Publications by authors named "Flora Berisha"

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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Lina Loo, Shannon Harris, Mark Milton, Meena, Wibke Lembke, Flora Berisha

Bioanalysis· June 2022

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2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Sarah Hersey, Steve Keller, Joel Mathews, Lindsay King, Abbas Bandukwala, Flora Berisha

Bioanalysis· May 2022

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FLT3 inhibitors added to induction therapy induce deeper remissions.
Mark Levis, Wenge Shi, Ken Chang, Christian Laing, Reinhold Pollner, Flora Berisha

Blood· January 2020

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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Shalini Gupta, Susan Richards, Lakshmi Amaravadi, Steven Piccoli, Binodh Desilva, Flora Berisha

Bioanalysis· December 2017

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, Herbert Birnboeck, Albert Torri, Flora Berisha

Bioanalysis· December 2016

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The γ-Secretase Modulator, BMS-932481, Modulates Aβ Peptides in the Plasma and Cerebrospinal Fluid of Healthy Volunteers.
Holly D Soares, Maciej Gasior, Jeremy H Toyn, Jun-Sheng Wang, Quan Hong, Flora Berisha

J Pharmacol Exp Ther· July 2016

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Robust Translation of γ-Secretase Modulator Pharmacology across Preclinical Species and Human Subjects.
Jeremy H Toyn, Kenneth M Boy, Joseph Raybon, Jere E Meredith, Alan S Robertson, Flora Berisha

J Pharmacol Exp Ther· July 2016

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Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
Darshana Jani, John Allinson, Flora Berisha, Kyra J Cowan, Viswanath Devanarayan

AAPS J· January 2016

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Divergent CSF τ alterations in two common tauopathies: Alzheimer's disease and progressive supranuclear palsy.
Dana Wagshal, Sethu Sankaranarayanan, Valerie Guss, Tracey Hall, Flora Berisha

J Neurol Neurosurg Psychiatry· March 2015

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Characterization of novel CSF Tau and ptau biomarkers for Alzheimer's disease.
Jere E Meredith, Sethu Sankaranarayanan, Valerie Guss, Anthony J Lanzetti, Flora Berisha

PLoS One· August 2014

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Cerebrospinal fluid neurofilament concentration reflects disease severity in frontotemporal degeneration.
Carole S Scherling, Tracey Hall, Flora Berisha, Kristen Klepac, Anna Karydas

Ann Neurol· January 2014

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Addressing drug effects on cut point determination for an anti-drug antibody assay.
Maria D F S Barbosa, Carol R Gleason, Kelli R Phillips, Flora Berisha, Bruce Stouffer

J Immunol Methods· October 2012

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