Publications in collaboration with researchers from United States Food and Drug Administration (21)

2021

  1. Core Outcome Measures for Trials in People with Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery

    Critical Care Medicine, Vol. 49, Núm. 3, pp. 503-516

  2. Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions

    European Neuropsychopharmacology, Vol. 48, pp. 3-31

  3. Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum

    Therapeutic Innovation and Regulatory Science, Vol. 55, Núm. 4, pp. 773-778

  4. The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group

    npj Breast Cancer, Vol. 7, Núm. 1

  5. Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers

    Clinical Infectious Diseases, Vol. 72, Núm. 11, pp. 2035-2041

2019

  1. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

    The Lancet Respiratory Medicine, Vol. 7, Núm. 11, pp. 951-963

  2. Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary

    European Heart Journal: Acute Cardiovascular Care, Vol. 8, Núm. 8, pp. 745-754

2018

  1. Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project

    Allergy: European Journal of Allergy and Clinical Immunology, Vol. 73, Núm. 4, pp. 816-826

  2. Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

    Allergy: European Journal of Allergy and Clinical Immunology, Vol. 73, Núm. 1, pp. 64-76

  3. Radiotherapeutic implications of the updated ICRP thresholds for tissue reactions related to cataracts and circulatory diseases

    Annals of the ICRP, Vol. 47, Núm. 3-4, pp. 196-213

2017

  1. Neutral evolution of drug resistant colorectal cancer cell populations is independent of their KRAS status

    PLoS ONE, Vol. 12, Núm. 10

  2. Optimizing research to speed up availability of pediatric antiretroviral drugs and formulations

    Clinical Infectious Diseases, Vol. 64, Núm. 11, pp. 1597-1603

2016

  1. Erratum to: Guidelines for the use and interpretation of assays for monitoring autophagy (3rd edition) (Autophagy, 12, 1, 1-222, 10.1080/15548627.2015.1100356

    Autophagy

  2. Guidelines for the use and interpretation of assays for monitoring autophagy (3rd edition)

    Autophagy, Vol. 12, Núm. 1, pp. 1-222

2015

  1. Distinct Trafficking of Cell Surface and Endosomal TIM-1 to the Immune Synapse

    Traffic, Vol. 16, Núm. 11, pp. 1193-1207

  2. Implications in medical imaging of the new ICRP thresholds for tissue reactions

    Annals of the ICRP, Vol. 44, pp. 118-128

  3. Overview of ICRP Committee 3 ‘Protection in Medicine’

    Annals of the ICRP, Vol. 44, pp. 24-32

  4. Overview of ICRP Committee 3: protection in medicine

    Annals of the ICRP, Vol. 45, pp. 25-33

2008

  1. Methods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients withd-heumatoid arthritis

    Annals of the Rheumatic Diseases, Vol. 67, Núm. 10, pp. 1365-1373

  2. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

    Arthritis Care and Research, Vol. 59, Núm. 10, pp. 1371-1377