Kallmann syndrome is characterised by congenital hypogonadotropic hypogonadism and anosmia, sometimes with other non-reproductive defects. Although multiple genetic pathways are now known to be involved in the development of this disorder, KAL1, the gene ...

Abstract	Kallmann syndrome is characterised by congenital hypogonadotropic hypogonadism and anosmia, sometimes with other non-reproductive defects. Although multiple genetic pathways are now known to be involved in the development of this disorder, KAL1, the gene causing the X-linked form of Kallmann syndrome was the first to be identified. It has thus been extensively studied both in vitro and in vivo, though the absence of an identifiable murine ortholog has denied researchers the opportunity to create and study Kal-1 knock-out mice. This review looks at several studies in species with a kal-1 ortholog, revealing functional similarities with the human disorder. Further work has shown that the kal-1 domain structure is maintained across genera, that it controls similar morphological and cellular processes during development, and that data from the nematode Caenorhabditis elegans, in particular, may point to novel human candidate genes.
MeSH term(s)	Animals ; Caenorhabditis elegans ; Cell Movement/genetics ; Extracellular Matrix Proteins/genetics ; Extracellular Matrix Proteins/physiology ; Genes, X-Linked ; Gonadotropin-Releasing Hormone/physiology ; Heparitin Sulfate/metabolism ; Humans ; Kallmann Syndrome/genetics ; Mice ; Nerve Tissue Proteins/genetics ; Nerve Tissue Proteins/physiology ; Neurons/physiology ; Phylogeny ; Sequence Homology
Chemical Substances	ANOS1 protein, human ; Extracellular Matrix Proteins ; Nerve Tissue Proteins ; Gonadotropin-Releasing Hormone (33515-09-2) ; Heparitin Sulfate (9050-30-0)
Language	English
Publishing date	2010-04-08
Publishing country	Switzerland
Document type	Journal Article ; Review
ISSN	1662-3762 ; 0301-3073
ISSN (online)	1662-3762
ISSN	0301-3073
DOI	10.1159/000312694
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Article: Recent advances in the pathogenesis of Kallmann's syndrome.

Bouloux, Pierre-Marc / Hu, Youli / MacColl, Gavin

Progress in brain research

2002 Volume 141, Page(s) 79–83

MeSH term(s)	Extracellular Matrix Proteins ; Female ; Gonadotropin-Releasing Hormone/deficiency ; Humans ; Incidence ; Kallmann Syndrome/epidemiology ; Kallmann Syndrome/genetics ; Kallmann Syndrome/physiopathology ; Male ; Nerve Tissue Proteins/genetics ; Neurons/physiology ; Sex Characteristics
Chemical Substances	Extracellular Matrix Proteins ; KAL1 protein, human ; Nerve Tissue Proteins ; Gonadotropin-Releasing Hormone (33515-09-2)
Language	English
Publishing date	2002
Publishing country	Netherlands
Document type	Journal Article ; Review
ISSN	0079-6123
ISSN	0079-6123
DOI	10.1016/S0079-6123(02)41085-0
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Article: GnRH neuronal development: insights into hypogonadotrophic hypogonadism.

MacColl, Gavin / Quinton, Richard / Bouloux, Pierre M G

Trends in endocrinology and metabolism: TEM

2003 Volume 13, Issue 3, Page(s) 112–118

Abstract: Pulsatile secretion of the hypothalamic decapeptide gonadotrophin-releasing hormone (GnRH) regulates activity of the pituitary-gonadal reproductive axis. Defects of this neuroendocrine axis necessarily result in hypogonadotrophic hypogonadism. In many ... ...

Abstract	Pulsatile secretion of the hypothalamic decapeptide gonadotrophin-releasing hormone (GnRH) regulates activity of the pituitary-gonadal reproductive axis. Defects of this neuroendocrine axis necessarily result in hypogonadotrophic hypogonadism. In many vertebrate species studied, the main population of GnRH neurones originates extracranially within the olfactory system. In humans, both olfactory and GnRH systems are affected in Kallmann's syndrome--resulting in isolated hypogonadotrophic hypogonadism (IHH) combined with anosmia (loss of sense of smell). Familial IHH is also caused by other genetic conditions, which prevent GnRH from activating luteinizing hormone/follicle-stimulating hormone release from pituitary gonadotrophs. However, many cases of IHH have no defined chromosomal abnormality and, in the absence of pedigree analysis, studying the biological mechanisms controlling migration of GnRH neurones through the olfactory system into the developing central nervous system might reveal additional genetic pathways that play a role in the pathogenesis of IHH.
MeSH term(s)	Animals ; Cell Movement/physiology ; Central Nervous System/physiology ; Gonadotropin-Releasing Hormone/analogs & derivatives ; Gonadotropin-Releasing Hormone/physiology ; Humans ; Hypogonadism/etiology ; Hypogonadism/genetics ; Hypogonadism/physiopathology ; Kallmann Syndrome/complications ; Kallmann Syndrome/genetics ; Kallmann Syndrome/physiopathology ; Neurons/physiology ; Olfaction Disorders/genetics ; Olfaction Disorders/physiopathology
Chemical Substances	Gonadotropin-Releasing Hormone (33515-09-2)
Language	English
Publishing date	2003-02-21
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1042384-9
ISSN	1879-3061 ; 1043-2760
ISSN (online)	1879-3061
ISSN	1043-2760
DOI	10.1016/s1043-2760(01)00545-8
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Article: Kallmann syndrome: adhesion, afferents, and anosmia.

MacColl, Gavin / Bouloux, Pierre / Quinton, Richard

Neuron

2002 Volume 34, Issue 5, Page(s) 675–678

Abstract: Three new studies into the function of human anosmin-1 and related proteins in C. elegans and rodents show that these influence axon branching and axon targeting. The rodent anosmin appears to work at two stages of development, initially promoting axon ... ...

Abstract	Three new studies into the function of human anosmin-1 and related proteins in C. elegans and rodents show that these influence axon branching and axon targeting. The rodent anosmin appears to work at two stages of development, initially promoting axon outgrowth from the olfactory bulb and then stimulating branching from axons into the olfactory cortex. CeKal-1 further influences morphogenesis, and, as the human and nematode anosmins are functionally conserved, these studies provide insights into the pathogenesis of Kallmann syndrome (KS).
MeSH term(s)	Animals ; Cell Adhesion/genetics ; Cell Adhesion Molecules/deficiency ; Cell Adhesion Molecules/genetics ; Cell Differentiation/genetics ; Cell Movement/genetics ; Extracellular Matrix Proteins ; Humans ; Kallmann Syndrome/genetics ; Kallmann Syndrome/metabolism ; Kallmann Syndrome/physiopathology ; Nerve Tissue Proteins/deficiency ; Nerve Tissue Proteins/genetics ; Olfaction Disorders/genetics ; Olfactory Pathways/abnormalities ; Olfactory Pathways/metabolism ; Olfactory Pathways/physiopathology
Chemical Substances	ANOS1 protein, human ; Cell Adhesion Molecules ; Extracellular Matrix Proteins ; Nerve Tissue Proteins
Language	English
Publishing date	2002-08-16
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	808167-0
ISSN	1097-4199 ; 0896-6273
ISSN (online)	1097-4199
ISSN	0896-6273
DOI	10.1016/s0896-6273(02)00720-1
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Zs.MG 92: Show issues

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Article: Hypogonadotropic hypogonadism.

Silveira, Leticia F G / MacColl, Gavin S / Bouloux, Pierre M G

Seminars in reproductive medicine

2002 Volume 20, Issue 4, Page(s) 327–338

Abstract: Hypogonadotropic hypogonadism is characterized by failure of gonadal function secondary to deficient gonadotropin secretion, resulting from either a pituitary or hypothalamic defect, and is commonly seen in association with structural lesions or ... ...

Abstract	Hypogonadotropic hypogonadism is characterized by failure of gonadal function secondary to deficient gonadotropin secretion, resulting from either a pituitary or hypothalamic defect, and is commonly seen in association with structural lesions or functional defects affecting this region. Although the genetic basis for idiopathic hypogonadotropic hypogonadism is largely unknown, mutations in several genes involved in the hypothalamo-pituitary-gonadal axis development and function have recently been implicated in the pathogenesis of this condition. Genes currently recognized to be involved include KAL-1 (associated with X-linked Kallmann Syndrome), gonadotropin-releasing hormone (GnRH) receptor, gonadotropins, pituitary transcription factors (HESX1, LHX3, and PROP-1), orphan nuclear receptors (DAX-1, associated with X-linked adrenal hypoplasia congenital, and SF-1), and three genes also associated with obesity (leptin, leptin receptor, and prohormone convertase 1 [ PC1]). Study of these mutations provides an important contribution in the understanding of the different stages of the reproductive axis development and physiology. Treatment options currently available for puberty induction, maintenance replacement therapy, and fertility induction are considered here. Gametogenesis can be induced with either exogenous gonadotropin or pulsatile GnRH therapy, depending on the etiology.
MeSH term(s)	Aspartic Acid Endopeptidases/genetics ; Female ; Gonadotropin-Releasing Hormone/secretion ; Gonadotropins/genetics ; Gonadotropins/secretion ; Humans ; Hypogonadism/etiology ; Hypogonadism/genetics ; Hypogonadism/therapy ; Leptin/genetics ; Male ; Mutation ; Obesity/genetics ; Proprotein Convertases ; Receptors, Cell Surface/genetics ; Receptors, LHRH/genetics ; Receptors, Leptin
Chemical Substances	Gonadotropins ; Leptin ; Receptors, Cell Surface ; Receptors, LHRH ; Receptors, Leptin ; Gonadotropin-Releasing Hormone (33515-09-2) ; Proprotein Convertases (EC 3.4.21.-) ; Aspartic Acid Endopeptidases (EC 3.4.23.-)
Language	English
Publishing date	2002-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2042479-6
ISSN	1526-4564 ; 1526-8004
ISSN (online)	1526-4564
ISSN	1526-8004
DOI	10.1055/s-2002-36707
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Article: Kallmann's syndrome: molecular pathogenesis.

Hu, Youli / Tanriverdi, Fatih / MacColl, Gavin S / Bouloux, Pierre-Marc G

The international journal of biochemistry & cell biology

2003 Volume 35, Issue 8, Page(s) 1157–1162

Abstract: Kallmann's syndrome (KS) is a genetic condition characterised by hypogonadotrophic hypogonadism (HH) and anosmia; although these are the defining features of the condition, additional neurological and non-neurological sequel may also occur depending on ... ...

Abstract	Kallmann's syndrome (KS) is a genetic condition characterised by hypogonadotrophic hypogonadism (HH) and anosmia; although these are the defining features of the condition, additional neurological and non-neurological sequel may also occur depending on the specific mode of inheritance. KS affects about 1 in 8000 males and 1 in 40,000 females, with most presentations being of the 'sporadic' type. Of the inherited forms, hitherto, only the gene responsible for the X-linked form (X-KS), namely KAL-1, has been identified and the encoded protein, anosmin-1, consists primarily of a whey acidic protein (WAP) and fibronectin-like type III (FnIII) domains which appear to mediate distinctly different protein functions. The WAP/FnIII combination is conserved in anosmins across species and recent studies in rodents and in Caenorhabditis elegans demonstrate that anosmin functions in both axonal targeting and branching. Screening for loci that modify these phenotypes in C. elegans has identified heparan-6-O-sulphotransferase as a key interactor mediating anosmin-1 function. Furthermore, over-expression and loss of function of the C. elegans Kal-1 gene disrupt epidermal morphogenesis, resulting in ventral enclosure and male tail formation defects. These findings provide novel insights into the molecular pathogenesis of X-KS.
MeSH term(s)	Amino Acid Sequence ; Animals ; Extracellular Matrix Proteins/genetics ; Extracellular Matrix Proteins/metabolism ; Female ; Fibronectins/genetics ; Fibronectins/metabolism ; Heparan Sulfate Proteoglycans/metabolism ; Humans ; Kallmann Syndrome/genetics ; Kallmann Syndrome/metabolism ; Male ; Milk Proteins/genetics ; Milk Proteins/metabolism ; Molecular Sequence Data ; Mutation ; Nerve Tissue Proteins/genetics ; Nerve Tissue Proteins/metabolism ; Olfactory Pathways/embryology ; Olfactory Pathways/metabolism
Chemical Substances	ANOS1 protein, human ; Extracellular Matrix Proteins ; Fibronectins ; Heparan Sulfate Proteoglycans ; Milk Proteins ; Nerve Tissue Proteins ; whey acidic proteins
Language	English
Publishing date	2003-07-04
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	1228429-4
ISSN	1878-5875 ; 1357-2725
ISSN (online)	1878-5875
ISSN	1357-2725
DOI	10.1016/s1357-2725(02)00395-3
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Article ; Online: Overexpression of 5-HT2C receptors in forebrain leads to elevated anxiety and hypoactivity.

Kimura, Atsuko / Stevenson, Paula L / Carter, Roderick N / Maccoll, Gavin / French, Karen L / Simons, J Paul / Al-Shawi, Raya / Kelly, Valerie / Chapman, Karen E / Holmes, Megan C

The European journal of neuroscience

2009 Volume 30, Issue 2, Page(s) 299–306

Abstract: The 5-HT(2C) receptor has been implicated in mood and eating disorders. In general, it is accepted that 5-HT(2C) receptor agonists increase anxiety behaviours and induce hypophagia. However, pharmacological analysis of the roles of these receptors is ... ...

Abstract	The 5-HT(2C) receptor has been implicated in mood and eating disorders. In general, it is accepted that 5-HT(2C) receptor agonists increase anxiety behaviours and induce hypophagia. However, pharmacological analysis of the roles of these receptors is hampered by the lack of selective ligands and the complex regulation of receptor isoforms and expression levels. Therefore, the exact role of 5-HT(2C) receptors in mood disorders remain controversial, some suggesting agonists and others suggesting antagonists may be efficacious antidepressants, while there is general agreement that antagonists are beneficial anxiolytics. In order to test the hypothesis that increased 5-HT(2C) receptor expression, and thus increased 5-HT(2C) receptor signalling, is causative in mood disorders, we have undertaken a transgenic approach, directly altering the 5-HT(2C) receptor number in the forebrain and evaluating the consequences on behaviour. Transgenic mice overexpressing 5-HT(2C) receptors under the control of the CaMKIIalpha promoter (C2CR mice) have elevated 5-HT(2C) receptor mRNA levels in cerebral cortex and limbic areas (including the hippocampus and amygdala), but normal levels in the hypothalamus, resulting in > 100% increase in the number of 5-HT(2C) ligand binding sites in the forebrain. The C2CR mice show increased anxiety-like behaviour in the elevated plus-maze, decreased wheel-running behaviour and reduced activity in a novel environment. These behaviours were observed in the C2CR mice without stimulation by exogenous ligands. Our findings support a role for 5-HT(2C) receptor signalling in anxiety disorders. The C2CR mouse model offers a novel and effective approach for studying disorders associated with 5-HT(2C) receptors.
MeSH term(s)	Animals ; Anxiety/genetics ; Anxiety/metabolism ; COS Cells ; Chlorocebus aethiops ; Gene Expression ; Male ; Mice ; Mice, Inbred C57BL ; Mice, Inbred CBA ; Mice, Transgenic ; Motor Activity/physiology ; Prosencephalon/physiology ; Rats ; Receptor, Serotonin, 5-HT2C/biosynthesis ; Receptor, Serotonin, 5-HT2C/genetics
Chemical Substances	Receptor, Serotonin, 5-HT2C
Language	English
Publishing date	2009-07-15
Publishing country	France
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	645180-9
ISSN	1460-9568 ; 0953-816X
ISSN (online)	1460-9568
ISSN	0953-816X
DOI	10.1111/j.1460-9568.2009.06831.x
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