Lorenzo Guizzaro

Naples, Italy

Last Updated: 09/26/2026

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Found 25 publications

Balancing benefit and risk in early Alzheimer's disease: the European Medicines Agency (EMA) assessment of lecanemab and donanemab.

Balancing benefit and risk in early Alzheimer's disease: the European Medicines Agency (EMA) assessment of lecanemab and donanemab.

Journal: The Lancet regional health. Europe

Published: November 20, 2025

A model structure for describing uncertainties in benefit-risk assessment of oncology drug applications.

A model structure for describing uncertainties in benefit-risk assessment of oncology drug applications.

Journal: Frontiers in medicine

Published: March 07, 2025

EU regulatory horizons for Alzheimer's disease.

EU regulatory horizons for Alzheimer's disease.

Journal: The Lancet. Neurology

Published: December 03, 2024

A review of psychedelics trials completed in depression, informed by European regulatory perspectives.

A review of psychedelics trials completed in depression, informed by European regulatory perspectives.

Journal: Neuroscience applied

Published: October 30, 2024

Biomarkers for neurodegenerative diseases in regulatory decision-making by the European Medicines Agency.

Biomarkers for neurodegenerative diseases in regulatory decision-making by the European Medicines Agency.

Journal: Alzheimer's & dementia (New York, N. Y.)

Published: October 22, 2024

Estimands in equivalence trials and non-inferiority trials: a cross-sectional study of EMA scientific advice to drug developers.

Estimands in equivalence trials and non-inferiority trials: a cross-sectional study of EMA scientific advice to drug developers.

Journal: Trials

Published: June 06, 2024

Estimation Methods for Estimands Using the Treatment Policy Strategy; a Simulation Study Based on the PIONEER 1 Trial.

Estimation Methods for Estimands Using the Treatment Policy Strategy; a Simulation Study Based on the PIONEER 1 Trial.

Journal: Pharmaceutical statistics

Published: February 19, 2024

Preferences about Future Alzheimer's Disease Treatments Elicited through an Online Survey Using the Threshold Technique.

Preferences about Future Alzheimer's Disease Treatments Elicited through an Online Survey Using the Threshold Technique.

Journal: The journal of prevention of Alzheimer's disease

Published: October 24, 2023

Estimands in CNS trials - A review of strategies for addressing intercurrent events.

Estimands in CNS trials - A review of strategies for addressing intercurrent events.

Journal: Contemporary clinical trials communications

Published: July 12, 2023

Developing medicines for the pre-symptomatic stage of degenerative neurological conditions: Challenges and opportunities.

Developing medicines for the pre-symptomatic stage of degenerative neurological conditions: Challenges and opportunities.

Journal: Revue neurologique

Published: May 25, 2023

Clinically Manifest Infections Do Not Increase the Relapse Risk in People with Multiple Sclerosis Treated with Disease-Modifying Therapies: A Prospective Study.

Clinically Manifest Infections Do Not Increase the Relapse Risk in People with Multiple Sclerosis Treated with Disease-Modifying Therapies: A Prospective Study.

Journal: Journal of clinical medicine

Published: December 08, 2022

The Impact of COVID-19 on the Initiation of Clinical Trials in Europe and the United States.

The Impact of COVID-19 on the Initiation of Clinical Trials in Europe and the United States.

Journal: Clinical pharmacology and therapeutics

Published: December 03, 2021

Showing 1-12 of 25

Last Updated: 09/26/2026