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Literature DB >> 29851119

Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP.

Adam Cohen¹, Sergio Bonini².

Abstract

Mesh：

Year: 2018 PMID： 29851119 PMCID： PMC6005623 DOI： 10.1111/bcp.13599

Source DB: PubMed Journal: Br J Clin Pharmacol ISSN： 0306-5251 Impact factor: 4.335

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4 in total

1. Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP.

Authors: Adam Cohen; Sergio Bonini
Journal: Br J Clin Pharmacol Date: 2018-05-30 Impact factor: 4.335

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

Authors: Joop van Gerven; Milton Bonelli
Journal: Br J Clin Pharmacol Date: 2018-05-30 Impact factor: 4.335

3. Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase.

Authors: Anne Kerbrat; Jean-Christophe Ferré; Pierre Fillatre; Thomas Ronzière; Stéphane Vannier; Béatrice Carsin-Nicol; Sylvain Lavoué; Marc Vérin; Jean-Yves Gauvrit; Yves Le Tulzo; Gilles Edan
Journal: N Engl J Med Date: 2016-11-03 Impact factor: 91.245

4. Implications of the BIA-102474-101 study for review of first-into-human clinical trials.

Authors: Michael Eddleston; Adam F Cohen; David J Webb
Journal: Br J Clin Pharmacol Date: 2016-04 Impact factor: 4.335

4 in total

5 in total

1. Regulatory science: Regulation is too important to leave it to the regulators.

Authors: Hubert G Leufkens
Journal: Br J Clin Pharmacol Date: 2019-04-10 Impact factor: 4.335

2. Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP.