Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective.

Authors :: Ponzano S
Blake K
Bonelli M
Enzmann H
Source :: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2018 Apr; Vol. 103 (4), pp. 564-566. Date of Electronic Publication: 2017 Nov 06.
Publication Year :: 2018
Abstract: 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 tragic incident.<br /> (© 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Subjects :: Drug Development methods
Drug Development standards
Drug and Narcotic Control methods
Drug and Narcotic Control organization & administration
European Union
Humans
Clinical Protocols standards
Clinical Trials as Topic legislation & jurisprudence
Clinical Trials as Topic standards
Guidelines as Topic
Therapeutic Human Experimentation ethics
Therapeutic Human Experimentation legislation & jurisprudence

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