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Safe drug use in long QT syndrome and Brugada syndrome: comparison of website statistics.
Published in:
EP: Europace, 2013, v. 15, n. 7, p. 1042, doi. 10.1093/europace/eut018
By:
- Postema, Pieter G.;
- Neville, Jon;
- de Jong, Jonas S.S.G.;
- Romero, Klaus;
- Wilde, Arthur A.M.;
- Woosley, Raymond L.
Publication type:
Article
Landscape analysis for a neonatal disease progression model of bronchopulmonary dysplasia: Leveraging clinical trial experience and real-world data.
Published in:
Frontiers in Pharmacology, 2022, v. 13, p. 1, doi. 10.3389/fphar.2022.988974
By:
- Barrett, Jeffrey S.;
- Pane, Megan Cala;
- Knab, Timothy;
- Roddy, William;
- Beusmans, Jack;
- Jordie, Eric;
- Singh, Kanwaljit;
- Davis, Jonathan Michael;
- Romero, Klaus;
- Padula, Michael;
- Thebaud, Bernard;
- Turner, Mark
Publication type:
Article
Elements for Adequate Informed Consent in the Surgical Context.
Published in:
World Journal of Surgery, 2014, v. 38, n. 7, p. 1594, doi. 10.1007/s00268-014-2588-x
By:
- Abaunza, Hernando;
- Romero, Klaus
Publication type:
Article
Economic Burden and Disparities in Healthcare Resource Use Among Adult Patients with Cardiac Arrhythmia.
Published in:
Applied Health Economics & Health Policy, 2014, v. 12, n. 1, p. 59, doi. 10.1007/s40258-013-0070-9
By:
- Tang, Derek;
- Gilligan, Adrienne;
- Romero, Klaus
Publication type:
Article
Development of Clinical Trial Simulation Tools for Alzheimer's Disease through the Critical Path for Alzheimer's Disease (CPAD) Consortium.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, n. 21, p. 1, doi. 10.1002/alz.074773
By:
- Sivakumaran, Sudhir;
- Cullen, Nicholas;
- Lau, Corissa;
- Priest, Eileen;
- White, Hazel;
- Irizarry, Michael C.;
- Romero, Klaus;
- Karten, Yashmin
Publication type:
Article
Towards a standardized pipeline for tau PET analysis under a GAAIN/LONI and CPAD collaborative framework.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, p. 1, doi. 10.1002/alz.076995
By:
- Toga, Arthur W.;
- Pappas, Ioannis;
- Leuzy, Antoine;
- Karten, Yashmin;
- Weber, Christopher J.;
- Romero, Klaus;
- Sivakumaran, Sudhir
Publication type:
Article
Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, n. 2, p. 696, doi. 10.1002/alz.12737
By:
- Langbaum, Jessica B.;
- Zissimopoulos, Julie;
- Au, Rhoda;
- Bose, Niranjan;
- Edgar, Chris J.;
- Ehrenberg, Evan;
- Fillit, Howard;
- Hill, Carl V.;
- Hughes, Lynne;
- Irizarry, Michael;
- Kremen, Sarah;
- Lakdawalla, Darius;
- Lynn, Nancy;
- Malzbender, Kristina;
- Maruyama, Tetsuyuki;
- Massett, Holly A.;
- Patel, Deep;
- Peneva, Desi;
- Reiman, Eric M.;
- Romero, Klaus
Publication type:
Article
ALZ‐NET: Using Real World Evidence to Inform the Future of Alzheimer's Treatment and Care.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2022, v. 18, n. 10, p. 1, doi. 10.1002/alz.069542
By:
- Rabinovici, Gil D.;
- Rafii, Michael S;
- Apgar, Charles;
- An, Na;
- Barakos, Jerome;
- Brangman, Sharon A;
- Daffner, Kirk R;
- Edelmayer, Rebecca M.;
- Gatsonis, Constantine;
- Hakim, Rosemarie;
- Hanna, Lucy;
- Jicha, Gregory A;
- Jordan, John;
- Lingler, Jennifer H;
- Lopez, Oscar L.;
- March, Andrew;
- Porsteinsson, Anton P.;
- Possin, Katherine L;
- Romero, Klaus;
- Salloway, Stephen P.
Publication type:
Article
Development of Clinical Trial Simulation Tools for Alzheimer's Disease through the Critical Path for Alzheimer's Disease (CPAD) Consortium.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2022, v. 18, n. 10, p. 1, doi. 10.1002/alz.059971
By:
- Sivakumaran, Sudhir;
- Cui, Zihan;
- Priest, Eileen;
- Lau, Corissa;
- White, Hazel;
- Irizarry, Michael C;
- Romero, Klaus;
- Karten, Yashmin
Publication type:
Article
Correlations and associations between fluid‐based and morphometric imaging biomarkers through interrogation and integration of data and analysis across two data platforms.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2022, v. 18, n. 6, p. 1, doi. 10.1002/alz.060679
By:
- Toga, Arthur W.;
- Henscheid, Nicholas;
- Pappas, Ioannis;
- Cabeen, Ryan P;
- Podichetty, Jagdeep;
- Hobel, Sam;
- Weber, Christopher J.;
- Sivakumaran, Sudhir;
- Romero, Klaus
Publication type:
Article
The Critical Path for Alzheimer's Disease (CPAD) Consortium: A platform for pre‐competitive data sharing, standardization, and analysis to support quantitative tools for AD drug development.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2021, v. 17, p. 1, doi. 10.1002/alz.051903
By:
- Sivakumaran, Sudhir;
- Hanan, Nathan J;
- Cui, Zihan;
- Burton, Jackson;
- Lang, Patrick;
- Priest, Eileen;
- White, Hazel;
- Romero, Klaus;
- Karten, Yashmin
Publication type:
Article
Graphical user interfaces for regulatory‐endorsed quantitative drug development tools in Alzheimer's disease: Human/Trial design.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2020, v. 16, n. 11, p. 1, doi. 10.1002/alz.044029
By:
- Romero, Klaus;
- Hanan, Nathan J.;
- Sivakumaran, Sudhir;
- Sinha, Vikram;
- Haeberlein, Samantha Budd;
- Gold, Michael
Publication type:
Article
The Critical Path for Alzheimer's Disease (CPAD): Pre‐competitive data sharing and generation of innovative high‐impact quantitative tools to support Alzheimer's disease drug development: Human/Trial design.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2020, v. 16, n. 11, p. 1, doi. 10.1002/alz.043919
By:
- Sivakumaran, Sudhir;
- Romero, Klaus;
- Hanan, Nathan J;
- Sinha, Vikram;
- Haeberlein, Samantha Budd;
- Gold, Michael
Publication type:
Article
Generation of a comprehensive disease progression model across the Alzheimer's disease continuum: Human/Trial design.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2020, v. 16, n. 11, p. 1, doi. 10.1002/alz.043258
By:
- Hanan, Nathan J.;
- Sivakumaran, Sudhir;
- Sinha, Vikram;
- Haeberlein, Samantha Budd;
- Gold, Michael;
- Romero, Klaus
Publication type:
Article
P4‐253: THE CRITICAL PATH FOR ALZHEIMER'S DISEASE (CPAD) CONSORTIUM – A PRE‐COMPETITIVE, GLOBAL, INTEGRATED, AND STANDARDIZED ALZHEIMER DISEASE CLINICAL TRIAL DATA SHARING REPOSITORY TO SUPPORT AD DRUG DEVELOPMENT.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2019, v. 15, p. P1376, doi. 10.1016/j.jalz.2019.06.3922
By:
- Arnerić, Stephen P.;
- Haeberlein, Samantha Budd;
- Dunn, Billy;
- Gold, Michael;
- Kern, Volker D.;
- Conrado, Daniela J.;
- Romero, Klaus;
- Brumfield, Martha A.
Publication type:
Article
P4‐090: THE CRITICAL PATH FOR ALZHEIMER'S DISEASE (CPAD) CONSORTIUM: FACILITATING RAPID DATA AND INFORMATION SHARING BY ESTABLISHING A SUSTAINABLE, INTEGRATED, AND STANDARDIZED PLATFORM ADVANCING KNOWLEDGE TO ENABLE EXPEDITED DRUG DEVELOPMENT.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2018, v. 14, p. P1470, doi. 10.1016/j.jalz.2018.06.2493
By:
- Arnerić, Stephen P.;
- Kern, Volker D.;
- Gold, Lisa H.;
- Romero, Klaus;
- Dunn, Billy;
- Carrillo, Maria C.;
- Weninger, Stacie;
- Brumfield, Martha A.
Publication type:
Article
P3‐031: THE CRITICAL PATH FOR ALZHEIMER'S DISEASE: HIPPOCAMPAL VOLUME AS AN ENRICHMENT BIOMARKER IN TRIALS OF PATIENTS WITH MILD COGNITIVE IMPAIRMENT.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2018, v. 14, p. P1076, doi. 10.1016/j.jalz.2018.06.1386
By:
- Conrado, Daniela J.;
- Nicholas, Timothy;
- Burton, Jackson;
- Arnerić, Stephen P.;
- Chen, Danny;
- Stone, Julie A.;
- Sinha, Vikram;
- Willis, Brian A.;
- Kern, Volker D.;
- Hill, Derek L.;
- Novak, Gerald P.;
- Gold, Lisa H.;
- Cole, Patricia E.;
- Matthews, Dawn C.;
- Xie, Zhiyong;
- Wang, Wenping;
- Hendrix, James;
- Wolz, Robin;
- Gordon, Mark Forrest;
- Romero, Klaus
Publication type:
Article
THE COALITION AGAINST MAJOR DISEASES: TOWARD U.S. FDA QUALIFICATION OF HIPPOCAMPAL VOLUME AS A BIOMARKER FOR ENRICHMENT IN CLINICAL TRIALS FOR PRE-DEMENTIA STAGES OF ALZHEIMER'S DISEASE.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2017, v. 13, p. P1259, doi. 10.1016/j.jalz.2017.06.1878
By:
- Conrado, Daniela J.;
- Romero, Klaus;
- Corrigan, Brian;
- Ito, Kaori;
- Nicholas, Timothy;
- Chen, Danny;
- Samtani, Mahesh N.;
- Stone, Julie;
- Sinha, Vikram;
- Willis, Brian A.;
- Kern, Volker D.;
- Hill, Derek L.;
- Cole, Patricia E.;
- Novak, Gerald P.;
- Meibach, Richard;
- Matthews, Dawn C.;
- Schwarz, Adam J.;
- Xie, Zhiyong;
- Gordon, Mark Forrest;
- Arneric, Stephen P.
Publication type:
Article
Big data to smart data in Alzheimer's disease: Real-world examples of advanced modeling and simulation.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2016, v. 12, n. 9, p. 1022, doi. 10.1016/j.jalz.2016.05.005
By:
- Haas, Magali;
- Stephenson, Diane;
- Romero, Klaus;
- Gordon, Mark Forrest;
- Zach, Neta;
- Geerts, Hugo
Publication type:
Article
Big data to smart data in Alzheimer's disease: The brain health modeling initiative to foster actionable knowledge.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2016, v. 12, n. 9, p. 1014, doi. 10.1016/j.jalz.2016.04.008
By:
- Geerts, Hugo;
- Dacks, Penny A.;
- Devanarayan, Viswanath;
- Haas, Magali;
- Khachaturian, Zaven S.;
- Gordon, Mark Forrest;
- Maudsley, Stuart;
- Romero, Klaus;
- Stephenson, Diane
Publication type:
Article
Development of a unified clinical trial database for Alzheimer's disease.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2015, v. 11, n. 10, p. 1212, doi. 10.1016/j.jalz.2014.11.005
By:
- Neville, Jon;
- Kopko, Steve;
- Broadbent, Steve;
- Avilés, Enrique;
- Stafford, Robert;
- Solinsky, Christine M.;
- Bain, Lisa J.;
- Cisneroz, Martin;
- Romero, Klaus;
- Stephenson, Diane
Publication type:
Article
Quantifying the placebo effect through modeling and simulation.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2015, v. 11, n. 7, p. P210, doi. 10.1016/j.jalz.2015.07.218
By:
- Romero, Klaus;
- Ito, Kaori;
- Corrigan, Brian;
- Anziano, Richard J.;
- Neville, Jon;
- Stephenson, Diane;
- Lalonde, Richard
Publication type:
Article
The path to regulatory qualification of cerebrospinal fluid biomarkers as enrichment tools in clinical trials of patients with early Alzheimer’s disease: For the coalition against major diseases.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2015, v. 11, n. 7, p. P296, doi. 10.1016/j.jalz.2015.07.406
By:
- Vanderstichele, Hugo Marcel;
- Stephenson, Diane;
- Shaw, Leslie M.;
- Carrillo, Maria;
- Umek, Robert;
- Rajapakse, Hemaka;
- Luthman, Johan;
- Soares, Holly;
- Gordon, Mark Forrest;
- Devanarayan, Viswanath;
- Genius, Just;
- Berman, Robert;
- Hendrix, James;
- Romero, Klaus;
- Kaplow, June;
- Willis, Brian;
- Hitchcock, Janice;
- Yu, Peng;
- Lawson, John;
- Raunig, David
Publication type:
Article
Advancement of a drug-disease trial model for Alzheimer's disease through a regulatory science path: The CAMD experience
Published in:
2012
By:
- Romero, Klaus;
- Stephenson, Diane;
- Rogers, James;
- Polhamus, Dan;
- Ito, Kaori;
- Qiu, Ruolun;
- Corrigan, Brian
Publication type:
Abstract
Model-based analysis to support strategic decision-making: A case study from the development of a 5HT6 antagonist for the treatment of Alzheimer's disease
Published in:
2012
By:
- Rogers, James;
- Polhamus, Dan;
- Lockwood, Peter;
- Brault, Yves;
- Desmet, Anne;
- Ito, Kaori;
- Romero, Klaus;
- Qiu, Ruolun;
- Corrigan, Brian;
- Gillespie, William;
- Gastonguay, Marc
Publication type:
Abstract
Integration of data for a model-based longitudinal meta-analysis of cognitive changes in mild and moderate Alzheimer's patients
Published in:
2012
By:
- Rogers, James;
- Polhamus, Dan;
- Ito, Kaori;
- Romero, Klaus;
- Qiu, Ruolun;
- Gillespie, William;
- Corrigan, Brian
Publication type:
Abstract
Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials.
Published in:
Frontiers in Neurology, 2021, v. 12, p. 1, doi. 10.3389/fneur.2021.712565
By:
- Kinnunen, Kirsi M.;
- Mullin, Ariana P.;
- Pustina, Dorian;
- Turner, Emily C.;
- Burton, Jackson;
- Gordon, Mark F.;
- Scahill, Rachael I.;
- Gantman, Emily C.;
- Noble, Simon;
- Romero, Klaus;
- Georgiou-Karistianis, Nellie;
- Schwarz, Adam J.
Publication type:
Article
Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin.
Published in:
AAPS Journal, 2018, v. 20, n. 3, p. 1, doi. 10.1208/s12248-018-0199-4
By:
- Patel, Nikunjkumar;
- Hatley, Oliver;
- Berg, Alexander;
- Romero, Klaus;
- Wisniowska, Barbara;
- Hanna, Debra;
- Hermann, David;
- Polak, Sebastian
Publication type:
Article
Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders.
Published in:
2019
By:
- Mulberg, Andrew E.;
- Bucci-Rechtweg, Christina;
- Giuliano, Joseph;
- Jacoby, David;
- Johnson, Franklin K.;
- Liu, Qing;
- Marsden, Deborah;
- McGoohan, Scott;
- Nelson, Robert;
- Patel, Nita;
- Romero, Klaus;
- Sinha, Vikram;
- Sitaraman, Sheela;
- Spaltro, John;
- Kessler, Vivian
Publication type:
journal article
Nonclinical models for antituberculosis drug development: a landscape analysis.
Published in:
2015
By:
- Gumbo, Tawanda;
- Lenaerts, Anne J;
- Hanna, Debra;
- Romero, Klaus;
- Nuermberger, Eric
Publication type:
Journal Article
Apolipoprotein E Genotype and Sex Risk Factors for Alzheimer Disease AMeta-analysis.
Published in:
JAMA Neurology, 2017, v. 74, n. 10, p. 1178, doi. 10.1001/jamaneurol.2017.2188
By:
- Neu, Scott C.;
- Judy Pa;
- Kukull, Walter;
- Beekly, Duane;
- Kuzma, Amanda;
- Gangadharan, Prabhakaran;
- Li-SanWang;
- Romero, Klaus;
- Arneric, Stephen P.;
- Redolfi, Alberto;
- Orlandi, Daniele;
- Frisoni, Giovanni B.;
- Au, Rhoda;
- Devine, Sherral;
- Auerbach, Sanford;
- Espinosa, Ana;
- Boada, Mercè;
- Ruiz, Agustín;
- Johnson, Sterling C.;
- Koscik, Rebecca
Publication type:
Article
Duchenne Regulatory Science Consortium Meeting on Disease Progression Modeling for Duchenne Muscular Dystrophy.
Published in:
PLoS Currents, 2017, p. 59, doi. 10.1371/currents.md.83071bbd728982f2f1073f4950e03586
By:
- Larkindale, Jane;
- Abresch, Richard;
- Aviles, Enrique;
- Bronson, Abby;
- Chin, Janice;
- Furlong, Pat;
- Gordish-Dressman, Heather;
- Habeeb-Louks, Elizabeth;
- Henricson, Erik;
- Kroger, Hans;
- Lynn, Charles;
- Lynn, Stephen;
- Martin, Dana;
- Nuckolls, Glen;
- Rooney, William;
- Romero, Klaus;
- Sweeney, Lee;
- Vandenborne, Krista;
- Walter, Glenn;
- Wolff, Jodi
Publication type:
Article
Time to Replace Bazett's QT-Correction.
Published in:
Pacing & Clinical Electrophysiology, 2009, v. 32, n. 11, p. 1379, doi. 10.1111/j.1540-8159.2009.02513.x
By:
- WOOSLEY, RAYMOND L.;
- ROMERO, KLAUS
Publication type:
Article
Correlations Between the Hollow Fiber Model of Tuberculosis and Therapeutic Events in Tuberculosis Patients: Learn and Confirm.
Published in:
Clinical Infectious Diseases, 2015, v. 61, p. S18, doi. 10.1093/cid/civ426
By:
- Gumbo, Tawanda;
- Pasipanodya, Jotam G.;
- Nuermberger, Eric;
- Romero, Klaus;
- Hanna, Debra
Publication type:
Article
Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.
Published in:
Clinical Infectious Diseases, 2015, v. 61, p. S5, doi. 10.1093/cid/civ424
By:
- Romero, Klaus;
- Clay, Robert;
- Hanna, Debra
Publication type:
Article
Systematic Analysis of Hollow Fiber Model of Tuberculosis Experiments.
Published in:
Clinical Infectious Diseases, 2015, v. 61, p. S10, doi. 10.1093/cid/civ425
By:
- Pasipanodya, Jotam G.;
- Nuermberger, Eric;
- Romero, Klaus;
- Gumbo, Tawanda
Publication type:
Article
Forecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes.
Published in:
Clinical Infectious Diseases, 2015, v. 61, p. S25, doi. 10.1093/cid/civ427
By:
- Gumbo, Tawanda;
- Pasipanodya, Jotam G.;
- Romero, Klaus;
- Hanna, Debra;
- Nuermberger, Eric
Publication type:
Article
A Modern Curriculum for Training Scientists in Model‐Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 2, p. 289, doi. 10.1002/cpt.3039
By:
- Barrett, Jeffrey S.;
- Romero, Klaus;
- Rayner, Craig;
- Gastonguay, Marc;
- Pillai, Goonaseelan;
- Tannenbaum, Stacey;
- Kern, Steven;
- Selich, Mark;
- Francisco, Dave
Publication type:
Article
Unlocking the Capabilities of Large Language Models for Accelerating Drug Development.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 1, p. 38, doi. 10.1002/cpt.3279
By:
- Anderson, Wes;
- Braun, Ian;
- Bhatnagar, Roopal;
- Romero, Klaus;
- Walls, Ramona;
- Schito, Marco;
- Podichetty, Jagdeep T.
Publication type:
Article
T1dCteGui: A User‐Friendly Clinical Trial Enrichment Tool to Optimize T1D Prevention Studies by Leveraging AI/ML Based Synthetic Patient Population.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 114, n. 3, p. 704, doi. 10.1002/cpt.2976
By:
- Pauley, Mike;
- Henscheid, Nick;
- David, Sarah E.;
- Karpen, Stephen R.;
- Romero, Klaus;
- Podichetty, Jagdeep T.
Publication type:
Article
Leveraging Real‐World Data for EMA Qualification of a Model‐Based Biomarker Tool to Optimize Type‐1 Diabetes Prevention Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 5, p. 1133, doi. 10.1002/cpt.2559
By:
- Podichetty, Jagdeep T.;
- Lang, Patrick;
- O'Doherty, Inish M.;
- David, Sarah E.;
- Muse, Rhoda N.;
- Karpen, Stephen R.;
- Song, Laura Sue;
- Romero, Klaus;
- Burton, Jackson K.
Publication type:
Article
Challenges in Alzheimer's Disease Drug Discovery and Development: The Role of Modeling, Simulation, and Open Data.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 796, doi. 10.1002/cpt.1782
By:
- Conrado, Daniela J.;
- Duvvuri, Sridhar;
- Geerts, Hugo;
- Burton, Jackson;
- Biesdorf, Carla;
- Ahamadi, Malidi;
- Macha, Sreeraj;
- Hather, Gregory;
- Francisco Morales, Juan;
- Podichetty, Jagdeep;
- Nicholas, Timothy;
- Stephenson, Diane;
- Trame, Mirjam;
- Romero, Klaus;
- Corrigan, Brian
Publication type:
Article
Open Data for Clinical Pharmacology.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 703, doi. 10.1002/cpt.1779
By:
- Burton, Jackson;
- Bhattacharya, Sanchita;
- Romero, Klaus;
- Conrado, Daniela J.
Publication type:
Article
Hippocampal Neuroimaging‐Informed Clinical Trial Enrichment Tool for Amnestic Mild Cognitive Impairment Using Open Data.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 903, doi. 10.1002/cpt.1766
By:
- Conrado, Daniela J.;
- Burton, Jackson;
- Hill, Derek;
- Willis, Brian;
- Sinha, Vikram;
- Stone, Julie;
- Coello, Neva;
- Wang, Wenping;
- Chen, Danny;
- Nicholas, Timothy;
- Gold, Michael;
- Hartley, Emily;
- Kern, Volker D.;
- Romero, Klaus
Publication type:
Article
Type 1 diabetes prevention clinical trial simulator: Case reports of model‐informed drug development tool.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2024, v. 13, n. 8, p. 1309, doi. 10.1002/psp4.13193
By:
- Morales, Juan Francisco;
- Klose, Marian;
- Hoffert, Yannick;
- Podichetty, Jagdeep T.;
- Burton, Jackson;
- Schmidt, Stephan;
- Romero, Klaus;
- O'Doherty, Inish;
- Martin, Frank;
- Campbell‐Thompson, Martha;
- Haller, Michael J.;
- Atkinson, Mark A.;
- Kim, Sarah
Publication type:
Article
Disease progression joint model predicts time to type 1 diabetes onset: Optimizing future type 1 diabetes prevention studies.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 7, p. 1016, doi. 10.1002/psp4.12973
By:
- Morales, Juan Francisco;
- Muse, Rhoda;
- Podichetty, Jagdeep T.;
- Burton, Jackson;
- David, Sarah;
- Lang, Patrick;
- Schmidt, Stephan;
- Romero, Klaus;
- O'Doherty, Inish;
- Martin, Frank;
- Campbell‐Thompson, Martha;
- Haller, Michael J.;
- Atkinson, Mark A.;
- Kim, Sarah
Publication type:
Article
Development of a model‐based clinical trial simulation platform to optimize the design of clinical trials for Duchenne muscular dystrophy.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2022, v. 11, n. 3, p. 318, doi. 10.1002/psp4.12753
By:
- Lingineni, Karthik;
- Aggarwal, Varun;
- Morales, Juan Francisco;
- Conrado, Daniela J.;
- Corey, Diane;
- Vong, Camille;
- Burton, Jackson;
- Larkindale, Jane;
- Romero, Klaus;
- Schmidt, Stephan;
- Kim, Sarah;
- McDonald, C;
- Henricson, E;
- Cregan, M;
- Johnson, L;
- Han, J;
- Joyce, N;
- Nicorici, A;
- Reddy, D;
- Mah, J
Publication type:
Article
Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 11, p. 1382, doi. 10.1002/psp4.12707
By:
- Humphries, Helen;
- Almond, Lisa;
- Berg, Alexander;
- Gardner, Iain;
- Hatley, Oliver;
- Pan, Xian;
- Small, Ben;
- Zhang, Mian;
- Jamei, Masoud;
- Romero, Klaus
Publication type:
Article
Pharmacometrics as a Discipline Is Entering the “Industrialization” Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success.
Published in:
Journal of Clinical Pharmacology, 2010, v. 50, n. 9, p. 9S, doi. 10.1177/0091270010377788
By:
- Romero, Klaus;
- Corrigan, Brian;
- Tornoe, Christoffer W.;
- Gobburu, Jogarao V.;
- Danhof, Meindert;
- Gillespie, William R.;
- Gastonguay, Marc R.;
- Meibohm, Bernd;
- Derendorf, Hartmut
Publication type:
Article
Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development.
Published in:
Journal of Pharmacokinetics & Pharmacodynamics, 2018, v. 45, n. 3, p. 457, doi. 10.1007/s10928-018-9580-2
By:
- Polak, Sebastian;
- Romero, Klaus;
- Berg, Alexander;
- Patel, Nikunjkumar;
- Jamei, Masoud;
- Hermann, David;
- Hanna, Debra
Publication type:
Article

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