Publications by authors named "Milton Bonelli"

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A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union.
Paulo Paixao, Alfredo Garcia Arieta, Nuno Silva, Zvonimir Petric, Milton Bonelli

Pharmaceutics· April 2024

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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals.
Jan Willem van der Laan, Mikael Andersson, Sonja Beken, Milton Bonelli, Susanne Brendler-Schwaab

Br J Clin Pharmacol· August 2023

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Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
Paulo Paixão, Nuno Silva, Rita Bento Guerreiro, Kevin Blake, Milton Bonelli

Pharmaceutics· October 2022

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A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
Paulo Paixão, Rita Bento Guerreiro, Nuno Silva, Kevin Blake, Milton Bonelli

Clin Pharmacol Ther· February 2022

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Towards a better use of scientific advice for developers of advanced therapies.
Anna Tavridou, Dolca Rogers, Milton Bonelli, Anja Schiel, Ana Hidalgo-Simon

Br J Clin Pharmacol· June 2021

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Response to: "The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials".
Kevin Blake, Milton Bonelli, Stefano Ponzano, Harald Enzmann,

Clin Pharmacol Ther· November 2018

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Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.
Joop van Gerven, Milton Bonelli

Br J Clin Pharmacol· July 2018

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In vitro evaluation of Ac-DOTA-substance P for targeted alpha therapy of glioblastoma multiforme.
Agnieszka Majkowska-Pilip, Maria Rius, Frank Bruchertseifer, Christos Apostolidis, Mirjam Weis, Milton Bonelli

Chem Biol Drug Des· July 2018

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Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective.
Stefano Ponzano, Kevin Blake, Milton Bonelli, Harald Enzmann,

Clin Pharmacol Ther· April 2018

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Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions.
Maria E Sheean, Violeta Stoyanova-Beninska, Giuseppe Capovilla, Dinah Duarte, Matthias P Hofer, Milton Bonelli

Drug Discov Today· January 2018

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Impact analysis of ICH S9 on non-clinical development of anticancer drugs.
Milton Bonelli, Francesca Di Giuseppe, Sonja Beken

Regul Toxicol Pharmacol· October 2015

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Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.
Laura Caneva, Milton Bonelli, Marisa Papaluca-Amati, Jean-Marc Vidal

Regul Toxicol Pharmacol· April 2014

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