Milton Bonelli

Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions.

S. Tsigkos, Matthias P. Hofer, Maria E Sheean, 2018, Drug discovery today.

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products

J. V. van Gerven, Joop van Gerven, Milton Bonelli, 2018, British journal of clinical pharmacology.

EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

J. W. van der Laan, M. Pasanen, S. Beken, 2023, British journal of clinical pharmacology.

Impact analysis of ICH S9 on non-clinical development of anticancer drugs.

F. Di Giuseppe, S. Beken, Milton Bonelli, 2015, Regulatory toxicology and pharmacology : RTP.

Safety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology Therapies

Milton Bonelli, S. Ponzano, Jane O’Sullivan, 2018, Pharmaceutical Medicine.

Towards a better use of scientific advice for developers of advanced therapies

A. Tavridou, A. Hidalgo‐Simon, Milton Bonelli, 2020, British journal of clinical pharmacology.