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Article ; Online: Accelerating therapeutics development during a pandemic: population pharmacokinetics of the long-acting antibody combination AZD7442 (tixagevimab/cilgavimab) in the prophylaxis and treatment of COVID-19.

Clegg, Lindsay E / Stepanov, Oleg / Schmidt, Henning / Tang, Weifeng / Zhang, Huixia / Webber, Chris / Cohen, Taylor S / Esser, Mark T / Någård, Mats

Antimicrobial agents and chemotherapy

2024 Volume 68, Issue 5, Page(s) e0158723

Abstract: AZD7442 is a combination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-neutralizing antibodies, tixagevimab and cilgavimab, developed for pre-exposure prophylaxis (PrEP) and treatment of coronavirus disease 2019 (COVID-19). Using data ... ...

Abstract	AZD7442 is a combination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-neutralizing antibodies, tixagevimab and cilgavimab, developed for pre-exposure prophylaxis (PrEP) and treatment of coronavirus disease 2019 (COVID-19). Using data from eight clinical trials, we describe a population pharmacokinetic (popPK) model of AZD7442 and show how modeling of "interim" data accelerated decision-making during the COVID-19 pandemic. The final model was a two-compartmental distribution model with first-order absorption and elimination, including standard allometric exponents for the effect of body weight on clearance and volume. Other covariates included were as follows: sex, age >65 years, body mass index ≥30 kg/m
MeSH term(s)	Humans ; SARS-CoV-2/drug effects ; COVID-19 Drug Treatment ; Female ; Male ; Middle Aged ; Antibodies, Monoclonal, Humanized/pharmacokinetics ; Antibodies, Monoclonal, Humanized/therapeutic use ; Aged ; Adult ; COVID-19/prevention & control ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/therapeutic use ; Young Adult ; Adolescent ; Antibodies, Neutralizing/blood
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antiviral Agents ; Antibodies, Neutralizing
Language	English
Publishing date	2024-03-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.01587-23
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Article ; Online: Cardiac and vascular serious adverse events following tixagevimab-cilgavimab - Author's reply.

Maselkar, Sheetal / Kiazand, Alexandre / Templeton, Alison / Montgomery, Hugh / Esser, Mark T

The Lancet. Respiratory medicine

2022 Volume 11, Issue 1, Page(s) e7–e8

MeSH term(s)	Humans ; Antibodies, Monoclonal
Chemical Substances	tixagevimab ; cilgavimab (1KUR4BN70F) ; Antibodies, Monoclonal
Language	English
Publishing date	2022-12-12
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	2686754-0
ISSN	2213-2619 ; 2213-2600
ISSN (online)	2213-2619
ISSN	2213-2600
DOI	10.1016/S2213-2600(22)00450-7
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Article: Safety, Efficacy and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Treatment of Mild-to-Moderate COVID-19: 15-Month Final Analysis of the TACKLE Trial.

Hobbs, F D Richard / Montgomery, Hugh / Padilla, Francisco / Simón-Campos, Jesus Abraham / Arbetter, Douglas / Seegobin, Seth / Kiazand, Alexandre / Streicher, Katie / Martinez-Alier, Nuria / Cohen, Taylor S / Esser, Mark T

Infectious diseases and therapy

2024 Volume 13, Issue 3, Page(s) 521–533

Abstract: Introduction: In the phase 3 TACKLE study, outpatient treatment with AZD7442 (tixagevimab/cilgavimab) was well tolerated and significantly reduced progression to severe disease or death through day 29 in adults with mild-to-moderate coronavirus disease ... ...

Abstract	Introduction: In the phase 3 TACKLE study, outpatient treatment with AZD7442 (tixagevimab/cilgavimab) was well tolerated and significantly reduced progression to severe disease or death through day 29 in adults with mild-to-moderate coronavirus disease 2019 (COVID-19) at the primary analysis. Here, we report data from the final analysis of the TACKLE study, performed after approximately 15 months' follow-up. Methods: Eligible participants were randomized 1:1 and dosed within 7 days of symptom onset with 600 mg intramuscular AZD7442 (n = 456; 300 mg tixagevimab/300 mg cilgavimab) or placebo (n = 454). Results: Severe COVID-19 or death through day 29 occurred in 4.4% and 8.8% of participants who received AZD7442 or placebo, a relative risk reduction (RRR) of 50.4% [95% confidence interval (CI) 14.4, 71.3; p = 0.0096]; among participants dosed within 5 days of symptom onset, the RRR was 66.9% (95% CI 31.1, 84.1; p = 0.002). Death from any cause or hospitalization for COVID-19 complications or sequelae through day 169 occurred in 5.0% of participants receiving AZD7442 versus 9.7% receiving placebo, an RRR of 49.2% (95% CI 14.7, 69.8; p = 0.009). Adverse events occurred in 55.5% and 55.9% of participants who received AZD7442 or placebo, respectively, and were mostly mild or moderate in severity. Serious adverse events occurred in 10.2% and 14.4% of participants who received AZD7442 or placebo, respectively, and deaths occurred in 1.8% of participants in both groups. Serum concentration-time profiles recorded over 457 days were similar for AZD7442, tixagevimab, and cilgavimab, and were consistent with the extended half-life reported for AZD7442 (approx. 90 days). Conclusions: AZD7442 reduced the risk of progression to severe COVID-19, hospitalization, and death, was well tolerated through 15 months, and exhibited predictable pharmacokinetics in outpatients with mild-to-moderate COVID-19. These data support the long-term safety of using long-acting monoclonal antibodies to treat COVID-19. Trial registration: Clinicaltrials.gov, NCT04723394. ( https://clinicaltrials.gov/study/NCT04723394 .
Language	English
Publishing date	2024-02-25
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-024-00931-4
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Article: Efficacy, Safety, and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Prevention of Symptomatic COVID-19: 15-Month Final Analysis of the PROVENT and STORM CHASER Trials.

Levin, Myron J / Ustianowski, Andrew / De Wit, Stephane / Beavon, Rohini / Thissen, Jesse / Seegobin, Seth / Dey, Kanika / Near, Karen A / Streicher, Katie / Kiazand, Alexandre / Esser, Mark T

Infectious diseases and therapy

2024

Language	English
Publishing date	2024-05-04
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-024-00970-x
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Article ; Online: Author Correction: Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants.

Wilkins, Deidre / Yuan, Yuan / Chang, Yue / Aksyuk, Anastasia A / Núñez, Beatriz Seoane / Wählby-Hamrén, Ulrika / Zhang, Tianhui / Abram, Michael E / Leach, Amanda / Villafana, Tonya / Esser, Mark T

Nature medicine

2024

Language	English
Publishing date	2024-04-22
Publishing country	United States
Document type	Published Erratum
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-024-03006-6
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Article ; Online: Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants.

Nature medicine

2023 Volume 29, Issue 5, Page(s) 1172–1179

Abstract: Nirsevimab is an extended half-life monoclonal antibody specific for the prefusion conformation of the respiratory syncytial virus (RSV) F protein, which has been studied in preterm and full-term infants in the phase 2b and phase 3 MELODY trials. We ... ...

Abstract	Nirsevimab is an extended half-life monoclonal antibody specific for the prefusion conformation of the respiratory syncytial virus (RSV) F protein, which has been studied in preterm and full-term infants in the phase 2b and phase 3 MELODY trials. We analyzed serum samples collected from 2,143 infants during these studies to characterize baseline levels of RSV-specific immunoglobulin G antibodies and neutralizing antibodies (NAbs), duration of RSV NAb levels following nirsevimab administration, the risk of RSV exposure during the first year of life and the infant's adaptive immune response to RSV following nirsevimab administration. Baseline RSV antibody levels varied widely; consistent with reports that maternal antibodies are transferred late in the third trimester, preterm infants had lower baseline RSV antibody levels than full-term infants. Nirsevimab recipients had RSV NAb levels >140-fold higher than baseline at day 31 and remained >50-fold higher at day 151 and >7-fold higher at day 361. Similar seroresponse rates to the postfusion form of RSV F protein in nirsevimab recipients (68-69%) compared with placebo recipients (63-70%; not statistically significant) suggest that while nirsevimab protects from RSV disease, it still allows an active immune response. In summary, nirsevimab provided sustained, high levels of NAb throughout an infant's first RSV season and prevented RSV disease while allowing the development of an immune response to RSV.
MeSH term(s)	Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Respiratory Syncytial Virus Infections/drug therapy ; Respiratory Syncytial Virus Infections/metabolism ; Antibodies, Viral ; Respiratory Syncytial Virus, Human ; Antibodies, Neutralizing ; Immunity
Chemical Substances	nirsevimab (VRN8S9CW5V) ; Antibodies, Viral ; Antibodies, Neutralizing
Language	English
Publishing date	2023-04-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-023-02316-5
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Article: Outpatient Treatment with AZD7442 (Tixagevimab/Cilgavimab) Prevented COVID-19 Hospitalizations over 6 Months and Reduced Symptom Progression in the TACKLE Randomized Trial.

Hobbs, F D Richard / Montgomery, Hugh / Padilla, Francisco / Simón-Campos, Jesus Abraham / Kim, Kenneth / Arbetter, Douglas / Padilla, Kelly W / Reddy, Venkatesh Pilla / Seegobin, Seth / Streicher, Katie / Templeton, Alison / Viani, Rolando M / Johnsson, Eva / Koh, Gavin C K W / Esser, Mark T

Infectious diseases and therapy

2023 Volume 12, Issue 9, Page(s) 2269–2287

Abstract: Introduction: We assessed effects of AZD7442 (tixagevimab/cilgavimab) on deaths from any cause or hospitalizations due to coronavirus disease 2019 (COVID-19) and symptom severity and longer-term safety in the TACKLE adult outpatient treatment study.: ... ...

Abstract	Introduction: We assessed effects of AZD7442 (tixagevimab/cilgavimab) on deaths from any cause or hospitalizations due to coronavirus disease 2019 (COVID-19) and symptom severity and longer-term safety in the TACKLE adult outpatient treatment study. Methods: Participants received 600 mg AZD7442 (n = 452) or placebo (n = 451) ≤ 7 days of COVID-19 symptom onset. Results: Death from any cause or hospitalization for COVID-19 complications or sequelae through day 169 (key secondary endpoint) occurred in 20/399 (5.0%) participants receiving AZD7442 versus 40/407 (9.8%) receiving placebo [relative risk reduction (RRR) 49.1%; 95% confidence interval (CI) 14.5, 69.7; p = 0.009] or 50.7% (95% CI 17.5, 70.5; p = 0.006) after excluding participants unblinded before day 169 for consideration of vaccination). AZD7442 reduced progression of COVID-19 symptoms versus placebo through to day 29 (RRR 12.5%; 95% CI 0.5, 23.0) and improved most symptoms within 1-2 weeks. Over median safety follow-up of 170 days, adverse events occurred in 174 (38.5%) and 196 (43.5%) participants receiving AZD7442 or placebo, respectively. Cardiac serious adverse events occurred in two (0.4%) and three (0.7%) participants receiving AZD7442 or placebo, respectively. Conclusions: AZD7442 was well tolerated and reduced hospitalization and mortality through 6 months, and symptom burden through 29 days, in outpatients with mild-to-moderate COVID-19. Clinical trial registration: Clinicaltrials.gov, NCT04723394. ( https://beta. Clinicaltrials: gov/study/NCT04723394 ).
Language	English
Publishing date	2023-09-26
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-023-00861-7
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Article ; Online: Safety, Tolerability and Pharmacokinetics of Half-Life Extended Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Monoclonal Antibodies AZD7442 (Tixagevimab-Cilgavimab) in Healthy Adults.

Forte-Soto, Pablo / Albayaty, Muna / Brooks, Dennis / Arends, Rosalinda H / Tillinghast, John / Aksyuk, Anastasia A / Bouquet, Jerome / Chen, Cecil / Gebre, Asfiha / Kubiak, Robert J / Pilla Reddy, Venkatesh / Seegobin, Seth / Streicher, Katie / Templeton, Alison / Esser, Mark T

The Journal of infectious diseases

2023 Volume 227, Issue 10, Page(s) 1153–1163

Abstract: Background: AZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific neutralizing monoclonal antibodies (tixagevimab and cilgavimab).: Methods: This phase 1, first-in-human, randomized, ... ...

Abstract	Background: AZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific neutralizing monoclonal antibodies (tixagevimab and cilgavimab). Methods: This phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study evaluated AZD7442 administered intramuscularly (300 mg) or intravenously (300, 1000, or 3000 mg) in healthy adults (aged 18-55 years). The primary end point was safety and tolerability. Secondary end points included pharmacokinetics and antidrug antibodies. Results: Between 18 August and 16 October 2020, a total of 60 participants were enrolled; 50 received AZD7442, and 10 received placebo. Adverse events (all of mild or moderate intensity) occurred in 26 participants (52.0%) in the AZD7442 groups and 8 (80.0%) in the placebo group. No infusion or injection site or hypersensitivity reactions occurred. Tixagevimab and cilgavimab had mean half-lives of approximately 90 days (range, 87.0-95.3 days for tixagevimab and 79.8--91.1 days for cilgavimab) and similar pharmacokinetic profiles over the 361-day study period. SARS-CoV-2-specific neutralizing antibody titers provided by AZD7442 were maintained above those in plasma from convalescent patients with coronavirus disease 2019 (COVID-19). Conclusions: AZD7442 was well tolerated in healthy adults, showing a favorable safety profile across all doses. Depending on the SARS-CoV-2 variant, pharmacokinetic analyses suggest the AZD7442 could offer protection for ≥6 months against symptomatic COVID-19 after a single 300-mg intramuscular administration. Clinical trials registration: NCT04507256.
MeSH term(s)	Humans ; Adult ; SARS-CoV-2 ; COVID-19 ; Half-Life ; Antibodies, Monoclonal ; Antibodies, Neutralizing ; Double-Blind Method ; Antibodies, Viral
Chemical Substances	tixagevimab ; cilgavimab and tixagevimab drug combination ; cilgavimab (1KUR4BN70F) ; Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral
Language	English
Publishing date	2023-02-11
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiad014
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Article: Validation and performance of a multiplex serology assay to quantify antibody responses following SARS-CoV-2 infection or vaccination.

Wilkins, Deidre / Aksyuk, Anastasia A / Ruzin, Alexey / Tuffy, Kevin M / Green, Tina / Greway, Rebecca / Fikes, Brittany / Bonhomme, Cyrille J / Esser, Mark T / Kelly, Elizabeth J

Clinical & translational immunology

2022 Volume 11, Issue 4, Page(s) e1385

Abstract: Objectives: Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS-CoV-2, electrochemiluminescent (ECL) serology assay; ...

Abstract	Objectives: Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS-CoV-2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS-CoV-2 immunoassays; and present calibration results for two SARS-CoV-2 reference standards. Methods: Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS-CoV-2 polymerase chain reaction (PCR)-positive patient samples. Assay concordance to the established Roche Elecsys® Anti-SARS-CoV-2 immunoassay and a live-virus microneutralisation (MN) assay was evaluated. Results: Standard curves demonstrated the assay can quantify SARS-CoV-2 antibody levels over a broad range. Assay precision (10.2-15.1% variability), dilutional linearity (≤ 1.16-fold bias per 10-fold increase in dilution), ruggedness (0.89-1.18 overall fold difference), relative accuracy (107-118%) and robust selectivity (102-104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL Conclusions: The multiplex SARS-CoV-2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS-CoV-2 antigens in human sera, supporting its use in clinical trials and sero-epidemiology studies.
Language	English
Publishing date	2022-04-26
Publishing country	Australia
Document type	Journal Article
ZDB-ID	2694482-0
ISSN	2050-0068
ISSN	2050-0068
DOI	10.1002/cti2.1385
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Article ; Online: Generalized ROC methods for immunogenicity data analysis of vaccine phase I studies in a seropositive population.

Yu, Li / Esser, Mark T / Falloon, Judith / Villafana, Tonya / Yang, Harry

Human vaccines & immunotherapeutics

2018 Volume 14, Issue 11, Page(s) 2692–2700

Abstract: Immunogenicity data from phase 1 vaccine studies can be difficult to interpret, especially in seropositive populations and when multiple assays are used. We developed 3 statistical methods (Youden index [YI] threshold, receiver-operating characteristic ... ...

Abstract	Immunogenicity data from phase 1 vaccine studies can be difficult to interpret, especially in seropositive populations and when multiple assays are used. We developed 3 statistical methods (Youden index [YI] threshold, receiver-operating characteristic relative to baseline [ROC-B], and ROC of postdose levels [ROC-P]) to characterize complex immunogenicity data by assessing the proportion of a study population that achieved values above thresholds. The YI method calculates a single threshold per assay. Both ROC methods construct ROC curves for individual assays and surfaces for assay combinations to assess degree of separation of postdose values from a reference distribution; the ROC-B method uses overall predose values as the reference distribution and the ROC-P method uses pooled postdose values. All methods are applicable to a seropositive population with overlapping distributions of baseline and postdose measurements and can evaluate results of multiple assays jointly. The ROC-P method is also applicable when postdose levels are fully separated from baseline levels, as is common in a seronegative population. These methods were demonstrated using data from a phase 1a study of respiratory syncytial virus vaccines formulated with and without an adjuvant in a seropositive population of adults aged ≥60 years. All 3 methods provided a comprehensive assessment of vaccine immunogenicity effects with results presented in easily interpretable formats. In the example data, the methods demonstrated antigen dose response trend and contribution of adjuvant to response in multiple assays individually and jointly where optimal responses in assay combinations (humoral and cellular) are important.
Language	English
Publishing date	2018-07-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2018.1489191
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