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Recommendations on biomarker assay validation (BAV) in tissues by GCC. Bioanalysis. 2025 Apr; 17(7):429-438.
Yuan M, Liu A, Xu B, Sales K, Karnik S, Voelker T, Salha D, Zimmer J, O'Dell M, Gorityala S, Hays A, Lester T, Reynolds G, Tary-Lehmann M, Yu M, Roberge M, Malone K, Patel V, Love I, Lin J, Diaz M, Xu T, Garofolo W, McGregor J, Leskovar A, Kernstock R, Pellerin M, Brown M, Spytko A, Lowes S, Ambrose D, Dufield D, Kane C, Veeramachaneni R, Luna M, Warrino D, Dwivedi V, Xu A, Hyer E, Iles T, Majumdar R, Sikkema D, Thomas E, Carlsson A, Dakappagari N, Riccitelli N, Marco CD, Bouhajib M, Iordachescu A, Sanghvi M, Barton H, Lavelle A, Dompkowski E, Rundlett S, Matys K, Sangster T, Turksma A, Gu W, Liu J, Hoffpauir B, Rocha A, Pirro J, Bergeron J, O'Brien K, Fang X, Dong K, Yamashita J. PMID: 40248960; PMCID: PMC12026151.
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Humans
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16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status. Bioanalysis. 2024 Jun 02; 16(11):505-517.
Zimmer J, Hays A, Lester T, Diaz M, Thomas E, O'Dell M, Hyer E, Tangri S, Dakappagari N, Yuan M, Lavelle A, Karnik S, Liu A, Xu B, Sales K, Gorityala S, Reynolds G, Sangster T, Franckaert D, Love I, Patel V, Roberge M, Lin J, Jerks E, Xu T, Garofolo W, Nadarajah S, Kernstock R, Dufield D, Ambrose D, Warrino D, Luna M, Marco CD, Tudoroniu A, Iordachescu A, Sanghvi M, Barton H, Brown M, Hoffpauir B, Rocha A, Dong K, Yamashita J. PMID: 38864397; PMCID: PMC11299793.
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Humans
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2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization). Bioanalysis. 2024 Apr; 16(7):77-119.
Mora J, Palmer R, Wagner L, Wu B, Partridge M, Sonderegger I, Smeraglia J, Bivi N, Dakappagari N, Diebold S, Garofolo F, Grimaldi C, Kalina W, Kamerud J, Kar S, Marshall JC, Mayer C, Melton A, Merdek K, Nolan K, Picard S, Shao W, Seitzer J, Tanaka Y, Tounekti O, Vigil A, Walravens K, Xu J, Xu W, Xu Y, Yang L, Zhu L, Verthelyi D, Kubiak RJ, Coble K, Gupta S, Abhari MR, Richards S, Song Y, Ullmann M, Calderon B, Cludts I, Gunn GR, Gupta S, Ishii-Watabe A, Manangeeswaran M, Maxfield K, McCush F, O'Day C, Peng K, Poetzl J, Rasamoelisolo M, Saad OM, Scheibner K, Shubow S, Song S, Thacker S. PMID: 38389403; PMCID: PMC11849449.
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2 Fields:
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Analytical assay validation for acute myeloid leukemia measurable residual disease assessment by multiparametric flow cytometry. Cytometry B Clin Cytom. 2023 11; 104(6):426-439.
Tettero JM, Dakappagari N, Heidinga ME, Oussoren-Brockhoff Y, Hanekamp D, Pahuja A, Burns K, Kaur P, Alfonso Z, van der Velden VHJ, Te Marvelde JG, Hobo W, Slomp J, Bachas C, Kelder A, Nguyen K, Cloos J. PMID: 37766649.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Role of Tumor-Infiltrating B Cells in Clinical Outcome of Patients with Melanoma Treated With Dabrafenib Plus Trametinib. Clin Cancer Res. 2021 08 15; 27(16):4500-4510.
Brase JC, Walter RFH, Savchenko A, Gusenleitner D, Garrett J, Schimming T, Varaljai R, Castelletti D, Kim J, Dakappagari N, Schultz K, Robert C, Long GV, Nathan PD, Ribas A, Flaherty KT, Karaszewska B, Schachter J, Sucker A, Schmid KW, Zimmer L, Livingstone E, Gasal E, Schadendorf D, Roesch A. PMID: 34108180; PMCID: PMC9401540.
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PubMed Mentions:
9 Fields:
Translation:
HumansCells
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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays). Bioanalysis. 2021 Mar; 13(6):415-463.
Corsaro B, Yang TY, Murphy R, Sonderegger I, Exley A, Bertholet S, Dakappagari N, Dessy F, Garofolo F, Kierstead L, Koch H, Sarikonda G, Savoie N, Siggers R, Solstad T, Lu Y, Milton M, Marshall JC, DelCarpini J, Gorovits B, Gupta S, Jesaitis L, Kamerud J, Kromminga A, Ma A, McNally J, Yan H, Wu B, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, Rajadhyaksha M, Staack RF, Cherry E, Cludts I, Dahlbäck M, Gunn GR, Ishii-Watabe A, Jawa V, Kubiak R, Partridge M, Petrillo M, Pine SO, Poetzl J, Song S, Stebbins C, Wu Y, Zhang L, Kar S, Liang M, Abhari MR, Schweighardt B, Stubenrauch K, Xu Y. PMID: 33533276.
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PubMed Mentions:
23 Fields:
Translation:
Humans
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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis. 2021 Mar; 13(5):295-361.
Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. PMID: 33511867.
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PubMed Mentions:
7 Fields:
Translation:
Humans
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Multimarker scores of Th1 and Th2 immune cellular profiles in peripheral blood predict response and immune related toxicity with CTLA4 blockade and IFNα in melanoma. Transl Oncol. 2021 Mar; 14(3):101014.
Khunger A, Sarikonda G, Tsau J, Pahuja A, Alfonso Z, Gao J, Laing C, Vaupel C, Dakappagari N, Tarhini AA. PMID: 33450703; PMCID: PMC7810775.
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PubMed Mentions:
7
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Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses. Cytometry B Clin Cytom. 2021 01; 100(1):79-91.
Sarikonda G, Mathieu M, Natalia M, Pahuja A, Xue Q, Pierog PL, Trampont PC, Decman V, Reynolds S, Hanafi LA, Sun YS, Eck S, Hedrick MN, Stewart JJ, Tangri S, Litwin V, Dakappagari N. PMID: 33373096.
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PubMed Mentions:
13 Fields:
Translation:
HumansCells
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Monitoring CAR-T cell kinetics in clinical trials by multiparametric flow cytometry: Benefits and challenges. Cytometry B Clin Cytom. 2021 01; 100(1):72-78.
Sarikonda G, Pahuja A, Kalfoglou C, Burns K, Nguyen K, Ch'en IL, Pollner R, Tangri S, Dakappagari N. PMID: 32573972.
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PubMed Mentions:
10 Fields:
Translation:
HumansCells
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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62). Bioanalysis. 2019 Dec; 11(24):2207-2244.
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. PMID: 31820675.
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PubMed Mentions:
19 Fields:
Translation:
Humans
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Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 01; 88:106283.
Jabbour E, Gökbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. PMID: 31790983.
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PubMed Mentions:
22 Fields:
Translation:
HumansCTClinical Trials
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PD-1/PD-L1 expression and interaction by automated quantitative immunofluorescent analysis show adverse prognostic impact in patients with diffuse large B-cell lymphoma having T-cell infiltration: a study from the International DLBCL Consortium Program. Mod Pathol. 2019 06; 32(6):741-754.
Li L, Sun R, Miao Y, Tran T, Adams L, Roscoe N, Xu B, Manyam GC, Tan X, Zhang H, Xiao M, Tzankov A, Visco C, Dybkaer K, Bhagat G, Tam W, Hsi ED, van Krieken JH, You H, Huh J, Ponzoni M, Ferreri AJM, Møller MB, Piris MA, Zhang M, Winter JN, Medeiros LJ, Rassidakis GZ, Vaupel CA, Li Y, Dakappagari N, Xu-Monette ZY, Young KH. PMID: 30666052.
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PubMed Mentions:
33 Fields:
Translation:
HumansCells
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Quantitative Spatial Profiling of PD-1/PD-L1 Interaction and HLA-DR/IDO-1 Predicts Improved Outcomes of Anti-PD-1 Therapies in Metastatic Melanoma. Clin Cancer Res. 2018 11 01; 24(21):5250-5260.
Johnson DB, Bordeaux J, Kim JY, Vaupel C, Rimm DL, Ho TH, Joseph RW, Daud AI, Conry RM, Gaughan EM, Hernandez-Aya LF, Dimou A, Funchain P, Smithy J, Witte JS, McKee SB, Ko J, Wrangle JM, Dabbas B, Tangri S, Lameh J, Hall J, Markowitz J, Balko JM, Dakappagari N. PMID: 30021908; PMCID: PMC6214750.
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PubMed Mentions:
99 Fields:
Translation:
HumansCells
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Recommendations for clinical biomarker specimen preservation and stability assessments. Bioanalysis. 2017 Apr; 9(8):643-653.
Dakappagari N, Zhang H, Stephen L, Amaravadi L, Khan MU. PMID: 28508714.
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PubMed Mentions:
12 Fields:
Translation:
Humans
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Deep exploration of the immune infiltrate and outcome prediction in testicular cancer by quantitative multiplexed immunohistochemistry and gene expression profiling. Oncoimmunology. 2017; 6(4):e1305535.
Siska PJ, Johnpulle RAN, Zhou A, Bordeaux J, Kim JY, Dabbas B, Dakappagari N, Rathmell JC, Rathmell WK, Morgans AK, Balko JM, Johnson DB. PMID: 28507813; PMCID: PMC5414873.
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PubMed Mentions:
46 Fields:
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Phase I study of BIIB028, a selective heat shock protein 90 inhibitor, in patients with refractory metastatic or locally advanced solid tumors. Clin Cancer Res. 2013 Sep 01; 19(17):4824-31.
Hong D, Said R, Falchook G, Naing A, Moulder S, Tsimberidou AM, Galluppi G, Dakappagari N, Storgard C, Kurzrock R, Rosen LS. PMID: 23873691; PMCID: PMC3935614.
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PubMed Mentions:
14 Fields:
Translation:
HumansCTClinical Trials
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CD80 (B7.1) is expressed on both malignant B cells and nonmalignant stromal cells in non-Hodgkin lymphoma. Cytometry B Clin Cytom. 2012 Mar; 82(2):112-9.
Dakappagari N, Ho SN, Gascoyne RD, Ranuio J, Weng AP, Tangri S. PMID: 22076940.
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PubMed Mentions:
15 Fields:
Translation:
HumansCells
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An investigation into the potential use of serum Hsp70 as a novel tumour biomarker for Hsp90 inhibitors. Biomarkers. 2010 Feb; 15(1):31-8.
Dakappagari N, Neely L, Tangri S, Lundgren K, Hipolito L, Estrellado A, Burrows F, Zhang H. PMID: 19747088.
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PubMed Mentions:
24 Fields:
Translation:
HumansAnimalsCells
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Blockade of CD200 in the presence or absence of antibody effector function: implications for anti-CD200 therapy. J Immunol. 2008 Jan 15; 180(2):699-705.
Kretz-Rommel A, Qin F, Dakappagari N, Cofiell R, Faas SJ, Bowdish KS. PMID: 18178807.
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PubMed Mentions:
42 Fields:
Translation:
HumansAnimalsCells
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In vivo targeting of antigens to human dendritic cells through DC-SIGN elicits stimulatory immune responses and inhibits tumor growth in grafted mouse models. J Immunother. 2007 Oct; 30(7):715-26.
Kretz-Rommel A, Qin F, Dakappagari N, Torensma R, Faas S, Wu D, Bowdish KS. PMID: 17893564.
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PubMed Mentions:
32 Fields:
Translation:
HumansAnimalsCells
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CD200 expression on tumor cells suppresses antitumor immunity: new approaches to cancer immunotherapy. J Immunol. 2007 May 01; 178(9):5595-605.
Kretz-Rommel A, Qin F, Dakappagari N, Ravey EP, McWhirter J, Oltean D, Frederickson S, Maruyama T, Wild MA, Nolan MJ, Wu D, Springhorn J, Bowdish KS. PMID: 17442942.
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PubMed Mentions:
88 Fields:
Translation:
HumansAnimalsCells
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Internalizing antibodies to the C-type lectins, L-SIGN and DC-SIGN, inhibit viral glycoprotein binding and deliver antigen to human dendritic cells for the induction of T cell responses. J Immunol. 2006 Jan 01; 176(1):426-40.
Dakappagari N, Maruyama T, Renshaw M, Tacken P, Figdor C, Torensma R, Wild MA, Wu D, Bowdish K, Kretz-Rommel A. PMID: 16365436.
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PubMed Mentions:
17 Fields:
Translation:
HumansCells
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Intracellular delivery of a novel multiepitope peptide vaccine by an amphipathic peptide carrier enhances cytotoxic T-cell responses in HLA-A*201 mice. J Pept Res. 2005 Feb; 65(2):189-99.
Dakappagari NK, Sundaram R, Rawale S, Liner A, Galloway DR, Kaumaya PT. PMID: 15705163.
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PubMed Mentions:
11 Fields:
Translation:
HumansAnimalsCells
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Protective efficacy of multiepitope human leukocyte antigen-A*0201 restricted cytotoxic T-lymphocyte peptide construct against challenge with human T-cell lymphotropic virus type 1 Tax recombinant vaccinia virus. J Acquir Immune Defic Syndr. 2004 Nov 01; 37(3):1329-39.
Sundaram R, Lynch MP, Rawale S, Dakappagari N, Young D, Walker CM, Lemonnier F, Jacobson S, Kaumaya PT. PMID: 15483462.
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PubMed Mentions:
9 Fields:
Translation:
HumansAnimalsCells
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Conformational HER-2/neu B-cell epitope peptide vaccine designed to incorporate two native disulfide bonds enhances tumor cell binding and antitumor activities. J Biol Chem. 2005 Jan 07; 280(1):54-63.
Dakappagari NK, Lute KD, Rawale S, Steele JT, Allen SD, Phillips G, Reilly RT, Kaumaya PT. PMID: 15507452.
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PubMed Mentions:
25 Fields:
Translation:
HumansAnimalsCells
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A chimeric multi-human epidermal growth factor receptor-2 B cell epitope peptide vaccine mediates superior antitumor responses. J Immunol. 2003 Apr 15; 170(8):4242-53.
Dakappagari NK, Pyles J, Parihar R, Carson WE, Young DC, Kaumaya PT. PMID: 12682258.
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PubMed Mentions:
22 Fields:
Translation:
HumansAnimalsCells
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Synthetic peptides as cancer vaccines. Biopolymers. 2002; 66(3):200-16.
Sundaram R, Dakappagari NK, Kaumaya PT. PMID: 12385038.
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PubMed Mentions:
12 Fields:
Translation:
HumansCells
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Prevention of mammary tumors with a chimeric HER-2 B-cell epitope peptide vaccine. Cancer Res. 2000 Jul 15; 60(14):3782-9.
Dakappagari NK, Douglas DB, Triozzi PL, Stevens VC, Kaumaya PT. PMID: 10919651.
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PubMed Mentions:
34 Fields:
Translation:
HumansAnimalsCells