Search Results - "Amaravadi, Lakshmi"

Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography-Tandem Mass Spectrometry: Current State and Future Vision by Neubert, Hendrik, Shuford, Christopher M, Olah, Timothy V, Garofolo, Fabio, Schultz, Gary A, Jones, Barry R, Amaravadi, Lakshmi, Laterza, Omar F, Xu, Keyang, Ackermann, Bradley L

“…Immunoaffinity-mass spectrometry (IA-MS) is an emerging analytical genre with several advantages for profiling and determination of protein biomarkers. Because…”
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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products by Shankar, Gopi, Devanarayan, Viswanath, Amaravadi, Lakshmi, Barrett, Yu Chen, Bowsher, Ronald, Finco-Kent, Deborah, Fiscella, Michele, Gorovits, Boris, Kirschner, Susan, Moxness, Michael, Parish, Thomas, Quarmby, Valerie, Smith, Holly, Smith, Wendell, Zuckerman, Linda A., Koren, Eugen

“…Most biological drug products elicit some level of anti-drug antibody (ADA) response. This antibody response can, in some cases, lead to potentially serious…”
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Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance by Booth, Brian, Arnold, Mark E., DeSilva, Binodh, Amaravadi, Lakshmi, Dudal, Sherri, Fluhler, Eric, Gorovits, Boris, Haidar, Sam H., Kadavil, John, Lowes, Steve, Nicholson, Robert, Rock, Marie, Skelly, Michael, Stevenson, Lauren, Subramaniam, Sriram, Weiner, Russell, Woolf, Eric

“…In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the…”
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Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial by Giovannoni, Gavin, Prof, Gold, Ralf, Prof, Selmaj, Krzysztof, Prof, Havrdova, Eva, Prof, Montalban, Xavier, Prof, Radue, Ernst-Wilhelm, Prof, Stefoski, Dusan, MD, McNeill, Manjit, MSc, Amaravadi, Lakshmi, PhD, Sweetser, Marianne, MD, Elkins, Jacob, MD, O'Neill, Gilmore, MRCPI

“…Summary Background In the SELECT trial, disease activity was reduced in patients with multiple sclerosis who received daclizumab high-yield process (HYP) for…”
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In vivo maintenance of human regulatory T cells during CD25 blockade by Huss, David J, Mehta, Devangi S, Sharma, Akanksha, You, Xiaojun, Riester, Katherine A, Sheridan, James P, Amaravadi, Lakshmi S, Elkins, Jacob S, Fontenot, Jason D

“…Regulatory T cells (Tregs) mediate immune tolerance to self and depend on IL-2 for homeostasis. Treg deficiency, dysfunction, and instability are implicated in…”
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Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies by Ponce, Rafael, Abad, Leslie, Amaravadi, Lakshmi, Gelzleichter, Thomas, Gore, Elizabeth, Green, James, Gupta, Shalini, Herzyk, Danuta, Hurst, Christopher, Ivens, Inge A., Kawabata, Thomas, Maier, Curtis, Mounho, Barbara, Rup, Bonita, Shankar, Gopi, Smith, Holly, Thomas, Peter, Wierda, Dan

“…An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile…”
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-TWEAK Monoclonal Antibody in Patients With Rheumatoid Arthritis by Wisniacki, Nicolas, MD, PhD, Amaravadi, Lakshmi, PhD, Galluppi, Gerald R., PhD, Zheng, Timothy S., PhD, Zhang, Ray, PhD, Kong, Jessica, PhD, Burkly, Linda C., PhD

“…Background Persistent upregulation of signaling by cytokine tumor necrosis factor–like weak inducer of apoptosis (TWEAK) through its receptor fibroblast growth…”
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Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report by Mathews, Joel, Amaravadi, Lakshmi, Eck, Steven, Stevenson, Lauren, Wang, Yow-Ming C., Devanarayan, Viswanath, Allinson, John, Lundsten, Kelly, Gunsior, Michele, Ni, Yan G., Pepin, Marc-Olivier, Gagnon, Audrey, Sheldon, Curtis, Trampont, Paul C., Litwin, Virginia

“…This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held…”
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Functional and structural diversity of the human Dickkopf gene family by Krupnik, Valery E., Sharp, John D., Jiang, Chian, Robison, Keith, Chickering, Troy W., Amaravadi, Lakshmi, Brown, Diane E., Guyot, Deborah, Mays, Gail, Leiby, Kevin, Chang, Belle, Duong, Thao, Goodearl, Andrew D.J., Gearing, David P., Sokol, Sergei Y., McCarthy, Sean A.

“…Wnt proteins influence many aspects of embryonic development, and their activity is regulated by several secreted antagonists, including the Xenopus Dickkopf-1…”
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Mice deficient in fractalkine are less susceptible to cerebral ischemia-reperfusion injury by Soriano, Sulpicio G., Amaravadi, Lakshmi S., Wang, Yanming F., Zhou, Hong, Yu, Gary X., Tonra, James R., Fairchild-Huntress, Victoria, Fang, Qing, Dunmore, Judy H., Huszar, Dennis, Pan, Yang

“…Fractalkine (FKN), also known as neurotactin, is a CX 3C chemokine that exists in both secreted and neuronal membrane-bound forms and is upregulated during…”
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Critical reagents: evolution of WRIB recommendations on critical reagents by Amaravadi, Lakshmi

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In vivo maintenance of human regulatory T cells during CD25 blockade by Huss, David J, Mehta, Devangi S, Sharma, Akanksha, You, Xiaojun, Riester, Katherine A, Sheridan, James P, Amaravadi, Lakshmi S, Elkins, Jacob S, Fontenot, Jason D

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Biomarker measurements: how far have we come and where are we heading? by Amaravadi, Lakshmi

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Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry by Amaravadi, Lakshmi, Palackal, Nisha, Garofolo, Fabio

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Evidence of activation of the Nrf2 pathway in multiple sclerosis patients treated with delayed-release dimethyl fumarate in the Phase 3 DEFINE and CONFIRM studies by Gopal, Sreeja, Mikulskis, Alvydas, Gold, Ralf, Fox, Robert J, Dawson, Katherine T, Amaravadi, Lakshmi

“…Background: Delayed-release dimethyl fumarate (DMF) is an approved oral treatment for relapsing forms of multiple sclerosis (MS). Preclinical studies…”
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Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development by Mikulskis, Alvydas, Yeung, Dave, Subramanyam, Meena, Amaravadi, Lakshmi

“…Humanized monoclonal antibody therapeutics are in many ways indistinguishable from the anti-therapeutic/anti-drug antibodies generated in humans. Therefore,…”
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LBP-22 - Twelve-week treatment with BOS-580, a novel, long-acting Fc-FGF-21 fusion protein, leads to a reduction in liver steatosis, liver injury, and fibrosis in patients with phenotypic NASH: a randomized, blinded, placebo-controlled phase 2A trial by Loomba, Rohit, Kowdley, Kris, Rodriguez, Jose, Kim, Nomita, Alvarez, Alina, Morrow, Linda, Yin, Philip, Amaravadi, Lakshmi, Jeglinski, Brenda, Clawson, Alicia, Chowdhury, Swapan, Basson, Craig, Dumont, Etienne, Svensson, Eric, Odrljin, Tatjana

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Twelve-week treatment with BOS-580, a novel, long-acting Fc-FGF-21 fusion protein, leads to a reduction in liver steatosis, liver injury, and fibrosis in patients with phenotypic NASH: a randomized, blinded, placebo-controlled phase 2A trial by Loomba, Rohit, Kowdley, Kris, Rodriguez, Jose, Kim, Nomita, Alvarez, Alina, Morrow, Linda, Yin, Philip, Amaravadi, Lakshmi, Jeglinski, Brenda, Clawson, Alicia, Chowdhury, Swapan, Basson, Craig, Dumont, Etienne, Svensson, Eric, Odrljin, Tatjana

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New FDA Draft Guidance on Immunogenicity by Parenky, Ashwin, Myler, Heather, Amaravadi, Lakshmi, Bechtold-Peters, Karoline, Rosenberg, Amy, Kirshner, Susan, Quarmby, Valerie

“…A “Late Breaking” session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss…”
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Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays? by Hays, Amanda, Amaravadi, Lakshmi, Fernandez-Metzler, Carmen, King, Lindsay, Mathews, Joel, Ni, Yan, Quadrini, Karen, Tinder, Chunyan, Vazvaei, Faye, Zeng, Jianing

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