Search Results - "Bonelli, Milton"

A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union by Paixao, Paulo, Garcia Arieta, Alfredo, Silva, Nuno, Petric, Zvonimir, Bonelli, Milton, Morais, José Augusto Guimarães, Blake, Kevin, Gouveia, Luís Filipe

“…In the European Union, bioequivalence (BE) for narrow therapeutic index (NTI) drugs is currently demonstrated when the 90% confidence interval for the ratio of…”
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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 by Paixão, Paulo, Silva, Nuno, Guerreiro, Rita Bento, Blake, Kevin, Bonelli, Milton, Morais, José Augusto Guimarães, García-Arieta, Alfredo, Gouveia, Luís Filipe

“…Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in the European Union is currently established by demonstrating that the 90%…”
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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 by Gerven, Joop, Bonelli, Milton

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

“…Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on…”
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Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective by Ponzano, Stefano, Blake, Kevin, Bonelli, Milton, Enzmann, Harald

“…The European Medicines Agency (EMA) revises its guideline on minimizing risk in first‐in‐human trials to reflect changing practice and in light of a recent…”
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A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union by Paixão, Paulo, Guerreiro, Rita Bento, Silva, Nuno, Blake, Kevin, Bonelli, Milton, Morais, Jose Augusto Guimarães, Garcia Arieta, Alfredo, Gouveia, Luis Filipe

“…The current regulatory criterion for bioequivalence of narrow therapeutic index (NTI) drugs in the European Union requires that the 90% confidence interval for…”
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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals by Laan, Jan Willem, Andersson, Mikael, Beken, Sonja, Bonelli, Milton, Brendler‐Schwaab, Susanne, Kane, Rosemary, Pasanen, Markku, Ponzano, Stefano, Paur, Jakob, Siezen, Christine, Soleng, Anne, Whomsley, Rhys

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

“…Cancer presents a major healthcare challenge worldwide, with several millions new cases a year, and represents a therapeutic area with a high need for new…”
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Safety Pharmacology Study Results and their Impact on the Design of First.in.human Trials for Authorised Oncology Therapies by O'Sullivan, Jane, Ponzano, Stefano, Bonelli, Milton

“…Background Safety pharmacology studies are conducted to elucidate possible safety risks on cardiovascular (CV), central nervous system (CNS) and respiratory…”
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Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions by Sheean, Maria E., Stoyanova-Beninska, Violeta, Capovilla, Giuseppe, Duarte, Dinah, Hofer, Matthias P., Hoffmann, Michel, Magrelli, Armando, Mariz, Segundo, Tsigkos, Stelios, Shaili, Evyenia, Polsinelli, Benedetta, Ricciardi, Mario, Bonelli, Milton, Balabanov, Pavel, Larsson, Kristina, Sepodes, Bruno

“…•Non-clinical models for 10 neurological rare conditions are reviewed.•Relevant study endpoints that can help support orphan applications are suggested.•COMP…”
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Safety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology Therapies by O’Sullivan, Jane, Ponzano, Stefano, Bonelli, Milton

“…Background Safety pharmacology studies are conducted to elucidate possible safety risks on cardiovascular (CV), central nervous system (CNS) and respiratory…”
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In vitro evaluation of 225Ac‐DOTA‐substance P for targeted alpha therapy of glioblastoma multiforme by Majkowska‐Pilip, Agnieszka, Rius, Maria, Bruchertseifer, Frank, Apostolidis, Christos, Weis, Mirjam, Bonelli, Milton, Laurenza, Marta, Królicki, Leszek, Morgenstern, Alfred

“…Glioblastoma multiforme (GBM) is the most malignant form of brain tumors with dismal prognosis despite treatment by surgery combined with radiotherapy and…”
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Response to: “The Role of Quantitative Systems Pharmacology in the Design of First‐in‐Human Trials” by Blake, Kevin, Bonelli, Milton, Ponzano, Stefano, Enzmann, Harald, Laan, Jan‐Willem, Jones, David, Wiesner, Lutz, Wändel‐Liminga, Ulla, Wydenbach, Kirsty, Stahl, Elke, Janssens, Walter, Masset, Dominique, El‐khoury, Joelle, Vella, Philippe, Welink, Jan

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

“…•Companies need to assess the effects on the environment deriving from use of medicines.•Half of new medicines in the last 2-years required phase I assessment…”
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In vitro evaluation of 225 Ac-DOTA-substance P for targeted alpha therapy of glioblastoma multiforme by Majkowska-Pilip, Agnieszka, Rius, Maria, Bruchertseifer, Frank, Apostolidis, Christos, Weis, Mirjam, Bonelli, Milton, Laurenza, Marta, Królicki, Leszek, Morgenstern, Alfred

“…Glioblastoma multiforme (GBM) is the most malignant form of brain tumors with dismal prognosis despite treatment by surgery combined with radiotherapy and…”
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