Milton Bonelli
London, ENG, United Kingdom
Last Updated: 09/26/2026
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Found 11 publications
EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals.
Journal: British journal of clinical pharmacology
Published: April 20, 2023
Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
Journal: Pharmaceutics
Published: September 21, 2022
A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
Journal: Clinical pharmacology and therapeutics
Published: June 29, 2021
Towards a better use of scientific advice for developers of advanced therapies.
Journal: British journal of clinical pharmacology
Published: July 22, 2020
Response to: "The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials".
Response to: "The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials".
Journal: Clinical pharmacology and therapeutics
Published: June 08, 2018
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.
Journal: British journal of clinical pharmacology
Published: February 17, 2018
Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective.
Journal: Clinical pharmacology and therapeutics
Published: September 13, 2017
Impact analysis of ICH S9 on non-clinical development of anticancer drugs.
Journal: Regulatory toxicology and pharmacology : RTP
Published: July 16, 2015
Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.
Journal: Regulatory toxicology and pharmacology : RTP
Published: December 19, 2013
Showing 1-11 of 11
Last Updated: 09/26/2026