Getting a molecule into the clinic: Nonclinical testing and starting dose considerations-Reference-Cited by-同舟云学术

Getting a molecule into the clinic: Nonclinical testing and starting dose considerations

Published:2017-10 Issue: Volume:89 Page:95-100
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Baldrick Paul

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference17 articles.

1. Safety evaluation to support First-In-Man investigations I: kinetic and safety pharmacology studies;Baldrick;Reg. Tox. Pharm.,2008

2. Safety evaluation to support First-In-Man investigations II: toxicology studies;Baldrick;Reg. Tox. Pharm.,2008

3. European Medicines Agency: Guideline on the Investigation of Drug Interactions;EMA,2012

4. European Medicines Agency: Draft Guideline on Strategies to Identify and Mitigate Risks for First-in-human and Early Clinical Trials with Investigational Medicinal Products;EMA,2016

5. European Medicines Agency: Guideline on Strategies to Identify and Mitigate Risks for First-inhuman Clinical Trials with Investigational Medicinal Products;EMEA,2007

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