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Article ; Online: First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus.

Zhou, Xiao-Jian / Lickliter, Jason / Montrond, Maureen / Ishak, Laura / Pietropaolo, Keith / James, Dayle / Belanger, Bruce / Horga, Arantxa / Hammond, Janet

Antimicrobial agents and chemotherapy

2024 , Page(s) e0161523

Abstract: AT-752 is a novel guanosine nucleotide prodrug inhibitor of the dengue virus (DENV) polymerase with sub-micromolar, pan-serotype antiviral activity. This phase 1, double-blind, placebo-controlled, first-in-human study evaluated the safety, tolerability, ... ...

Abstract	AT-752 is a novel guanosine nucleotide prodrug inhibitor of the dengue virus (DENV) polymerase with sub-micromolar, pan-serotype antiviral activity. This phase 1, double-blind, placebo-controlled, first-in-human study evaluated the safety, tolerability, and pharmacokinetics of ascending single and multiple oral doses of AT-752 in healthy subjects. AT-752 was well tolerated when administered as a single dose up to 1,500 mg or when administered as multiple doses up to 750 mg three times daily (TID). No serious adverse events occurred, and the majority of treatment-emergent adverse events were mild in severity and resolved by the end of the study. In those receiving single ascending doses of AT-752, no pharmacokinetic sensitivity was observed in Asian subjects, and no food effect was observed. Plasma exposure of the guanosine nucleoside metabolite AT-273, the surrogate of the active triphosphate metabolite of the drug, increased with increasing dose levels of AT-752 and exhibited a long half-life of approximately 15-25 h. Administration of AT-752 750 mg TID led to a rapid increase in plasma levels of AT-273 exceeding the target Clinical trials: Registered at ClinicalTrials.gov (NCT04722627).
Language	English
Publishing date	2024-03-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.01615-23
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Article: Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY).

Horga, Arantxa / Saenz, Rebecca / Yilmaz, Gürdal / Simón-Campos, Abraham / Pietropaolo, Keith / Stubbings, William J / Collinson, Neil / Ishak, Laura / Zrinscak, Barbara / Belanger, Bruce / Granier, Catherine / Lin, Kai / C Hurt, Aeron / Zhou, Xiao-Jian / Wildum, Steffen / Hammond, Janet

Future virology

2023

Abstract: Aim: ...

Abstract	Aim:
Language	English
Publishing date	2023-11-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2254606-6
ISSN	1746-0808 ; 1746-0794
ISSN (online)	1746-0808
ISSN	1746-0794
DOI	10.2217/fvl-2023-0115
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Article ; Online: A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients.

Yamada, Miko / Miller, Dennis M / Lowe, Melinda / Rowe, Casey / Wood, Dominic / Soyer, H Peter / Byrnes-Blake, Kelly / Parrish-Novak, Julia / Ishak, Laura / Olson, James M / Brandt, Gordon / Griffin, Paul / Spelman, Lynda / Prow, Tarl W

Contemporary clinical trials communications

2021 Volume 23, Page(s) 100830

Abstract: BLZ-100 (tozuleristide) is an intraoperative fluorescent imaging agent that selectively detects malignant tissue and can be used in real time to guide tumor resection. The purpose of this study was to assess the safety, tolerability, and pharmacokinetics ...

Abstract	BLZ-100 (tozuleristide) is an intraoperative fluorescent imaging agent that selectively detects malignant tissue and can be used in real time to guide tumor resection. The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of BLZ-100 and to explore the pharmacodynamics of fluorescence imaging of skin tumors. In this first-in-human study, BLZ-100 was administered intravenously to 21 adult patients 2 days before excising known or suspected skin cancers. Doses were 1, 3, 6, 12, and 18 mg, with 3-6 patients/cohort. Fluorescence imaging was conducted before and up to 48 h after dosing. BLZ-100 was well tolerated. There were no serious adverse events, deaths, or discontinuations due to adverse events, and no maximum tolerated dose (MTD) was identified. Headache (n = 2) and nausea (n = 2) were the only BLZ-100 treatment-related adverse events reported for >1 patient. Median time to maximal serum concentration was <0.5 h. Exposure based on maximal serum concentrations increased in a greater than dose-proportional manner. For intermediate dose-levels (3-12 mg), 4 of 5 basal cell carcinomas and 4 of 4 melanomas were considered positive for BLZ-100 fluorescence. BLZ-100 was well tolerated at all dose levels tested and these results support further clinical testing of this imaging agent in surgical oncology settings. Clinicaltrials.gov: NCT02097875.
Language	English
Publishing date	2021-08-04
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2021.100830
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Article ; Online: Real-time Visualization of Breast Carcinoma in Pathology Specimens From Patients Receiving Fluorescent Tumor-Marking Agent Tozuleristide.

Dintzis, Suzanne M / Hansen, Stacey / Harrington, Kristi M / Tan, Lennart C / Miller, Dennis M / Ishak, Laura / Parrish-Novak, Julia / Kittle, David / Perry, Jeff / Gombotz, Carolyn / Fortney, Tina / Porenta, Stephanie / Hales, Lisa / Calhoun, Kristine E / Anderson, Benjamin O / Javid, Sara H / Byrd, David R

Archives of pathology & laboratory medicine

2018 Volume 143, Issue 9, Page(s) 1076–1083

Abstract: Context.—: Resection of breast carcinoma with adequate margins reduces the risk of local recurrence and reoperation. Tozuleristide (BLZ-100) is an investigational peptide-fluorophore agent that may aid in intraoperative tumor detection and margin ... ...

Abstract	Context.—: Resection of breast carcinoma with adequate margins reduces the risk of local recurrence and reoperation. Tozuleristide (BLZ-100) is an investigational peptide-fluorophore agent that may aid in intraoperative tumor detection and margin assessment. In this study, fluorescence imaging was conducted ex vivo on gross breast pathology specimens. Objectives.—: To determine the potential of tozuleristide to detect breast carcinoma in fresh pathology specimens and the feasibility of fluorescence-guided intraoperative pathology assessment of surgical margins. Design.—: Twenty-three patients received an intravenous bolus dose of 6 or 12 mg of tozuleristide at least 1 hour before surgery. Fifteen lumpectomy and 12 mastectomy specimens were evaluated for fluorescence by the site's clinical pathology staff using the SIRIS, an investigational near-infrared imaging device. The breast tissue was then processed per usual procedures. Fluorescent patterns were correlated with the corresponding hematoxylin-eosin-stained sections. Clinical pathology reports were used to correlate fluorescent signal to grade, histotype, prognostic marker status, and margin measurements. Results.—: Tozuleristide fluorescence was readily observed in invasive and in situ breast carcinoma specimens. Most invasive carcinomas were bright and focal, whereas in situ lesions demonstrated a less intense, more diffuse pattern. Tozuleristide was detected in ductal and lobular carcinomas with a similar fluorescent pattern. Fluorescence was detected in high- and low-grade lesions, and molecular marker/hormone receptor status did not affect signal. Fluorescence could be used to identify the relationship of carcinoma to margins intraoperatively. Conclusions.—: Tumor targeting with tozuleristide allowed visual real-time distinction between pathologically confirmed breast carcinoma and normal tissue.
MeSH term(s)	Breast Carcinoma In Situ/diagnostic imaging ; Breast Carcinoma In Situ/pathology ; Breast Carcinoma In Situ/surgery ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/surgery ; Carcinoma, Ductal, Breast/diagnostic imaging ; Carcinoma, Ductal, Breast/pathology ; Carcinoma, Ductal, Breast/surgery ; Carcinoma, Lobular/diagnostic imaging ; Carcinoma, Lobular/pathology ; Carcinoma, Lobular/surgery ; Female ; Fluorescent Dyes ; Humans ; Indocyanine Green/analogs & derivatives ; Intraoperative Care/methods ; Margins of Excision ; Mastectomy ; Mastectomy, Segmental ; Neoplasm Invasiveness/diagnostic imaging ; Neoplasm Invasiveness/pathology ; Prognosis ; Scorpion Venoms
Chemical Substances	Fluorescent Dyes ; Scorpion Venoms ; Chlorotoxin (06UV5RFW57) ; tozuleristide (835UH424TU) ; Indocyanine Green (IX6J1063HV)
Language	English
Publishing date	2018-12-14
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2018-0197-OA
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Article ; Online: Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults With Newly Diagnosed or Recurrent Gliomas.

Patil, Chirag G / Walker, David G / Miller, Dennis M / Butte, Pramod / Morrison, Beth / Kittle, David S / Hansen, Stacey J / Nufer, Kaitlin L / Byrnes-Blake, Kelly A / Yamada, Miko / Lin, Lynlee L / Pham, Kim / Perry, Jeff / Parrish-Novak, Julia / Ishak, Laura / Prow, Tarl / Black, Keith / Mamelak, Adam N

Neurosurgery

2019 Volume 85, Issue 4, Page(s) E641–E649

Abstract: Background: Fluorescence-guided surgery (FGS) can improve extent of resection in gliomas. Tozuleristide (BLZ-100), a near-infrared imaging agent composed of the peptide chlorotoxin and a near-infrared fluorophore indocyanine green, is a candidate ... ...

Abstract	Background: Fluorescence-guided surgery (FGS) can improve extent of resection in gliomas. Tozuleristide (BLZ-100), a near-infrared imaging agent composed of the peptide chlorotoxin and a near-infrared fluorophore indocyanine green, is a candidate molecule for FGS of glioma and other tumor types. Objective: To perform a phase 1 dose-escalation study to characterize the safety, pharmacokinetics, and fluorescence imaging of tozuleristide in adults with suspected glioma. Methods: Patients received a single intravenous dose of tozuleristide 3 to 29 h before surgery. Fluorescence images of tumor and cavity in Situ before and after resection and of excised tissue ex Vivo were acquired, along with safety and pharmacokinetic measures. Results: A total of 17 subjects received doses between 3 and 30 mg. No dose-limiting toxicity was observed, and no reported adverse events were considered related to tozuleristide. At doses of 9 mg and above, the terminal serum half-life for tozuleristide was approximately 30 min. Fluorescence signal was detected in both high- and low-grade glial tumors, with high-grade tumors generally showing greater fluorescence intensity compared to lower grade tumors. In high-grade tumors, signal intensity increased with increased dose levels of tozuleristide, regardless of the time of dosing relative to surgery. Conclusion: These results support the safety of tozuleristide at doses up to 30 mg and suggest that tozuleristide imaging may be useful for FGS of gliomas.
MeSH term(s)	Adult ; Aged ; Brain Neoplasms/diagnostic imaging ; Brain Neoplasms/metabolism ; Brain Neoplasms/surgery ; Dose-Response Relationship, Drug ; Female ; Fluorescent Dyes/administration & dosage ; Fluorescent Dyes/pharmacokinetics ; Glioma/diagnostic imaging ; Glioma/metabolism ; Glioma/surgery ; Humans ; Indocyanine Green/administration & dosage ; Indocyanine Green/analogs & derivatives ; Indocyanine Green/pharmacokinetics ; Injections, Intravenous ; Male ; Middle Aged ; Neoplasm Recurrence, Local/diagnostic imaging ; Neoplasm Recurrence, Local/metabolism ; Neoplasm Recurrence, Local/surgery ; Optical Imaging/methods ; Scorpion Venoms/administration & dosage ; Scorpion Venoms/pharmacokinetics
Chemical Substances	Fluorescent Dyes ; Scorpion Venoms ; tozuleristide (835UH424TU) ; Indocyanine Green (IX6J1063HV)
Language	English
Publishing date	2019-05-08
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	135446-2
ISSN	1524-4040 ; 0148-396X
ISSN (online)	1524-4040
ISSN	0148-396X
DOI	10.1093/neuros/nyz125
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Zs.A 1424: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency.

Lovejoy, Amy E / Reynolds, Tom C / Visich, Jennifer E / Butine, Michael D / Young, Guy / Belvedere, Melissa A / Blain, Rachelle C / Pederson, Susan M / Ishak, Laura M / Nugent, Diane J

Blood

2006 Volume 108, Issue 1, Page(s) 57–62

Abstract: Congenital factor XIII (FXIII) deficiency is associated with a tendency for severe bleeding, a risk for spontaneous abortion, and a high rate of spontaneous intracranial hemorrhage. This phase 1 escalating-dose study was developed to evaluate the safety ... ...

Abstract	Congenital factor XIII (FXIII) deficiency is associated with a tendency for severe bleeding, a risk for spontaneous abortion, and a high rate of spontaneous intracranial hemorrhage. This phase 1 escalating-dose study was developed to evaluate the safety and pharmacokinetics of a single administration of human recombinant FXIII-A2 (rFXIII-A2) homodimer in adults with congenital FXIII deficiency. Pharmacokinetics and activity of rXIII and changes in endogenous B subunit levels were assessed. Recombinant FXIII-A2 homodimer were complexed with endogenous FXIII-B subunits to form an FXIII-A2B2 heterotetramer with a half-life of 8.5 days, similar to that of endogenous FXIII. The median dose response was a 2.4% increase in FXIII activity based on unit per kilogram rFXIII administered. After the administration of rFXIII-A2, clot solubility normalized as measured by clot lysis in urea. Clot strength and resistance to fibrinolysis, as assessed by thromboelastography, also improved. Safety reviews were conducted before each dose escalation; no serious adverse events, including bleeding or thrombosis, were noted during the study. In addition, there was no evidence of the generation of specific antibodies to rFXIII or yeast proteins. Recombinant FXIII appears to be a safe and potentially effective alternative for FXIII replacement in patients with FXIII deficiency.
MeSH term(s)	Adult ; Aged ; Blood Coagulation/drug effects ; Blood Coagulation Tests ; Dimerization ; Dose-Response Relationship, Drug ; Drug-Related Side Effects and Adverse Reactions ; Factor XIII/analysis ; Factor XIII Deficiency/congenital ; Factor XIII Deficiency/drug therapy ; Factor XIII Deficiency/immunology ; Factor XIIIa/administration & dosage ; Factor XIIIa/adverse effects ; Factor XIIIa/pharmacokinetics ; Female ; Humans ; Male ; Middle Aged ; Pilot Projects ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/adverse effects ; Recombinant Proteins/pharmacokinetics ; Solubility ; Thrombelastography ; Time Factors
Chemical Substances	Recombinant Proteins ; recombinant factor XIII-A2 ; Factor XIII (9013-56-3) ; factor XIIIb (97089-56-0) ; Factor XIIIa (EC 2.3.2.13)
Language	English
Publishing date	2006-03-23
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2005-02-0788
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Article: Evaluation of the BTA Tests for the Detection of Bilharzial Related Bladder Cancer: The Cairo Experience

Khaled, Hussein M. / Abdel-Salam, Ibrahim / Abdel-Gawad, Manar / Metwally, Ayman / El-Demerdash, Salwa / El-Didi, Mounir / Morsi, Ahmed / Ishak, Laura / Ishak, Laura

European Urology

2000 Volume 39, Issue 1, Page(s) 91–94

Abstract: Objective: To evaluate the clinical performance of the BTA stat test and the BTA TRAK assay in the diagnosis of bilharzia–related bladder cancer and to calculate a new ‘Egyptian’ cut–off value for the BTA TRAK (quantitative) assay. Methods: Urine samples ...

Institution	Cairo National Cancer Institute, Cairo, Egypt Bion Diagnostic Sciences, Redmond, Wash., USA
Abstract	Objective: To evaluate the clinical performance of the BTA stat test and the BTA TRAK assay in the diagnosis of bilharzia–related bladder cancer and to calculate a new ‘Egyptian’ cut–off value for the BTA TRAK (quantitative) assay. Methods: Urine samples of 149 individuals were tested for the presence of the human complement factor H–related protein, the antigen detected by the BTA stat and BTA TRAK tests. The group consisted of 53 healthy volunteers, 20 patients with active bilharziasis, 11 patients with other urologic disorders including prostate cancer, and 65 patients with histologically proven bladder cancer. All samples were obtained prior to surgery or therapy. Results: The BTA stat test was positive in 64 of 65 samples from patients with bladder cancer, for an overall sensitivity of 99%. With a BTA TRAK assay cut–off of 60 U/ml (set at 97% specificity in the healthy population), the sensitivity of the TRAK assay was 94%. There was no statistically significant difference between the sensitivities of the two BTA tests in patients diagnosed with squamous cell carcinoma and those with transitional cell carcinoma. The overall specificity of the BTA stat test was 67% ranging from 15% in patients with bilharziasis to 94% in healthy volunteers. The overall specificity of the TRAK assay was 66%, again with negative results in 15% of the patients with bilharziasis. Conclusions: The BTA stat test and TRAK tests are extremely sensitive in the detection of bladder cancer in the Egyptian population. Positive results (85%) are also observed in patients with active bilharziasis, which often leads to bladder cancer. Longitudinal follow–up of these positive cases is needed to determine whether these positive results are false or predictive of bladder cancer.
Keywords	Bladder cancer ; Bladder neoplasms ; BTA stat test ; BTA TRAK test ; Bilharziasis
Language	English
Publishing date	2000-12-22
Publisher	S. Karger AG
Publishing place	Basel, Switzerland
Document type	Article
Note	Bladder and Urothelial Cancer
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1159/000052418
Database	Karger publisher's database

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Zs.A 1247: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 294: Show issues

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Article: Comparison of the BTA ; Test with Voided Urine Cytology and Bladder Wash Cytology in the Diagnosis and Monitoring of Bladder Cancer

Leyh, Herbert / Marberger, Michael / Conort, Pierre / Sternberg, Cora / Pansadoro, Vito / Pagano, Francesco / Bassi, Pierfrancesco / Boccon-Gibod, Laurent / Ravery, Vincent / Treiber, Uwe / Ishak, Laura

European Urology

1999 Volume 35, Issue 1, Page(s) 52–56

Abstract: Objective: To compare the BTA statTM test (BTA stat), a new one-step immunochromatographic assay that can be performed in the urologist’s office or in the laboratory, to voided urine cytology and bladder wash cytology (cytology) in the diagnosis and ... ...

Institution	Technical University of Munich, Munich, Germany University of Vienna, Vienna, Austria Hôpital Pitié-Salpêtrière, Paris, France Pio XI Clinic, Rome, Italy University of Padova, Padova, Italy Hôpital Bichat, Paris, France, and Bard Diagnostic Sciences, Redmond, Wash., USA
Abstract	Objective: To compare the BTA statTM test (BTA stat), a new one-step immunochromatographic assay that can be performed in the urologist’s office or in the laboratory, to voided urine cytology and bladder wash cytology (cytology) in the diagnosis and monitoring of cancer of the bladder (BC). Methods: BTA stat and cytology were performed in a double-blinded, prospective, clinical study on specimens from 240 subjects (68 females; mean age of subjects: 64 years) suspected of having BC. Results: In 107 subjects with final diagnoses of BC confirmed by cystoscopy or cystoscopy and biopsy, the overall sensitivities of BTA stat and cytology were 65 and 33%, respectively. For tumor grades I, II, and III, the sensitivities of BTA stat were 39, 67 and 83%, respectively. Those of cytology were 4, 20 and 69%. Nine subjects had a diagnosis of ‘suspicious for bladder cancer’. The specificities of BTA stat and cytology in the 124 subjects without BC were 64 and 99%, respectively. In the subjects with a history of BC (n = 74), the specificities of BTA stat and cytology were 72 and 99%, respectively. The specificity of BTA stat was lower in subjects with benign or malignant genitourinary disease other than BC (46%) than in subjects without genitourinary disease (71%). Conclusions: The BTA stat test is considerably more sensitive than cytology in the detection of BC and can replace cytology as an adjunct to cystoscopy in the diagnosis and follow-up of patients with BC. However, due to low specificity, BTA stat should not be used without first ruling out potential interferences such as infections, renal disease and cancer, or genitourinary trauma.
Keywords	Bladder cancer ; Bladder neoplasms ; BTA stat ; test ; Cytology ; Tumor-associated antigen
Language	English
Publishing date	1999-02-08
Publisher	S. Karger AG
Publishing place	Basel, Switzerland
Document type	Article
Note	Clinical Paper
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1159/000019819
Database	Karger publisher's database

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